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Posts Tagged ‘MDL-926 claim’

Dow Corning Breast Implant Claims , Adverse Indicent Report

Written by lisaspitzer on . Posted in Breast Implant Blog

MAUDE Adverse Event Report: DOW CORNING CORP.DOW CORNINGSILICONE GEL BREAST IMPLANT. Dow Corning Trust Claims are still active. If you have filed a Dow Corning Claim and Need help call our Dow Corning Claims lawyers today.



Rptr had initial breast implants placed following mastectomy for/ to prevent cancer. Rptr claims she has had the right implant replaced once. She has had two breast surgeries on the left, and four breast surgeries in the right; all beginning with the first implant surgery. Rptr does not have implants in now, does not know if calcium deposits occurred, and states that no biopsies were performed on tissue samples. Medical professionals have not confirmed silicone outside the breast scar tissue capsule. Rptr claims that the left heyer-shulte implant ruptured, and she had one capsular contracture. Rptr claims that the right heyer-shulte implant became a "painful contracture", and that this implant was "traveling from the original site, requiring removal". Rptr states that the dow corining implant was removed "intact", and that she suffered one capsular contracture. Rptr claims to have been diagnosed with the following after implantation: bladder/urinary chronic infections, low blood pressure, carpal tunnel syndrome, anxiety &/or depression, lack of concentration, mood swings, getting lost or confused, balance disturbances/vertigo/dizziness, atypical multiple sclerosis, elevated cholesterol or triglicerides dry eyes, thyroid problems, hashimoto's disease, raynaud's disease, esophagitis, duodenitis &/or gastritis, irritable bowel syndrome, hysterectomy, chronic vaginitis, hypersensitivity or allergies to molds, dust or pollen, unusual chronic infections, connective tissue disease, sjogren's syndrome, chronic swollen lymph nodes, lymphadenopathy under anus, sun sensitive, chronic fatigue syndrome, and clumsiness/drop things.


Rptr had initial breast implants placed following mastectomy for/ to prevent cancer. Rptr claims she has had the right implant replaced once. She has had two breast surgeries on the left, and four breast surgeries in the right; all beginning with the first implant surgery. Rptr does not have implants in now, does not know if calcium deposits occurred, and states that no biopsies were performed on tissue samples. Medical professionals have not confirmed silicone outside the breast scar tissue capsule. Rptr claims that the left heyer-shulte implant ruptured, and she had one capsular contracture. Rptr claims that the right heyer-shulte implant became a "painful contracture", and that this implant was "traveling from the original site, requiring removal". Rptr states that the dow corining implant was removed "intact", and that she suffered one capsular contracture. Rptr claims to have been diagnosed with the following after implantation: bladder/urinary chronic infections, low blood pressure, carpal tunnel syndrome, anxiety &/or depression, lack of concentration, mood swings, getting lost or confused, balance disturbances/vertigo/dizziness, atypical multiple sclerosis, elevated cholesterol or triglicerides dry eyes, thyroid problems, hashimoto's disease, raynaud's disease, esophagitis, duodenitis &/or gastritis, irritable bowel syndrome, hysterectomy, chronic vaginitis, hypersensitivity or allergies to molds, dust or pollen, unusual chronic infections, connective tissue disease, sjogren's syndrome, chronic swollen lymph nodes, lymphadenopathy under anus, sun sensitive, chronic fatigue syndrome, and clumsiness/drop things.

If you have a claim filed with Dow Corning Trust and need help with a deficiency notice or other letter from Dow Corning regarding your claim contact the Dow Corning Breast Implant Calim helpline today.

Attention Dow Corning Trust Claimants, Filings Before 1994

Written by lisaspitzer on . Posted in Breast Implant Blog

If you have filed a claim with Dow Corning Trust and need help with the complex settlement system we have lawyers who can help you at no cost to you. To be eligible for help you must be on the Dow Corning Trust settlement list and filed a claim and have a pending Dow Corning Trust Claim. If you have problems with your MDL-926 filing or your Dow Corning Trust Claim contact us immediately for help.

1994, Breast Implants Dow Corning Trust Claims Helpline


If you have filed a Breast implant claim prior to 1994 and need help with the Complexities of the Dow Trust or MDL-926 we can help you.

Our Breast Implant team can help with proof of Manufacturer, Disease determinations, and deficiencey notices. We are your source for making sense of a difficult maize of requirements. Our Breast implant lawyers have helped thousands of women. Contact us for help with your settlement claims;

MDL-926 Breast Implant Revised Settlement Program:

The Revised Settlement Program (RSP) permanently closed on 12/15/10. If your diesease claim was received by Claims Office  before the deadline and you receive a deficiency notice you will have one year from the letter date to correct the deficiency.

If you are a registered claimant of the MDL 926 and have filed prior to 12/15/10 and received a deficiency notice contact the Breast Implant Helpline. If yiu have submitted additional supporting documentation and received a denial in 2011 contact the Breast Implant Helpline.

If you are a registered claimant in the MDL 926 Revised Settlement Program, and have the following:

  • Already filed a Disease Claim prior to the 12/15/2010 deadline
  • Received a deficiency notice
  • Submitted additional supporting medical records prior to 12/15/2010
  • Received a denial in 2011

You have the right to appeal the Claims Offices' ruling within 45 days of notification of your denial.


Dow Settlement Facility -Dow Corning Trust and Your Silicone Breast Implants

On 09/06/01 The Settlement Facility – Dow Corning Trust (the "SF-DCT")  was  created to administer silicone gel and implant claims against Dow Corning. You may contact the SF-DCT toll-free at 1-866-874-6099 or (713) 874-6099. SF-DCT and the RSP Claims Office are two separate entities. However, this maize can become extremely confusing very quickly. If you do not have a breast implant lawyer to assist you contact the Breast Implant Helpline Today.

The Settlement Facility for the Dow Corning Trust (SF-DCT) is  processing class 5 claims. Class 7 claims have not been completed yet.

11,000 claimants have been approved for either an Expedited Release Payment of $600.00 or a Disease Cash-Out Offer of $3,000.00. Total payments to date from the Class 7 Fund are $15.5 million. The total fund is $57.5 million NPV.

The Settlement Facility is still reviewing Proof of Manufacturer Claims in Class 7 and is expected to complete all Proof of Manufacturer reviews within the next year.

A breast implant Lawyer can help You

  • Help you respond to your deficiency notice
  • Get  help with proof of manufacturer
  • Get help with proof of disease diagnosis
  • Help you with you Dow Corning Trust  and the Dow Corning Trust Settlement Facility requirements and interfacing
  • Help You with any of the Settlement trust office communications
  • Be your ally and confidant  and help you deal with the process of your Breast implant claim
  • Offer support and guidance
A settlement has been reached between the Claims Advisory Committee and Dow Corning which allows Notice of Intent (NOI) Claimants to have their claims for Explant, Rupture and Expedited Release processed and if, eligible, paid.  If a NOI claimant has already filed an Explant, Rupture or Expedited Release, they do not need to do anything to accept the NOI Settlement.
The SF-DCT has sent out an “Acceptance of NOI Settlement” form to all eligible NOI claimants.  You can also download a copy of this form on the Claimant Advisory Committee’s web site. If you want the SF-DCT to expedite the review and payment of your claim, you will need to complete the “Acceptance of NOI Settlement” form and mail it to the SF-DCT.  When the SF-DCT receives the form, they will review your claim, and if approved, will issue payment in accordance with the Consent Order and the Plan.
Relevant deadlines from the June 1, 2004 “Effective Date”
10 YEARS Deadline to file your Explantation Claim
(For implant removals after 12-31-90)
Deadline to file your Disease Claim and Increased Severity Claim
How long you will have from "NOS"
Deadlines from your receipt of "Notification of Status"
Time to provide Acceptable Proof of Manufacturer (POM)
for a Dow Corning implant (Class 5)
Time to provide Acceptable Proof of Manufacturer (POM) for a Bristol, Baxter, Bioplasty, CUI or Mentor implant (Class 7) when submitting a claim under the Silicone Gel Material Claimant Fund.
Deadline to cure "Deficiencies" in an Explant Claim.
Deadline to cure "Deficiencies" in a Disease


Breast implant Stories Collection, Breast implant Helpline

Written by lisaspitzer on . Posted in Dow Corning Breast Implant Stories and Sharing

At the Breast implant Helpline we are searching for stories to share. Our callers are suffering from diseases fro silicone breast implants and we do not want them to feel that they are alone. We found these on line and are sharing them with our readers

Rosie's Story
Breast Implants are in the news, but for tens of thousands of women, implants continue to raise questions that need to be answered.  I am one of those women. I had silicone gel breast implants following a mastectomy in 1982.
It was an uninformed choice. Like thousands of other women, I was not warned of any dangers surrounding breast implants, and was only told of the wonderful, new technology of today's world and how great I would look and feel following my mastectomy.
Since then, my health has been on a steady decline.
In stark contrast to what I was told by my doctors, I went through multiple surgeries due to complications with my implants including infections, tightened scar tissue, and broken implants. I had consulted with three different doctors before having implants and not one doctor warned me about any side effects or possible health risks. Nor did any doctor suggest it might be my implants causing my illnesses after I became sick. For many years, my doctors told me that nothing was wrong and I was led to believe that it was just my system or the flu causing my problems.

Over time, searching for physicians that would help me became a full time job and in 1993 I became totally disabled, losing my home, car, and many other things, due to the mounting medical bills.

Over those eleven years I underwent multiple surgeries that dealt with a number of problems, including incredibly painful breasts caused by scar tissue tightening around the implant, broken and leaking implants that were removed and replaced, infections, and lumps of silicone in my chest. I even tried the so called "new and safe" saline implants after intense urging from my doctor, only to have the right breast implant rupture and spontaneously deflate while I sat on the beach less then one year later.

All of this has caused me untold suffering, physically and mentally. Not only did I lose my health, but also I lost my career, my husband, and my home. The pain and anguish I suffer daily has caused my children great pain and concern. It has taken me almost 10 years of spending my own time and money on relentless research to find out the truth about the dangers of breast implants.
No woman should be made to sacrifice so much for the truth about her health. I would never have taken the chance had I known about the lack of safety data regarding breast implants. The more I have found out, the more angry I have become that women are still being told that breast implants do not pose serious risks to their health. Many others share my outrage, including Dr. Thomas Whalen, the chairman of the FDA advisory panel that recently voted to recommend approval of silicone gel breast implants.
Dr. Whalen has publicly urged the FDA to reject the advisory panel's recommendation because of the lack of evidence regarding silicone breast implants' long-term safety.
My life is an example of what silicone gel breast implants can do to women in the long-term. How often does this happen?  Nobody knows.  But I want to make sure women know that it can happen to any woman — even to them.  And I want the FDA will make sure that other women will not suffer the way my family or I have suffered.
Being a mother of three children, and grandmother of eight, who has multiple disabilities, I almost always find life challenging and unpredictable. But it is also quite adventurous and can still be quite satisfying. The people I've met while advocating and educating are wonderful, creative, caring, and loving people.
I believe that information gives us power, relieves stress, and can make us happier, healthier people. My personal health depends on my degree of willingness to accept my ever changing limitations and making the most out of what I can still do. My faith in God is my Salvation and sustains me everyday.

Gracie's Story

I want to thank all the women who help other women just beginning their journey here. It is because of and for these women I add my story to the many already here. They were a source of light for me and I hope the light continues to shine for all that come here.

At first, I thought what could I possibly write that hadn’t already been told. Flashback to the sixties. It was an era of uncertainty. It certainly was a time of uncertainty for me. I was a young, shy girl who was pretty by most standards. I was also flat as a pancake and very embarrassed because of it. My closest girlfriends were all amply endowed. The boys always seemed to notice them and not me. I felt unattractive and developed low self esteem. Big boobs were in. Next came the the liberation movement, the burning of bras and a boy that I became enamored with. I felt too inferior to even think he might have given me a second glance. I had a friend who suggested I see a PS and that perhaps he could help me. Young and naïve I made that appointment. It seemed like my problems had been solved. He could “fix me” and all would be fine. I was a 36AA pre-implant and he told me I would be a C post-op. So in 1974, I had breast augmentation.

I had my “friends” for almost 30 years. It was a love/hate relationship. The visual effects were excellent. I did have some firmness of the right implant, however, from the very beginning.I didn’t even think about it at the time. I was so happy to have gone from “flat to Fabulous”! I had no other real problems the first ten years or so. However, my right implant continued to harden and then there was the cold, the pain and burning. By 1993,things had gotten so bad that I couldn’t even sleep on my right side and I would walk around holding my right breast cupped in my hand. My family doctor sent me to a PS who diagnosed capsular contracture Grade 111.He advised continuing mammography and to come back for a yearly checkup. The following year I went to see him again and he told me “not to dwell “ on it. I went home that day in tears. Other things were not going so well either. In 1985 I had premature ovarian failure. I was finding it harder and harder to waitress as my back and joints began aching. I had been a healthy and athletic young girl and now I could barely get up in the morning and keep working. I was only 35! By 1993 I came down with chronic yeast and fungal infections. I had low grade fevers and began experiencing insomnia. In addition to these I also had night sweats, fatigue and intolerance to cold. I continued to try to support myself and carry on. By 1998 things had deteriorated even more and I went to another PS and made arrangements to have them removed. A week later I was informed my insurance would not cover the surgery. I canceled the procedure. Again in tears, I tried “not to dwell” on my circumstance. By now I was beginning to realize that something was very wrong and began to put all the pieces together. It was my implants causing this. I had no money . I also was newly married and had the implants when I met my husband. I had such low self esteem that I thought he wouldn’t love me without my boobs. Actually, I never let him touch them anyway as they were so tender and painful to the touch.
What good were they?!  Like so many other women, I wished now I had never got them. I was told they would last a lifetime. I’d spent the last 20 years regretting it.

Thanks to the love of a kind and wonderful husband, we made arrangements to have them removed in the spring of 2004. He said he loved me unconditionally and would be happy to see the things gone. So on March 15th of 2004 I had them removed in West Palm Beach by Dr. Luis Vinas. He removed them en-bloc and the surgery lasted 31/2 hours. He did a tremendous job considering what little he had to work with and managed to find every extra bit of tissue to raise and lift. I ended up a 36, small B. They are not the perfect round breasts of what I had before but I am utterly pleased with the new and real me. They were sent on to Dr. Blais in Ontario, Canada and upon further examination were revealed to be remarkable for gross bilateral ruptures predating removal by many years and for granulomata and severe calcification affecting periprosthetic tissue.

Fast forward to September of 2005 and it has been quite the journey of ones lifetime. My fatigue has almost disappeared and I still have joint pain as before but not as often and not always as bad. My rashes have all but disappeared Since my preparing for and having explantation I have lost around 25 pounds . I jokingly tell my husband I don’t mind being “flat but I’m not gonna be fat!” The reduction in weight has helped my self esteem and my physical well being. My husband is thrilled with the new me and loves to caress my real body. I continue to work on my health and well being and hope for more of my symptoms to abate. I would like to lose 20 more pounds but will do so in a healthy manner. I have adopted a whole foods diet but still enjoy forbidden foods once in while.I am going to take back my health or as much as I can. Since my E-Day I have come a long way. I was a young and pretty girl with no breasts and today I am happily back to a somewhat older version of what I once was in the early days with a few more scars to remind me of how lucky I really am. Thank God for a second chance at life and love. I’m not gonna mess it up this time around.

Wishing all the women here once again, the truly best at what life has to offer us in the genuine, real sense of the word. Thanks for listening to one more womans story. I hope it helps.


Barb's Story I was the skinny kid. The shy one who was teased a lot about her looks. Big brothers can be brutal. I did not develop as quickly as other girls my age, especially my twin sister. Even into adulthood I was teased about my small breasts (AA or A). I don’t know exactly when I started to think about implants but in 1980, at age 32, I decided to get silicone implants. I did not want large breasts, just some breasts. I thought it would boost my self esteem.

My implant surgery went without a hitch. Shortly after the surgery my husband and I realized how hard my breasts were. The doctor recommended massage which we were already doing but continued it in an effort to get them softer. About a year after my augmentation they were still quite hard. At this point my plastic surgeon recommended and did manual rupture of both capsules. Even with the pain killers and valium that was quite an experience. My breasts remained hard.

Over the next several years I enjoyed having my new B-cup size breasts and felt I looked better in clothes. I never completely adjusted to the artificially round look I had. Somewhere in the late 80’s to early 90’s I started having some health issues. Nothing serious, things like allergic reactions, multiple infections and widespread joint and muscle pain. In 1993, I saw a rheumatologist to see if my health issues may be related to my implants. All my blood work was normal at that time and he didn’t think my problems were because of the implants but said that no one would be able to tell for sure.

I settled into handling my symptoms as they came along. I started to refer to them as my “WEIRD SHIT.” Some of the symptoms I have experienced the last several years are:

Muscle Pain -Upper arms, neck, chest, upper back, thighs, buttocks
Joint Pain -hands, feet, toes, elbows
Pressure headaches
Ringing in ears
Sun sensitivity & rash; face, neck & upper chest
Intermittent tingling in legs, feet, arms, fingers, right upper back, neck and face
Many urinary tract and yeast infections
Burning lips, mouth, tongue
Dry eyes, nose, mouth, and vagina
Nausea, heartburn, constipation, diarrhea

In the spring 2001 I was feeling so sick my chiropractor suggested I see a neurologist. She found nothing in her examination, but blood work showed an abnormal ANA. I was referred to a rheumatologist who diagnosed me with systemic lupus and fibromyalgia. Over the next few years I saw 2 other rheumatologists who did not think I had lupus. Even though I had positive ANA, SM and SSA along with other criteria they felt that I did not have “true disease.”

About a year and a half ago I started having increased anxiety. My anxiety levels had increased after 9/11 and my continued health issues were part of the mess. I’ve been an anxious since childhood, but I learned how to handle it without anxiety medication. Things got so bad I needed to seek medical help for this. I told my therapist that I had forgotten how to trust my body and my fellow men. About the same time my intestinal issues got pretty bad. I have irritable bowel and a hiatal hernia with reflux. From last December until this spring I was so nauseated that I could not eat much. I lost almost 10lbs which is a lot for someone who is already thin. My primary care doctor ordered up scopes and scans and everything looked as expected; a hiatal hernia and IBS. My adult daughters were sick and tired of me being sick and tired. Almost every time I spoke to them they would say Mom, just get them out. I had previously decided I would remove them before I was 60. I am now 56 and have had my silicone implants for 25 years. At this point I thought that now may be the time to have them removed. My husband and family completely supported my decision.

I decided to share my implant and health story with my supervisor at work who is a nurse. She called in one of the other nurses who told me her story of having silicone implants and being very ill. She removed them a few years back and regained her health. The support and information from her gave me the boost I needed to begin my explant journey. I began to do research into removing them. Along the way I found explantation.com. What a Godsend, other women who had been through this process. What a great resource and a huge support this site has been for me in making my decision and helping me on my way back to health.

With many references from my nurse friends and my family physician, I tried to find a local plastic surgeon to do the surgery. I was dismayed at the responses from them or their staff. They told me things like:

***I would not be happy with how I looked if I did not reimplant

***That my husband would not be happy

***Just have a general surgeon do it if you do not want more implants ***If you are part of the class action lawsuit we will not help with any paperwork

Wow!!! What a bad name these kind of doctors give to other plastic surgeons. I was becoming quite angry.

I decided to go forth with the surgery and after much research chose Dr. Lu-Jean Feng, M.D. in Cleveland, Ohio. We left for Ohio from Michigan on Monday, September 26, 2005. The following day I had an ultrasound done just prior to the consultation. The radiologist, Dr. Leonard Kahn, said there was no silicone outside the capsules, but that they may be ruptured within the capsules. This was my first piece of great news. We then went to Dr. Feng’s for my consultation. My husband and I were impressed with her from the moment we met her. She spent about 2 hours with us going over all the details of the surgery and my complete medical history. I had brought a packet of information for her, including my medical history, a list of all my doctors, implant records and pre implant pictures. She said the information was very helpful, especially the pictures.

I was explanted the following day, September 28. We arrived at her clinic at 6:15a.m. and the surgery started at 7:00. Everything went well. She performed the explantation using the en bloc procedure. Dr. Feng did not think that I needed a lift because my implants were quite small (150cc). More great news as this meant less surgery. Since I had a history of getting sick from anesthesia they gave me something in the IV to prevent that from happening. It worked more great news.

When I awoke I saw my husband. What a beautiful sight. My left breast had some sharp pains but I could not feel anything on the right. I asked to see the implants and capsules. I thought they looked in good shape and not ruptured. After speaking with Dr. Feng she said they were both ruptured within the capsules. I stayed in recovery and we were able to leave around 11:30. I was amazed from the start with the lack of pain. I was uncomfortable from the drains, but never needed anything more than Tylenol and Arnica. I did not drain much and they were removed just over 48 hours after surgery. We drove back home to Michigan Friday afternoon. I was anxious on the ride home, being very protective of my breasts.

Each day I feel stronger, am able to do more with less discomfort. I look forward to continued progress and improvements in my health. I am now 1 ½ years post explant and continue to see improvements in my health.

I am a believer that things happen in our lives for a reason. I have grown from this experience. It has taught me that I am a strong and courageous woman. It has strengthened my faith in God, myself, my family, friends and fellow humans. It is my hope this story may help someone else in their journey from the ill effects of silicone implants.

Email Barb at barbvh1@comcast.net

Mervs Story


I was born with facial anomalies; cleft lip and cleft palate. And at several months of age, had several surgeries to correct most of the problems. At the age of 24 I was able to have more surgeries to complete the process, and to make my face more symmetrical. Part of the surgery included a silicone gel chin implant. And, I believe, silicon gel injections in my check. While the surgery itself was a huge success and changed my life for the better in many ways, I started having health problems about 2-3 years after that. I did not relate the chin implant with the surgery until about 5 years after the fact.

I want to say that I was picture perfect healthy before the implant, very physically active and had my plans for the future.

As the years went on, I was diagnosed with one health concern after another. My joke to myself was; New Year… new disease.

Subsequently, I lost everything, but with each loss, I also gained something in return. And in gaining, I found strengths and talents that I did not know I had, or was afraid to try before all my illness.

But I did not gently into the world of disabilities; I went cussing, kicking and screaming. I put up a hell of a fight before acceptance settled in.

I started to have health problems in 1988-89. In the mid 90's I started to explore the possibilities that the chin implant was the culprit. And I was explanted in '98, and replaced the silicon gel chin with titanium metal.

I spent about 10 years in rehab, and putting together a health regime that include holistic, natural and alternative methods of healing, as well as keeping up with my doctors of specializations.

About four and a half years ago, my health started to improve to the point where I could start thinking about a future. And at this point, I can work part time, have opened up my own business and am pursuing several projects that are in the creative realm, and thinking about going back to college to complete my degree that I walked away from way back when.

I am still on disability (collectively, it took 7 years to get it) and do not plan on getting off SSDI anytime soon, but I am actively working toward that goal… I can work enough now to ensure that I do not slip down the slippery slope of chronic disability and poverty. My business has grown and moving forward-as is the goal for all business. I am more financially stable and I have gone back to college. And I hope that within 5 years, I can make a substantial income for the future.

My health has also improved since the beginning of this year. I have been able to move up to a higher level of healing and better health-and it takes daily work to keep it that way.

I still have a ways to go, but am happy with where I am now (considering where I have been)I have major medical issues that I am still dealing with, and while that is frightening, the concerns at this point, are manageable.

I hope that others who have other kinds of implants can find comfort and hope and know that they are not alone in this.




Rosanne Averill's Story


"My name is Rosanne. I had my breast augmentation done with Dow silcone gel implants back in 1984. I was never told that I could develop any symptoms or suffer any ill effects of having breast implants other than a warning that if I didn`t massage them regularly that they could harden. Well I made sure I massaged them regularly and ended up very happy with the cosmetic result for a long time, or so it seemed. Even in the late 1980`s when I developed the autoimmune disease called Graves disease I never once thought it could be from the implants. Although everyone in my family including myself thought it very odd since I was always so healthy.

Then in the early 90's I started to develop some very odd flu-like symptoms that would come and go. My body would ache, I would get low grade fevers, my feet were extremly stiff, I couldn`t think. I felt foggy, my memory was poor and I was exhausted. Finally after a number of months went by I had a diagnosis of Chronic Fatigue Syndrone.

Since that time my life has not been the same.

It was around this time I was hearing that silicone breast implants could cause disease. I became very freightened and went to different doctors and was told by all of them that my implants were not causing me to be sick. I felt very reasurred by this.

In and around this time frame I became aware that I had a ruptured breast implant inside me. I new I had to do something but was so scared of going without any implants. After all, when they remove the implants they have to scrape the embedded silicone from your tissue which cause you to remove some of your own tissue. Hence I would be even smaller than when I started. I freaked out and made a foolish decision. I opted to remove the ruptured silicone implants and replace with saline implants. I did this in 1993.

My health has deteriorated as time has gone by. My fatigue has worsend, my vision has worsened , I have developed asthma, peripheral neuropathy, cognitive difficulties. I have difficulty with walking because my balance is off, my muscles are weak, I have had a diagnosis of mutiple sclerosis -like disease, I have developed migrane headaches, arthritis and for the past 3 years I have developed a severe tightness in my face and head which feels like my skin inside my head/face area is being stretched and pulled. This symptom is very painful to live with.

I have become totally disabled. The saline implants were removed almost 4 years ago.

I no longer care if I don`t have breasts. What is important to me is to help spread the word that silcone breast and saline breast implants can make human beings very ill. Silicone does not belong in the human body!"


Molly's Story


When I was barely a teenager, a doctor looked at my breast and told me they were 'deformed'. One breast was larger than the other. Needless to say, I was mortified. Years later, I finally decided to do something about it. At that time, I trusted doctors a lot more than I do now! I chose a doctor from the yellow pages, that claimed he was 'board certified' (he never was). I was 30 years old, divorced and the mother of a baby girl. I was thrilled with my new breasts, and for the first time in my life I looked good in clothes. I healed quickly, and felt great. At 32 I finished my degree in electrical engineering and started a new career.

Never did I once suspect there might be a problem. In 1991, I had numbness on one side of my body and a dx of 'probable MS' at Northwestern University. I certainly didn't consider it then – never even told the neurologist I had implants, because I did not consider it germane.

After working for years as an engineer, I decided to go to law school – an interest that I developed after my dad's death from mesothelioma (asbestos cancer). When he died, I read the Reports to the Senate Subcommittee on Asbestos Related Diseases. It changed my opinion of corporations forever – and for the first time, it dawned on me just how callous and greedy corporations can be, concerned only about the 'bottom line'. Little did I realize that it was not just my father that was used as a pawn by corporate greed…I had never considered the possibility that my implants would cause me problems! Talk about denial. When my mother sent me newspaper clippings in the 1990s about registering for the settlement, I threw them away! I was sure I was fine, and foolishly I never considered that I would ever need to have the implants removed.

Before I started law school, I had my first mammogram, at 46 years old. Looking back, I believe that is when the implants ruptured. Almost immediately thereafter, I developed rashes that itched and would not go away. I developed severe carpel tunnel, which I assumed was the result of excessive writing and computer work. And, I presumed the fatigue and pain was stress and the aches and pains of middle age. I assumed dizziness was due to overwork, and the vertigo I experienced was exhaustion.

My internist was not as optimistic. The month after I graduated, she called to tell me that I had Hashimoto's thyroiditis. She insisted I see a neurologist, rheumatologist, and endocronologist. I finally started the long process of seeing specialists, and having a multitude of tests – blood tests, MRIS (brain & cervical spine), and spinal tap. All were abnormal. Still, I never thought of my implants.

Through a homeowner association battle I tackled & won, I ended up doing some legal research for an attorney who was dealing with his own condo association. However, I was rapidly going downhill and becoming very depressed. In explaining why I could no longer work, I told him of some of my health problems – by then, I was being tested for multiple sclerosis and lupus, among other things. He asked me, over the phone, if I had silicone breast implants. I had not yet met him in person and I was floored at such a personal question. He explained he was also an MD, and had worked with litigation and settlement issues with implant cases. He asked me if I had told my doctor that I had breast implants. I had not. The next day I told my internist, and she immediately ordered an MRI. The MRI showed rupture – a 'linguini' sign. That was fall of 2003. By then, I had already been told I had peripheral neuropathy in all my extremities, carpel tunnel, Hashimoto's, MS and lupus. Every week it seemed something worse was happening. In February, I developed hives and went into anaphylactic shock, for no *apparent* reason. I feared I was going to die.

By the time I told my doctor I had implants, I was already very sick. In fact, she told me she saw me "deteriorate before [her] eyes". So when I told her, she immediately ordered an MRI. At the time, she said she didn't know if implants caused autoimmune problems. She told me of the reports that doctors read (that we all know say how safe implants are). Still, she kept an open mind. She wanted to find out what was wrong with me. After I had the explant, and she saw the lab report — the migrating silicone, chronic inflammation and the abnormal cells surrounding what was left of the implant — she no longer doubted. She told me that she did believe the implants were causing my illnesses.

To say I was desperate is an understatement. I had 'googled' implants, for the first time, and found Explantation.com, Implant~Info~Net and other helpful forums. Through the encouragement and compassion I received there, I began to realize that there was yet hope. I looked for surgeons in my area, and out of my area, and finally talked with Dr. Kolb in Atlanta. My internist and Dr. Kolb helped me with my insurance, that agreed to pay for a portion of the explant surgery. FInally, in April of 2004, I had an explant.

The attorney/MD (who had the audacity to ask me if I had implants) is retired from medicine and law, and has since been appointed by the governor to be the state 'condo ombudsman'. It sure sounds odd to say the condo ombudsman saved my life! He is helping me now with a settlement, as a late registrant for the implant settlement. I don't know if I will ever see a penny, but I do know that I have my life back.

It has been two years since my explant but it feels like a lifetime. At times I was sure I would never work again. But now, I am feeling better and working part time. For five years before my explant, I had consistently had high ANA, anti-Smith, RNP and SSA antibodies. Just recently, I had another blood test that was normal. I am beginning to feel that I have my life back. I am incredibly thankful for all the help and support I have received from the 'condo ombudsman', my husband, the women who have been through this ordeal before me, and my surgeon, Dr. Kolb.

Lisa Christine's Story

I had Silicone breast implants in 1987. Thinking it would complete me for I had never filled out,(developed) This period in my life was filled with many examples, Adult entertainment,the music industry, fashion magazines and of course my chosen field,(photography) was to be perfect.

After being implanted, I noticed how painful and sensitive my breasts had become all the time. Intimacy with my chest was look but dont touch,,it was too pain full.

I had my two children very close together, 15 months apart. I was told upon Implantation I could Breast feed with no problem, I tryed with my first son and could only handle 2 weeks for the pain was unbearable. I completely skipped any thought of breast feeding my second child.

As years went by, pain and sensitivity in my chest increased. Other symptoms started,terrible skin irritations, joint and bone pain, chills all over my body, dizzy spells, blurred vision, chronic fatigue, anxiety and depression.

Thank goodness for my family doctor for I have been with him for 7 years and with all my symptoms, He told me,"Get the implants out!!" your symptoms ARE implant related! It took me 1 more child and a couple years later and an MRI (both implants ruptured) to decide to explant.

After months of research, I found one of the best ex planting surgeons in the world, Dr Edward Melmed and was ex planted in 2007.

To date recovery has been hard physically and emotionally, I am unable to work, and sometimes feel I waited too long for explantation. I do have hope that I will get better and each day in itself is a blessing for me to be implant free.

If I had been told the truth, 20 years ago I would have never even considered this operation. It has affected the rest of my life and my family's to. I would not recommend this operation to any one ever ! Work on ourselves from the inside out,,,,not the outside in,,,it doesn't work.

Terri P.  Story

Hi everyone, My name is Terri P I am now back in Hawaii. I had my saline implants for 20 years.I was sick for 10 years before figuring it out. I had heard of the problems with silicone and even had been contacted by Dow about 15 years ago. I called my PS right away and he incorrectly told me that it didn't apply to me because my saline were completely safe. Sound familiar?

Anyway I heard a women on the news while I was doing dishes say her saline implants had made her sick. OMG I thought. That is when I went on the computer and looked up saline implants and sickness. Over 400,000 women who had the saline implants 20 years or more it said have been diagnosed with Fibromyalgia. I couldn't believe it. I had been sick 10 years!!!

I saw over 26 doctors and hospitals, but no one ever said a word about my implants. I listed it every time they asked on the form for previous surgerys. Not only that but I had capsular contraction on the right side that I had for 18 years. It was so hard and all the way up in my armpit. The PS again tried to pop it manually and then said don't worry it is just scar tissue.

I am now post explant, after going down another road from (Bleep). I had to move back in with my ex-husband because nobody else cared to help me and my children. I have two children. The good news is I live in Hawaii and feel better.

I didn't know about the whole detox thing so I haven't really started that yet. I gave up all meds. I couldn't remember who I was when I was at my sickest. Since explant, my memory is back and my fibro is better. I drink smoothies fresh fruit and am going to try a detox from all the toxins.

I am so glad that Rosie told me about you gals. We are in this together. I read other womens stories and I decided women don't need my tears — they need my strength.

I actually had DD breasts when I got my implants. Penthouse magazine offered me the money to get my implants so that my large breasts would look perky again instead of sagging. I was 25 and thought being a centerfold was everything a young girl could want.

I did the centerfold it was 1987.   Now I am 44 and my post explant breasts look just like they did before all this mess started except have scars and I am not skinny, but am overweight. But you know what? I still love myself and hope that if I can save one girl from getting those poision bags than all of this was worth it.
I am on my way to being better.
I have a new attitude.

Karens Story

I was 25 in 1981. I had been married a year to my high school sweetheart when I decided to get breast implants. I have never been happy with my AA cup size. I had a very curvaceous body but no boobs and I always felt unbalanced in my appearance. I had a girlfriend who was built just like me and we used to share our feelings about how we thought we got shortchanged. It was difficult to fill out bathing suits, and other clothing.

One day she told me that she had decided to get implants. We both grew up in Southern California where plastic surgery is a norm — "If you don't like it, fix it" mentality. Not to mention, my parents were both vain, and outward appearance was always an asset. Anyway, my friend ended up having surgery with a double lumen implant under her muscles. I saw what she looked like and how happy she was about her results. Also, my mom, who had always been flat-chested as well, had silicone injections into her breast when I was a teenager.

My husband liked my small breasts. He was not a "boob" man. There was never any pressure from him to alter my breast size. My hips yes, but that is a whole different issue. My husband's concern was that I would make myself too large. This was never my intent. I just wanted to look more balanced. I ended up going to a different plastic surgeon than my friend. I went with a surgitech smooth silicone surface implant around 275 cc's on top of the muscle and under the mammary glands. I wanted to have children and wanted to make sure I would still be able to breastfeed them. I knew a nurse who worked with my plastic surgeon who highly recommended him for his beautiful work.

I do remember the doctor asking me if I felt I should wait until after I had children to do the augmentation. I said no, that I really did not want to wait. I was going to do the surgery with local anesthesia only in his operating room to avoid the risk of a general anesthesia. My mom and mother-in-law supported me on my decision. I actually asked my Dad to borrow money for the procedure and he said no because he did not approve of putting a foreign object in my body. (Of the people I knew, he was the only one who had that insight.) So my mother-in-law loaned me the $ to get my augmentation. Afterwards, I paid her back monthly for her entire loan.

In November of 1981, I took a week off from work and had the procedure. I remember starting to cry when I was on the operating table. In looking back I think I instinctively knew that this wasn't a good thing to do; but it was too late as the doctor was cutting into me.

I had drains for a few days. I honestly don't remember the dressings. I do remember the doctor having me lay on my breasts in the recovery process and it hurt like HELL! I ended up being a full B cup. Just right for me at the time. I had capsular contraction on both breasts within the first 6 months. I remember the doctor would manually squeeze them to break up the scar tissue. I remember thinking that this was not what I had envisioned. Eventually the doctor said that it was not a good idea to do a closed capsulectemy as it could cause a rupture.

About 5 or 6 years after my breast augmentation, a lot of publicity was coming out about the Dow Corning products. I remember the talk show host Jenny Jones sharing her nightmares about her implant experience. My sister who was a nurse called me one day after watching a show about breast implants and said "sissy you need to get those out". I remember thinking, I have small children when would I deal with this. I went to have my breasts evaluated by the same surgeon who had done my friend's implants. He told me that the right breast was hardened to a 3 level and the left to a 2 level. He asked if I had any pain or other discomfort. I told him not really. His recommendation was to just leave them alone.

I have to mention, that I split up with my first husband in 1982. I married my second and current husband in 1985. We have 3 daughters. I nursed all three of them. Thank god it was not long after I got the implants. So I became part of the lawsuits against the manufacturers of implants. I didn't have any problems related to them. (Or so I thought) So I never claimed anything against them.

Life was very busy raising 3 girls close in age. During that time my younger brother died. I remember having a lot of fatigue but associated most of it to being a mom. My sister then passed away also at a young age. I was 39 and began to suffer from depression. I also relocated to a beach community and started having a lot of symptoms of chronic fatigue. Then I started having trouble with the top joints of my fingers. I saw rheumatologists who diagnosed me with osteoarthritis. My internist felt my fatigue was due to depression and allergies. Basically, I have had numerous blood panels and no markers show that I have rheumatoid arthritis. But, all the doctors agree that I have some unexplained inflammatory process going on. I have pretty severe arthritis in both shoulders. Moderate arthritis in both knees. Some arthritis in both feet. Every finger joint is disfigured due to arthritis. Over and over again, because I am proactive about my health, I have asked is there any possibility that these conditions are due to my implants? Not, one doctor felt that was the case. They said that they have found no proof of a connection between silicone and these conditions. My internist said that I would be very distraught if I were to remove them as I would be disfigured!

I have been getting regular mammograms since I have had my implants. They have always used special placement of my breasts because of the implants. Every time I have a mammogram they would ask me how old my implants were. This last time, in December of 2008, the technician had me sign a waiver due to the possibility of a rupture in the implants due to the procedure. My instincts were saying in a small voice "don't have one". But I did. I felt a pain worse than usual during the mammogram on my right breast. Shorty afterwards, I felt a lump on my right breast near the areola. I had tenderness and pain near the armpit on my right breast as well. I also felt a tiny sore spot on my left breast. Well, it was holiday time. I was due for my period and I had just changed my hormone patch to a higher level. This is how I procrastinated on dealing with it.

In January, we had a re-decorating project going on in the kitchen. Then in February, I had to take care of my mom after a surgery. Finally, in mid-February I asked my husband to see if he felt something odd. Yes he did, and how long has that been there you need to get it checked out. So I went to my ob/gyn. She felt it was above the implant. I had an ultrasound. The radiologist came in and said I think that your implants may have leaks. He was fairly certain that it was not cancer. Then I had an MRI with contrast which showed an intracapsular leak in the right breasts. I had consultations with 3 different surgeons. All 3 said to not wait long to fix this. The implants needed to be removed. I made my decision, and I went with the doctor who would do less cutting. A doctor who was not intimidated by my questions. He was also aware that for all the research against the connection with health issues and implants; there are women who do have issues and no one can deny that. I would never want to deal with implants again, saline or silicone. At least they now tell you that they will last 10 years tops before there will be a rupture. So, it turns out that both my implants were taken out in one piece; however, the right implant had a posterior extra capsular rupture This may explain all the shoulder issues! The left breast implant was also ruptured inside the capsule. When evaluated by the surgeon before explantation, my right breast hardness was at a 4 level and my left at a 3.
He said that the capsules were very hard. He was able to clean out all the silicone on the outside of my capsule.

What I don't understand, is how can a doctor recommend a mammogram, and not an MRI knowing that I had implants in me that were 27 years old!

My surgery went well. I am recovering nicely. I feel confident that I will look attractive enough with my new boobs. My husband, family and friends have been very supportive. I'm looking forward to more healing, detoxing, supporting others, and accepting myself as God made me!

(Here is the photo my surgeon took of my explanted beasts on 4-27-09 The right one was very calcified thus appears more opague)

Karen Curry's Story

Karens' ruptured 1985/Bristol Meyers/Surgitek implants. Then read her heartbreaking story below (website under construction)  Pictures will be here shortly.Upon having a Bilateral Mastectomy, I was reconstructed with Silicone Gel Breast Implants. I had them for twelve and a half years. They were the largest on the market, 800 cc's a piece. Both ruptured. Right one was fragmented (dissolving). Right Capsule Ruptured, forming a secondary capsule in upper right abdomen. A lot of spillage during explant surgery. A lot of migration prior to surgery. All was retrieved with exception of a little over 200 cc's of silicone gel. Though they were removed eight years ago. I still to this day, show crystals when I do a spit test or sneeze and when I cough up phlegm, it never dries but remains as an oily substance.

My health has been on a steady decline since 1988, three years after I was reconstructed.

1. 1983 – Underwent a Bilateral Mastectomy.

2. 1985 – Reconstructed with Silicone Gel Breast Implants.

3. 1986 – Hardening of the right Breast Implant and underwent a Closed Capsulotomy.

4. 1987 – Hardening again of the right Breast Implant and underwent a Closed Capsulotomy in October and November to no avail. In December of 1987 the Plastic Surgeon gave me a Cortisone shot and tried the Closed Capsulotomy again, but again, to no avail. So the Doctor instructed me to take 4000 I.U. of Vitamin E a day and follow up in one month for another Closed Capsulotomy. Which did not take place due to illness.

5. 1988 – Diagnosed with Benign Multiple Sclerosis; Vaginal Anesthesia; Symptomatic Gastroesophageal Reflux.

6. 1994 – Diagnosed with Atypical Connective Disease/Atypical Rheumatic Syndrome/Non-Specific Autoimmune Condition Disease with Impressive Neurologic Abnormalities.

7. 1997 – Left Breast Capsule had a Class III Capsular Contracture. Right Breast was quite firm and misshapen with loss of medial fullness. Class IV Capsular Contracture on Right Breast. Bulge of 4-5 cm beneath Inframammary Fold. Ruptured Capsule, with secondary Capsule forming in Upper Right Abdomen.

8. 1997 – Explantation of Both Ruptured and Fragmented Implants, including Capsules.

9. 1997-1998 – Diagnosed with Fibromyalgia; Connective Tissue Disease and Chronic Fatigue.

10. 2001 – Degenerative Disc Disease of the Cervical Spine with spinal stenosis and flattening of the anterior Spinal Cord, causing Bilateral Neural Foraminal Narrowing. Including disk protrusion, causing left cord compression.

11. 2001 – Per MRI, spots were found in the frontalparietal white matter with areas representing demyelination.

12. 2001 – Diagnosis of Osteoporosis of the Lumbar Spine and Breast Implant Syndrome.

13. 2003 – Diagnosis of Hiatal Hernia.

14. 2005 – Per MRI and MRA, Diagnosis of Multiple Sclerosis; Cerebral Atheroscierotic Vascular Disease; Peripheral Neuropathy; Anemia; Including Hyperintensity of the tip of the Basilar Artery which appears to be a focal Aneurysm.

I do not believe it's plaque build up in the Blood Vessels and Arteries of my brain. I believe it's Silicone. It's been noted that Migrating Silicone not only spreads to all the vital organs, but also passes the Placental Barrier and Brain Barrier.

But does it matter now? No! They've informed me the Aneurysm is in an inoperative area and they cannot remove the "Plaque" build up from the Arteries of my brain. They can only treat the symptoms.

I'm on Disability. My family has turned their back on me and the only friends I have are the ladies in my Support Group.

So, if anyone who reads this thinks this is all hog-wash, then please don't let anything I've said deter you. You get your breast implants, enjoy your life and be happy. 'Cause I too had a life once. I had a career, making good money, love of family and friends, a drop-dead figure, a wonderful husband, my health, active in Church, School and Community and in love with life.

But now it's all gone, including my husband who died from the causes of Agent Orange (another chemical Dow made) after having just turned 54.

Even though I had a Bilateral Mastectomy, if I had read 20 years ago what I just wrote, I would never have allowed that toxic garbage to be placed in my body. And if you still think they're healthy, then please take another look at what was removed from my chest.

Which by the way, the implants of today are not any better. They are still made from Toxic Chemicals and they are still called Silicone Breast Implants.

Karen L. Curry or know as "Snowdove" on our forum


Gretchens Story

Six months before I got breast implants. I was doing fitness competitions and I was one of the few competitors that hadn't had plastic surgery, so I didn't think anything bad could happen.
At my worst, in February 2007, I could barely walk, talk, think, move or see. I never came across a site like this when I was thinking of getting breast implants and I want to share what I learned the hard way about the risks that come along with wanting bigger breasts.

If I'd known that there was a possibility that I could lose my stamina, memory, have a seizure, be in a coma and be very sick for an year, I would've never risked it.

I paid over $7,000 to receive "safe" breast implants on December 26th, 2006.   I immediately got very sick and since then have had 2 more surgeries to remove the implants and remaining scar tissue.   Almost one year later, am still struggling with various symptoms and have spent over $20,000 in medical expenses trying to get well.

No doctor could diagnose me and I had to figure out what was wrong on my own by finding sites like this from other women who had been affected by saline and silicone implants.

Breast augmentation is a huge trend among girls and women in the United States right now. Now you know that someone who also thought this could never happen to them or anyone they knew – got very sick, almost dying in the pursuit of physical perfection.

I hope you take the time to read my story and share this information with anyone you know who may benefit from it. Please contact me here if you are experiencing problems, have questions or would like to talk.


BJ's Story* Blood test ~ Platinum is in the free highly oxidizing form

* Blood Test ~ Silicone Toxicity ~ * Allergy test ~ allergic to everything

* I have Severe Multiple Chemical Sensitivity in small amounts of everyday chemicals

* 1984 Silicone breast implants, next day low fever, 4 to 5 months of antibiotics, Surgitek single-lumen adjustable silicone-gel and saline

* 1985 D&C , went into my change age 45 ~ started putting on weight slowly Arthritis ~ Memory ~ Headaches

*1986/87 Loss of smell ~ very little taste ~ Short term memory, pen and paper in every room

* 1985/86/87 Closed capsulotomys

* 1986 Hemotoma

* 1993 Silicone rupture, replaced with Saline in August, itching and burning ever since, ~ Open capsulotomie both breast, 12/23/1993, culture serous type fluid inflammatory in nature ~ Epstine Barr Virus ~ Lung x-ray pleural thickening and calcification reduction of lung volume ~ Right lung aspiration, reaction to Demerol, Narcan twice ~ Rare Fibrous tissue, Rare Foamy Histiocyte fill the apex of the right upper lobe ~ Videopelviscopy, Chronic lower abdominal pelvic pain, menses for 70 some days out of 85/90 days ~ Spastic bowel.

* 1993/1999 MRI Brain, sinus disease right

* 1994 Connective tissue disease, positive ~ Organic brain syndrome with cognitive impairment ~ Atypical Neurocogic disease ~ Multiple Sclerosis like syndrome ~ Tooth Broke

* 1995 Silicone Antibody ~ Tooth Broke

* 1996 Spasms of Esophnagus, endoscopy and dilation twice ~ Sleeping spells 18 to 21 hours, 3 to 5 days at a time, 3 to 4 times a month ~ reaction to all the medication ~ Gastritis

* 1996 Total disability, retrograded back to 1993, impairments considered to be severe under Social Security act are silicone breast implant rupture and silicone toxicity

* 1997 Emphysema ~ Tooth Broke

* 1998 MRI right shoulder, tearing of the supraspinatus tendon ~ MRI left shoulder, fluid in joint.

* 1998 Allergy test, allergic to everything

* 1999 Brain Spect scan, abnormal ~ Toxic encepholopathy ~ Dry eye syndrome ~ Chronic rhinitis, sinusitis and laryngitis ~ Vestibular disorder peripheral with vertigo ~ Immune dysfunction and autoimmune disorder ~ Multiple Chemical Sensitivity, in small amount of everyday chemicals ~ Tryptase level below normal ~ Abnormal neurological examination ~ Pulmonary function low normal range ~ Elevated thyroid antibodies ~ ATOVA test, abnormal ~ Micro Cog, low average ~ Cholesterol high ~ 3mmm punch biopsy, viral exanthems and drug eruption ~ Abnormalities were detected, T and B cells ~ IgG Benzene Ring, high

* 2000 MRI, left partially deflated saline implant ~ Blood test, markers for Sclerosis ~ Lupus ~ Sicca Syndrome

* 2002 Platinum oxdizing form ~ Thyroid nodule ~ Thyroid, of Hashimotos nature ~ Tooth Broke

* 2005 MRI Spine – Cervical – Thoracic – Lumbar, Degenerative disc disease, disc dessication, spurring, spine canal stenosis, degenerative spondylosis ~ MRI Right & Left Shoulder.. (Both) Severe degeneration & osteoarthritis at the AC joint, (Both) tearing of the Supraspinatus tendon, (Both) partial tearing of the Infraspinatus tendon ~ Thyroid Ultrasound.. left nodule increase in size, there is heterogeneous signal.

Severe reactions,
life threatening, pesticides, albuteral, demerol, carmex, white diamonds, pinesol, 409. Others things that cause reactions ~ aspirin, novocain, dental gas, cortisone, predisone, oil of olay, mary kay, jergens lotion, new skin, sara michales, fressia, opium, black pearls, stetson, old spice, mennens, clairol herbal essence products, body washes, hair spray, deodorant, shower shine, fabreeze, scrubbing bubbles, loc, wd40, some paint, carpet shampoo, calvin klein 1, armirage and more.

Side affects,
all affect the central nervous system for me, affects lungs, throat constricted, walking ability, whole body shaking, loss of voice 5 to 19 hours at a time, lose muscle control, whole body immobile, short term memory, slurred speech, vertigo, headaches, blurred vision, chest pains, hands and feet swell, affect kidneys, feet flipping out of control. Different chemicals cause everything in the body to flip and flop.

* * Medicare won't pay for what I need, controlled out-patient surgery center, a place for recovery, test for anesthetic, antibiotics, different chemicals, what people wear cosmetic, perfume, shampoo, bath & hand soap, cleaning products in and out of surgery, the list goes on. * * I am classed as high risk. I am denied surgery do to MCS

* * My only medication, vitamins, minerals, herbs, essential oils, gamma globulin, B-12 & B complex shots, as I have a reaction to medicine /chemicals

There are many horror stories from Silicone Breast Implants and s many dangerous drugs and medical devices that harm women. The Vaginal mesh is the latest in implants that are having disasterous complications for women. See  Vaginalmeshhelpline.com. Other horror stories come from yaz , yasmin, Mirena IUD and others. If you have a story to share contact  one of the helplines today.

November, 2006

The US Government's Food and Drug Administration has caved-in to the Breast Implant Industry by giving the billion dollar safety approval to silicone gel breast implants.

The Humantics Foundation and Ilena Rosenthal's opinion on this ill advised decision mirrors the views so well expressed here by:

    Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group
    Silicone gel breast implants most defective medical device ever approved by the FDA
    Excerpt: The approval makes a mockery of the legal standard that requires “reasonable assurance of safety.”
    Kim Gandy, President of NOW;
    FDA Approval of Dangerous Implants Follows FDA Pattern of Favoring Money and Politics Over Science

    "It is impossible for women to give informed consent for implants if the information they are receiving is inaccurate or incomplete," said Gandy. "The very real possibility that women and their children will be exposed to grave health risks is a serious matter. The FDA made an unconscionable move …"

    Gandy concluded: "The FDA has never rescinded approval for a medical device after it has been approved, but that's not going to stop NOW from trying. When the new Congress takes office we will petition our representatives to initiate an immediate review of the FDA and this dreadful, dangerous decision."
    & Dr. Diana Zuckerman, President, National Research Center for Women & Families, quoted in Forbes here:

    The FDA's decision to approve silicone gel breast implants is a triumph of corporate lobbying and hype over sound science and women's health. The FDA's standards for implants have reached a new low with this decision.

Please click here to send a message to your Member of Congress. Let them know you believe the FDA MUST Thoroughly Examine Safety Evidence & Must Stop Ignoring Evidence of the dangers of silicone breast implants

A Medical Social Worker Speaks on DOW Claims Filed Before 1994

Written by lisaspitzer on . Posted in Dow Corning Breast Implant Stories and Sharing

 Breast Implant claims Helpline is  for women in the U.S. who have filed MDL-926 claims, or Dow Trust settlement facility breast implant claims before 1994 and are registered with Dow Corning  and have diseases from silicone breast Implants. Diseases from silicone toxicity and disfigurement from the breast implant are a huge portion of the claims filed. To be part of this litigation you must have filed a claim.

"As  female Medical social worker I am extemely concerned about the Breast Implant Claimants and the  diseases faulty implants have effected  both the Medical and Psychological  wel being of women." Call us to  learn  about your rights under the Dow and other manufacturers  claimant trusts and the MDL- 926. We have female breast Implant lawyers ready to help you. Again you must have filed a claim with proof of muanufacturer and a disease diagnosis.

Psychological Effects of faulty Breast Implants can  last many years

Any dramatic life change impacts your body on a physical, emotional and psychological level. Breast implant surgery takes a huge amount of trust in the doctor. Breast implants gone wrong has severe psychological ramifications especially when you consider how the desire for a better physical appearence has resulted in disease or deformity. Many women who choose breast implantation are very happy with the results of their surgery. They report psychological and emotional benefits from their new found body image. However, many women report side-effects and feel that their short-term and long-term health has been compromised. When breast implants rupture the leaking silicone can cause severe immune deficiency dieases such as Lupus. This is causes additonal trauma to the emotional and physical health of the implanted female.

Emotional and psychological trauma is the result of extraordinarily stressful events that shatter your sense of security, making you feel helpless and vulnerable in a dangerous world. The awareness of having something dangerous put into your body that may rupture or cause asever debiltiating disease, in my opinion, is emotional and Psychological trauma.                                                                         
Since many studies suggest that cosmetic surgery in general leads to immediate post-operative improvements in body image, quality of life and depressive symptoms then what does breast implant failure with severe side effects lead to? I would suggest a feeling of vulnerability and depression.If Breast implants boost self-esteem for many women then finding out that breast implants come with severe warnings and silicone causes immune system dysfunctions and toxiciity would certainly make women feel " let down." and tricked by docotors into believing they were doing something that would enhance their lifestyle and self image.

Physicians at Massachusetts General Hospital in Charlestown, using magnetic resonance imaging, found that a significant amount of free siliconehad migrated from an implant (not noticeably ruptured) into the liver and spleen of a woman. (Magnetic Resonance Medicine 36:3 [September 1996], 498-501. Researchers also found that silicone in the liver could be detected in the first three to four years after a woman received her implant. (Magnetic Resonance Medicine 33:1[January 1995], 8-17.) With this type of information all over the internet having implanted Breast Implants would certainly make one quite nervous, especially when symptoms are starting to develope. Now, if you read about bad side effects from a medication or cosmetic product well, you can just stop using the product. But these implants are inside  a womens  body.  They are violating her  and no one ever told her or gave her the information until they were inside. This is not a car part. This is her body. It is not uncommon for wome to feel violated ,very similiar to a rape victim. In this case they were raped by manufacturers.

A Breast Implant Story

I was at work and I started getting dizzy and couldn't focus on simple tasks. Everyone said I seemed very depressed and withdrawn.  Most people assured me that it was just part of recovery or anxiety and I would feel like myself in no time. I KNEW something else was wrong – I just kept telling people I didn't feel like myself.  I started losing my memory among other terrible things. Over the course of this illness, my symptoms have included:

  •         Very blurry and sometimes crossed and foggy vision
  •         Trouble reading or retaining any information
  •         Couldn’t drive or walk around my apartment without getting lost
  •         Couldn't remember who I was sometimes or who my parents or friends were
  •         Nothing was ever familiar and I couldn't recognize my face or name when I saw it or heard it/ This is described as "brain fog"
  •         Couldn't figure out how to wash a dish or dry my hair
  •         Couldn’t watch TV or listen to music because I felt confused and out of it
  •         Didn't understand much of anything people said to me
  •         Tingling hands, pain in my body, extreme fatigue, dizziness & the room always spinning
  •         Muscle and joint pain in my arms, back and legs
  •         Felt like I was falling all the time
  •         Extreme anxiety and depression
  •         Skin rashes, especially on my chest
  •         Hair loss
  •         Night disturbances and sweats with extreme thirst and dry eyes
  •         Burning, dry itchy skin
  •         Tremors, muscle twitching and jerking, body shaking, and heart palpitations
  •         Extreme fatigue

Psychological and Emotional  Effects of Breast Surgery
There are many reasons people have breast surgery. Many of these reasons have an emotional basis to them

  •     To improve self esteem
  •     To replace a breast removed because of cancer
  •     To correct asymmetry or deformities of breasts
  •     To get positive reinforcement from a loved one
  •     To build self confidence about their bodies

But Silicone  Breast Implants somehow it just did not turn out that way

Living in fear with a “ticking time-bomb” in your chest after  discovering you have potentially dangerous breast implants which could leak toxic chemicals is a frightening experience. This is not a recalled car part, these have been implanted into your body. This is a part of your body threat will be important in birth and feeding a new born. This has severe emotional and psychological repercussions. The breast is a very important part of the birth process. Many women with breast implants can breast-feed, but in some cases breast implants may interfere with breast-feeding. If this is true, then what is the effects of a ruptured silicone leaking breast impant on a newborn and what kind of emotional reaction does the mother of this newborn have. It has been suggested that children born to, and breast-fed by, mothers with silicone breast implants might be adversely affected by transmammary or transplacental delivery of silicone during either breast feeding or pregnancy. Silicone might be available for transmission since periprosthetic breast tissue, regional lymph nodes, and possibly more distant sites in such women are exposed to silicone fluid by gel fluid diffusion, to silicone gel in cases of implant rupture, and to silicone elastomer from implant shells.

Many teenagers and young adult women have gotten silicone breast implants to enhance their appearance and improve their social lives as well as feel better amongst their peers. I am reminded of this quote "There is no agony like bearing an untold story inside of you." ~ Maya Angelou. For a young woman at the prime of life having a dream shattered by disease and toxicity is life changing psychological experience with long term repercussions.  " Who am i now" "what will become of me"" Will I ever be beautiful again" are the questions internalized. Thousands of women  were disfigured by dangerous Breast implants. Many of them are teenagers and young women and are still feeling the emotional and physical scars today.

For a teenager this is very frightening and has long term psychological effects.Two of the most popular and controversial cosmetic procedures for adolescents are liposuction and breast implants.  Being a teenager and finding out you have dangerous breast implants can have long term psychological effects.  Teenagers are not mature adults and do not have superior coping skills.

                                                                                                                                                                                                                        For women who have struggled through breast cancer, choosing augmentation and reconstructive surgery with breast implants is a way to regain self-esteem and a feeling of normalcy.For breast cancer victims the thought of having survived Breast cancer and then having to deal with dangerous faulty breast implants can be both depressing and shattering to hope for their future and survival. THOUSANDS of cancer survivors  were placed at risk after it emerged they may have been fitted with faulty implants to rebuild their breasts.

Breast cancer survivors are weak with poor immune systems. Both populations are are not equipped emotionally to deal with a dangerous implant being placed into their bodies. For breast cancer victims the thought of having survived Breast cancer and then having to deal with dangerous faulty breast impalnts can be both depressing and shattering to hope for ones future and survival.

In 1956, silicone fluid injected into laboratory dogs migrated to all the major organs; and in 1961, the year the first implants were released, Dowís own internal medical research department reported that silicone leaking from implants is equivalent in toxic effect to direct injections of silicone into the body. Can you imagine a woman with silicone Breast Implants hearing this?

Another  Silicone Breast Implant story

About a year and a half later, I started feeling like I had the flu constantly. I was calling in sick to work and going to the doctor often. I did the best I could at work, where I worked as a graphic designer, and tried to ignore the way I was feeling. I started having extreme fatigue where I would fall asleep at work and some days, couldn't even get out of bed. When I was awake, I was very dizzy and too much activity would cause me to pass out. I was put through all the tests and was diagnosed with depression. I saw a psychologist once a week and was put on two anti-depressants and an anxiety medication. I just got worse and worse and ended up taking a leave of absence from work. I laid in bed every day and cried. I was distraught and suicidal. A member of my family was with me almost all the time taking care of me. I could not function. Eventually, because I was so medicated, I managed to go back to work. I couldn't focus or think and I could barely read. At this time, I was still blaming all of my symptoms of illness on depression, because that was the only diagnosis I had gotten. It was a daily struggle to do my best to concentrate with this fog in my head. I was constantly sick, taking days off for flu or sinus infections. It was so hard not being able to tell my employer why I was so sick all the time, because I really didn't know myself. Then the pain started. My joints, muscles and bones ached all over my body. I started having significant memory loss which greatly affected my work. Soon, working was no longer an option.

I continued to get worse. I couldn't drive, read or do anything that required focus and my body was racked with constant pain. Sometimes, I couldn't even hold a conversation. All I could do was lie in bed every day and wonder if I was going to live through this. For a while, I didn't think I would. This is just one of many horror stories. The side effects can lead to long term depression.

 Sidney Wolfe, Director of Public Citizen’s Health Research Group
Silicone gel breast implants most defective medical device ever approved by the FDA
Excerpt: The approval makes a mockery of the legal standard that requires “reasonable assurance of safety.”
Kim Gandy, President of NOW;
FDA Approval of Dangerous Implants Follows FDA Pattern of Favoring Money and Politics Over Science

"It is impossible for women to give informed consent for implants if the information they are receiving is inaccurate or incomplete," said Gandy. "The very real possibility that women and their children will be exposed to grave health risks is a serious matter. The FDA made an unconscionable move …"

Gandy concluded: "The FDA has never rescinded approval for a medical device after it has been approved, but that's not going to stop NOW from trying. When the new Congress takes office we will petition our representatives to initiate an immediate review of the FDA and this dreadful, dangerous decision."
& Dr. Diana Zuckerman, President, National Research Center for Women & Families, quoted in Forbes here:

The FDA's decision to approve silicone gel breast implants is a triumph of corporate lobbying and hype over sound science and women's health. The FDA's standards for implants have reached a new low with this decision.

The breast Implant fiasco wrecked havoc on the lives of thousands of women both physically and emotionally. If you are a victim of the  silicone breast Implants and have filed a claim and meet the filing and disease criteria contact us  and Speak to a female medical social worker today. Our lawyers are concerned and sensitive to your issues. Please remeber you must have filed a claim to be part of the class action settlement programs.

Breast Implant Claims Helpline NYC, Breast Implant Lawyers

Written by lisaspitzer on . Posted in Breast Implant Blog

Breast Implant Claim Helpline NYC and Breast Implant lawyers are here to help you with deficiency claims, proof of disease, proof of manufacturers and breast Implant Manufacturer claims in Manhatten , Queens, Brooklyn, Bronx, Staten island, Long Island, White Plains and Westchester and Rockland Counties N.Y and N.Y,C. You must be registered with Dow Corning and filed a claim.

Silicone breast Implant Complications- Do You Have these Symptoms or diseases for Silicone Breast Implants ?

  •     Breast Pain
  •     Upper and Lower Back Pain
  •     dry eyes
  •     joint pain and swelling
  •     myalgias
  •     chronic fatigue
  •     Lupus
  •     numbness and tingling in extremities
  •     photosensitivity
  •     Chemical Sensitivities
  •     Muscle Pain, Stiffness, Unusual Fatigue
  •     Excessive Hair Loss
  •     Achy or Swollen Joints
  •     Extreme fatigue
  •     Skin Rashes
  •     Rheumatoid Arthritis
  •     Polymyositis-Dermatomyositis
  •     Mixed Connective Tissue Disease
  •     Scleroderma
  •     Sjogren's syndrome
  •     Anemia
  •     Sensitivity to Sunlight
  •     Kidney Problems
  •     Fever
  •     Difficulty Swallowing or Breathing

Breast Implant complications may be serious. You must see a physician immediately.

Symptoms of Lupus

  • Fatigue and fever
  • Joint pain, stiffness and swelling
  • Butterfly-shaped rash on the face that covers the cheeks and bridge of the nose
  • Skin lesions that appear or worsen with sun exposure
  • Fingers and toes that turn white or blue when exposed to cold or during stressful periods (Raynaud's phenomenon)
  • Shortness of breath
  • Chest pain
  • Dry eyes
  • Headaches, confusion, memory loss

 If you were inserted with silicone breast Implants before June 1, 1993, you may be eligible to participate in the Dow Corning (SF-DCT) and/or MDL 926 Class Action settlements.Call the breast implant Helpline and speak to a Breast Implant lawyer.

Your Breast Implant Lawyer will need to Know

  • Approximate date of initial implantation and at what facility?
  • Who was the doctor that performed the procedure?
  • Brand of Implant(s)?  
  • Do you have a copy of your medical records from your breast implant surgery?
  • Have you had your implants removed?
  • Do you have proof of Manufacturer ?
  • Do you have medical disease reports from a physician ?  
  • Are/were your implants ruptured?
  • Have you registered with either of the Claims Office? Which one(s)?
  • Have you filed a Medical/Disease Claim? SLE, dry eyes, joint pain and swelling, body and face rashes, myalgias, chronic fatigue, numbness and tingling in extremities, photosensitivity,? 
  • Are you currently being treated by a doctor or a specialist?
  • Have you received money from either Breast Implant Litigation Settlement Fund?

Breast Implant Helpline , tests for Silicone Poisoning

Written by lisaspitzer on . Posted in Breast Implant Blog

Breast Implant Helpline and  Our Breast Implant Lawyers are helping women with silicone breast Implants. Silicone Toxicity has been a serious complication from breast implants.

Tests for silicone poisoning

The most sensitive test available in this country to assess the reaction of white cells to silicone in the body is a lymphocyte chemical sensitivity (silicone) test. This just involves sending a blood sample to ACUMEN. This test does not tell us about the total load of silicone but whether or not the immune system has been activated agasint silicone.The worst affected women have the highest levels of sensitivity.

Dow did the first tests for Silicone Toxicity

One of the first (if not the first) systematic evaluations of the toxicology of commercial silicones was conducted during World War II at the Dow Chemical Company. Silicone intermediates (chlorosilanes and ethoxysilanes) and selected commercial silicones were tested in rats, rabbits, and guinea pigs. The chlorosilanes and some ethoxysilanes were found to be highly corrosive; they represented significant industrial handling hazards. Methyl-and mixed methyl-and phenylpolysiloxanes, on the other hand, had very low toxicity. For practical purposes, they were divided into three groups: fluids, compounds, and resins.

A Doctors Point of View

A. Women with side effects from breast implants often get hopeless prognoses from doctors, or else get treated as if their problems were imaginary. Medical literature does not support the existence of silicone disease, but it is obvious to me that women who have had silicone in their bodies may suffer from a variety of autoimmune reactions. The Food and Drug Administration put a halt to silicone implants in 1992 because of concerns about their safety.

I don't think it's a great idea to have silicone in the body, so if you've experienced any problems I'd have the breast implants removed. It's a tougher question if you're not having problems. If the implants are undamaged and intact, you're probably OK – and it may not be worth the trauma to have them removed. On the other hand, the implants can develop slow leaks, with complications showing up later. One sign of a problem is if your breast becomes hard. An FDA panel estimated in 1992 that up to 6 percent of silicone implants rupture. If you're unsure – or just concerned – about the status of your implants, talk to your doctor; he or she can detect abnormalities by ultrasound mammography.

About four out of five women receive implants for cosmetic reasons, while the remainder are implanted for reconstruction after breast cancer surgery. Breast enhancement is one of the most popular forms of plastic surgery in North America.


Saline Implants Cause Illness

The use of silicone gel filled implants was restricted in the early 1990's when the manufacturer's couldn't prove they were safe. This was after thousands of women, sometimes called "silicone women," had become ill from being implanted. Saline filled implants, considered a "safe" alternative, became the only type widely available in the US. Doctors are seeing cases where the saline becomes contaminated with bacteria, creating health problems. Also causing serious health problems is the silicone shell that cases all saline filled implants, making a whole new generation of "silicone women."

Symptoms of Silicone Illness

Typical symptoms associated with silicone illness (also called "silicone poisoning" or "silicosis") include cognitive dysfunction, short-term memory loss, Sjogren's syndrome (dryness in the glands, such as the mouth, kidneys, eyes, and lungs), scleroderma, rheumatoid arthritis, dermatom-yositis, severe joint and muscle pain, incapacitating fatigue, swollen lymph glands, skin problems, peripheral numbness, multiple allergies, headaches, hair loss, sunlight sensitivity, central nervous system disorders (similar to multiple sclerosis), and others.

Among 176 breast implant patients examined by doctors at the Hospital for Joint Diseases, Orthopedic Institute in New York City, the most frequently reported symptoms were chronic fatigue (77%), cognitive dysfunction (65%), severe joint pain (56%), dry mouth (53%), dry eyes (50%), hair loss (40%), and difficulty in swallowing (35%).

Chemicals in Breast Implants

Below is a list of only a few of the chemicals which experts have found in explanted breast implants. People working in the plants that manufacture these chemicals limit their exposure to them. It's unbelievable that we permit this type of internal chemical exposure.

  • Methyl Ethyl Ketone
  • Flux (A metal cleaning acid)
  • Denatured Alcohol
  • Talcum Powder
  • Acetone
  • Color Pigments
  • Lacquer Thinner
  • Printing Ink
  • Antioxidant (Rubber)
  • Freon Naphtha (Rubber solvent)
  • Silicone Benzene (A known carcinogen)
  • Platinum

Methylene Chloride/Dichloromethane breaks down in the body so blood cannot carry oxygen. It metabolizes carbon monoxide poisoning and causes central nervous system depression.

Women have suffered in an attempt to enhance theor physical appearence.  The Breast Implant Helpline is here for you

Toxic Silicone Poisoning has made  The  Breast Implant   the GREATEST TRAVESTY AGAINST WOMEN in the 20th century. 


The Outrage of Silicone Continues, Breast Implants, Now Testicles

Written by lisaspitzer on . Posted in Breast Implant News

Breast implant scandal Has reached New Heights

The breast implant health scare has taken a further twist with a claim the French company at the heart of the scandal also made implants for male patients.

Two former employees of Poly Implant Prothese said the firm manufactured testicle, buttock and chest implants, mainly destined for export, Le Parisien reported on Thursday.

"Three people were specially trained to work on the machine that made silicone testicles," a former PIP worker told the newspaper.

A second said: "It was an injection machine that had clearly cost a lot of money. It was bought in with the purpose of entering into different areas of the [implant] market.

"It was used during the last few years in the company. Most of what was produced was sent abroad."

The testicle implants were destined to be used for reconstruction in patients who had lost a testicle through cancer or amputation or had been born with only one.

The newspaper said it was not clear if silicone used in the testicle implants was sub-standard. But one of the former employees said the gel used in the buttock and chest implants, aimed at male patients, was the same as the industrial quality material used in the breast implants that, it is claimed, have a high risk of rupturing.

"For aesthetic reasons some of our clients, especially those in South America, ordered them and in that case the gel used to make them was the suspect gel that did not conform [to health standards] that was already used in the breast implants. It might cause health problems in certain patients," said the ex-PIP worker. He said false pectorals were aimed at men who felt they were "not very well-built".

In a separate report, leading French cancer treatment centres including the respected Marie Curie Institute were said to have been seduced by the low price of PIP breast implants for use in reconstructive surgery after mastectomies.

Le Figaro claimed 16 of the country's 18 leading cancer institutes used the PIP implants up to 2010. A plastic surgeon told the newspaper that hospital authorities in Paris preferred to keep the number of suppliers of medical devices to a minimum.

"For many years PIP was kept on as supplier to the three public cancer treatment centres in Paris and the banlieue," he said, adding that PIP prosthetics were also used "in surgery lessons or in demonstrations at conferences".

The French health agency AFSSAPS said: "In France the company did not declare anything other than the production of breast implants. But we are only aware of what was produced on national soil."

Yves Haddad, lawyer for Jean-Claude Mas, the founder and former head of PIP, said his client would not be making any comment over the latest allegations.

Mas's son, Nicolas Lucciardi, admitted the company had acted fraudulently but said the French government should not have ordered the 30,000 women in France fitted with PIP implants to have them removed.

"Everyone is jumping on us. We admit there was a fraud when PIP didn't declare the type of gel used in the fabrication of its implants," he said, adding that the company had "ceased all activity" in the field.

He described the French government's action as aberrant. "The minister gave in to the call of the public opinion sirens," he said. "Nobody has proved they cause cancer."

An investigation has been launched in France into charges of "manslaughter and unintentional injury" against PIP, which supplied 65 countries and was once the world's third largest manufacturer of breast implants.

On Wednesday local judge Annaïck Le Goff visited the former PIP headquarters at La Seyne-sur-Mer in the Var in Provence, south-east France, and left with an armful of files.

A parallel investigation has been opened into "aggravated deception".

So far 2,400 French women given PIP implants have lodged legal complaints

In the U.S Breast Implant Helpline Is assisting women with Breast Implant claims. Lets hope the others never make it here.

New Silicone Breast Implants Approved, Breast Implant Helpline

Written by lisaspitzer on . Posted in Breast Implant News

New Silicone Gel-filled Breast Implant Approved with Conditions

Saturday, March 10, 2012 :: Staff infoZine

Long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes, still to be studied.

Breast Implant Helpline hears from women on a daily basis regarding their breast implant complications from the prior breast Implant Fiasco. Women have gotten debilitating diseases from the silicone toxicity of leaking breast implants. The results of the lawsuits and the the continued settlements are still going on as new breast implants are approved.

Washington, D.C. – infoZine – The U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.

As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery

With today’s approval, there are now three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and Sientra.

“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health.

“It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.” said Maisel.

The FDA based its Sientra approval on three years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

Breast Implant lawyers are currently helping women who have filed claims with deficiency notices and proof of disease and manufacturer. Many women were harmed by silicone breast implant toxicity from the silicone in the Implants.

In June 2011, the FDA released a report that included preliminary safety data from post-approval studies from earlier breast implant approvals. The experience collecting and analyzing data from these studies informed the design and structure of post-approval studies for Sientra breast implants.

In addition to other post-approval conditions, Sientra will:

continue to follow the 1,788 clinical trial participants in their pre-market study for an additional 7 years;

conduct a 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer; and

conduct five case-control studies that will evaluate the association between Sientra’s silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

“The design of these post-approval studies will require Sientra to collect valuable safety information with adequate enrollment and follow-up,” said Maisel. “The FDA is committed to working with breast implant manufacturers to collect useful post-market data on long-term safety and effectiveness.”

This is all well and good but, what about the thousands of women with diseases and prior breast implant claims. Many of these women are suffering with silicone toxicity related diseases from ruptured and leaking breast implants. Class action lawyers are still helping women with prior breasrt implant claims.

FDA and breast Implants a Regulatory History

Written by lisaspitzer on . Posted in Breast Implant Blog

Regulatory History of Breast Implants in the U.S.


1976 Congress passed the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.  Breast implants were placed into Class II and reviewed through the premarket notification [510(k)] process.
1988 In response to emerging safety concerns, the FDA re-classified breast implants to class III devices (requiring premarket approval). However, in accordance with the law, they continued to be reviewed through the 510(k) process until the FDA issued a rule calling for submission of premarket approval applications (PMAs).
1991 – April The FDA issued a final rule calling for submission of PMAs for silicone gel-filled breast implants.
1991 – November The FDA held an Advisory Panel meeting to discuss several PMAs for silicone gel-filled breast implants. While the panel concluded that the manufacturers had failed to provide adequate safety and effectiveness data for their implants, they unanimously recommended that the FDA permit the implants to remain on the market.
1992 – January The FDA announced a voluntary moratorium on silicone gel-filled breast implants, requesting that manufacturers stop supplying them and surgeons stop implanting them, while the FDA reviewed new safety and effectiveness information that had been submitted.
1992 – February Based on new information, the FDA held a second Panel meeting to re-evaluate the safety of silicone gel-filled breast implants.  This time the panel recommended that silicone gel-filled breast implants be removed from the market pending further evaluation of the new data.
1992 – April The FDA concluded:




  • None of the PMAs submitted for silicone gel-filled breast implants contained sufficient data to support approval.
  • Access to silicone gel-filled breast implants should continue for patients undergoing breast reconstruction or for replacement of existing silicone gel-filled breast implants (revision).  Implants used for these indications should be considered to be investigational devices, and women who received them should be followed through adjunct clinical studies.
1992 – July The FDA approved Mentor's Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 – March The FDA approved Allergan’s (formerly Inamed) Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 – June The FDA approved Allergan’s investigational device exemption (IDE) study (i.e., Core Study) for its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. This is the Core Study for submission
2000 – March The FDA held an Advisory Panel meeting to discuss three saline-filled breast implant PMAs.  The Panel recommended that the FDA approve two of the PMAs but not the third.
2000 – May The FDA approved the first PMAs for saline-filled breast implants.  for Allergan (formerly McGhan) and P990075 for Mentor.  These implants were approved for augmentation in women age 18 and older and for reconstruction in women of any age.
2000 – August The FDA approved Mentor's IDE study (i.e., Core Study) for its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. This is the Core Study for submission P030053
2002 – July The FDA held an Advisory Panel meeting to update the Panel on postmarket (after approval) information and data for the two approved saline-filled breast implant PMAs.
2002 – December Allergan submitted a PMA for its silicone gel-filled breast implants.
2003 – October The FDA held an Advisory Panel meeting to review Allergan’s PMA for its silicone gel-filled implants . In a 9 to 6 vote, the panel recommended approvable with conditions, including a minimum age requirement for augmentation.
2003 – December Mentor submitted a PMA  for its silicone gel-filled breast implants.
2005 – April The FDA held an Advisory Panel meeting to review Allergan’s updated PMA and Mentor’s PMA. In a 5 to 4 vote, the panel did not recommend approval of Allergan's PMA (due to a concern with one style in the application). In a 7 to 2 vote, the panel recommended approvable with conditions for Mentor's PMA. The panel recommended that FDA require conditions including a minimum age requirement for augmentation and Post-Approval Studies. 
2006 – November The FDA approved Allergan and Mentor’s PMAs for silicone gel-filled breast implants.  This was the first time silicone gel-filled breast implants were available for augmentation, in addition to reconstruction and revision, since the moratorium was established in 1992.  As conditions of approval, each manufacturer was required to conduct 6 post-approval studies to further characterize the safety and effectiveness of their silicone gel-filled breast implants and to answer scientific questions that the premarket clinical trials were not designed to answer.
2011 – January The FDA issued a Safety Communications on anaplastic large cell lymphoma (ALCL) in women with breast implants.  Based on a review of the scientific literature, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.
2011 – June The FDA issued an Update It included preliminary results of the post approval studies Allergan and Mentor were required to perform as conditions of their silicone gel-filled breast implant 2006 approval.


Silicone Implant Stories, Breast Implant Helpline

Written by lisaspitzer on . Posted in Dow Corning Breast Implant Stories and Sharing

Helping with Breast Implant Claims filed woth the Dow Corning Trust. You must be registered with Dow Corning.
K.MRuptured Implants Can Require Surgery
 K M has a story to share. She had silicone implants for breast augmentation in her late 20s.  But she noticed something years later.
"When I was crossing my left arm across my body — for instance, to put lotion on my right arm — I would make a little noise from my armpit, the way little boys do when they stick their hand in their armpit and pump their arm up and down," Marion says. "A little tooty noise."
An MRI showed both her implants had burst. Her doctor immediately recommended removing them, which she did. Marion hasn't suffered any apparent harm from her ruptured implants, and she even confesses to having an occasional twinge of regret that she didn't have them replaced when she had the old ones removed. But ultimately she decided she didn't want to go through more surgery.
There is a huge deficiency of long-term data on silicone Breast Implants at a time when we know that the longer these devices are in, the more problems there are:


– Sid Wolf, with the non-profit watchdog group Public Citizen
"Well, how long would these next ones last? I would be in my 60s when I had to do this again, and who wants to have surgery unnecessarily when you are 60 something?" says Marion.
Although the long-term effects of silicone in the body are still uncertain, many plastic surgeons don't see the leaking of modern implants as a health concern.
"The actual silicone that's within the implants is inert. So if the silicone gel leaks, it doesn't travel through the body, it doesn't cause systemic problems. So the MRI is really detecting a cosmetic concern," says New York City plastic surgeon Matthew Schulman.
But there have been more serious outcomes. A K got silicone implants in 1991 following a double mastectomy. For years afterward she felt ill, suffered multiple bouts of pneumonia, had trouble breathing and pain in her chest. Doctors reassured her it wasn't her implants.
"We had a CT scan done, and it showed OK — everything looked fine, so we didn't worry about it," says Knecht.
But no one ever told her to get an MRI — something the FDA now recommends that women with silicone implants get every few years. As it turned out, Knecht's implants had leaked; a biopsy found silicone in her lymph nodes and in her lungs. She is currently disabled and awaiting a lung transplant — all, she says, for vanity.
"We're about four generations removed from those implants," says Schulman, the plastic surgeon. He explains that implants have undergone big changes since the early 1990s, when Knecht received hers. Back then they contained a runny liquid silicone.
"The silicone implants of today are what we call a cohesive gel — it's essentially like a jelly. So the jelly may ooze a little bit, but it will not run out like an oil," says Schulman.
Public Citizen says
Sid Wolf of the nonprofit watchdog group Public Citizen is among critics who point out that the data in the FDA report sample just a fraction of the nearly 400,000 women who receive breast implants each year. Moreover, that data are limited to just the last two or three years — not enough, Wolf says, to make any real claims about the long-term safety of the implants.
"There is a huge deficiency of long-term data at a time when we know that the longer these devices are in, the more problems … occur," says Wolf.
by Mary McDonough
Since I went public with my breast implant problems six years ago, hundreds of women have contacted me desperate for trustworthy information about breast implants. Like me, they underwent various operations they were told were perfectly safe then had terrible problems. To add insult to injury, they couldn't find out how to get better.


I founded In the Know as a support group for women in the entertainment industry who are struggling with these issues. It is essential that we all get "in the know."


My implants ruptured and have been removed. However, I still have platinum and silicone that has crystallized in my saliva, my mucous, urine, and blood. My eyes, ears and nose also ooze crystallized platinum and silicone. As a direct result from the chemicals and heavy metals used to manufacture silicone gel breast implants, I suffer daily with the symptoms of M.S, lupus, visual problems, fibromyalgia….

Sandhya Pruthi, M.D.

The major problem associated with ruptured silicone breast implants is the formation of scar tissue in the breast. If the rupture isn't addressed, the scar tissue can lead to pain and changes in the contour or shape of the breast. However, there's no scientific evidence that ruptured silicone breast implants cause serious, long-term health problems — such as breast cancer or connective tissue diseases

A Personal Story

Well, as I type this – 3 surgeries and months later, I am finally showing signs of improvement.  Many woman do get better, some take up to 2 years, and many women never fully recover. My medical file is about 5 inches thick, I am on a lot of medication and I have a team of about 6 doctors I see at USC now.  They are all fascinated and with this happening to so many women and it is so hard for me to believe how bad the medical community is kept in the dark.  They love learning new things and are excited to help and often get discouraged that they can't – but I don't like being a lab rat or a medical discovery center. This is not what I thought I was signing up for.

I still don't know if I will ever be 100% again. I have been diagnosed with Mixed Connective Tissue Disease (MCTD), Chronic Fatigue Syndrome (CFS), Fibromyalgia (FM), Epstein-Barr Diease and like I said.. I have had many Lupus and MS symptoms, but I don't test positive for the diseases.  I have also had new thyroid and adrenal fatigue problems and I even have unexplainable blocked blood flow in my brain and lesions or marks on my brain that can't be pinpointed. With all of this, as you can imagine, it is very frustrating for my family and I and we have lost tens of thousands of dollars along with precious time that we'll never get back.

another source on Breast Implants

Self-reported conditions

Three hundred fifty-one (4.8 percent) of the implant patients and 62 (2.9 percent) of the comparison patients reported a diagnosis of one of four major CTDs (rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or Sjögren’s syndrome), generating a relative risk of 2.0 (95 percent confidence interval (CI): 1.5, 2.8)  Significant risk elevations were noted for rheumatoid arthritis (relative risk (RR) = 1.9, 95 percent CI: 1.4, 2.7), systemic lupus erythematosus (RR = 2.1, 95 percent CI: 1.1, 4.2), and Sjögren’s syndrome (RR = 11.7, 95 percent CI: 2.5, 54.9). Scleroderma was associated with a threefold risk on the basis of 23 implant patients and three comparison subjects. Significant risks were also observed for Raynaud’s phenomenon (RR = 2.6, 95 percent CI: 1.3, 5.1) and chronic fatigue syndrome (RR = 2.4, 95 percent CI: 1.6, 3.6).

P & S a breast Implant Husbands Story

S and I have been together since 1999 and, until she became a participant in the silicone breast implant study, she was extremely healthy, physically active, very confident and a lot of fun to be around. In 2005, almost immediately after she had her existing saline breast implants replaced with silicone implants, her health, her life and my life began to change. Not only would S described to me the unusual things that she was feeling, but I could definitely notice some of the changes taking place in her. She started complaining of things like dizziness, various joint pains, physical and mental anxieties, blurred vision and a host of other symptoms that were all new and that we did not understand the origin of at the time…

and Last  A Snake dies of Silicone poisoning from Biting a Models Breast

Model Orit Fox has unwittingly killed a snake after it bit her surgically-enhanced breasts and died of silicone poisoning. Fox – Israel's answer to Katie Price – was handling the normally tame snake on Spanish TV when she attempted to lick its face. Evidently finding this rather provocative, the snake reacted badly, clamping down on Fox's ample chest. Fox was rushed to hospital where she received a tetanus jab, but she suffered no long-term damage. Unfortunately the snake did not survive.