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  • Dow Corning Breast Implant Litigation Lawyers: Breast Implant Lawyers Accepting Dow Corning Breast Implant ClaimsOur Breat Implant lawyers are reviewing Dow Corning Breast Implant Claims for women implanted with Dow Corning implants prior to June ...

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  • Dow Corning Breast Implant Litigation Resources: The Claimants’ Advisory Committee (CAC) is the official committee appointed by the U.S. District Court in the Eastern District of Michigian to represent the interests of women in the Dow Corning Bankr...

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  • Dow Corning Breast Implant Litigation Resources: The Claimants’ Advisory Committee (CAC) is the official committee appointed by the U.S. District Court in the Eastern District of Michigian to represent the interests of women in the Dow Corning Bankr...

Posts Tagged ‘Houston’

Dow Corning Breast Implant Litigation Resources

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

The Claimants’ Advisory Committee (CAC) is the official committee appointed by the U.S. District Court in the Eastern District of Michigian to represent the interests of women in the Dow Corning Bankruptcy Settlement Plan. They have a website with information concerning the Settlement Facility for the Dow Corning Trust (SF-DCT).

CONTACT INFORMATION

Phone Number: 419-394-0717

Fax: 419-394-1748

Email address: info@tortcomm.org,

Mailing address: Claimants’ Advisory Committee, P.O. Box 665, St. Marys, OH 45885.

You can also sign up on the website to receive a free copy of their monthly electronic newsletter by e-mail.

LATEST COURT ORDERS ON THE WEBSITE

July 31, 2014 – 6th Circuit Court of Appeals affirmed that tissue expanders are included in the definition of “Breast Implants” June 20, 2014 – Stipulation and Order Recommending the Appointment of the Honorable Pamela R. Harwood as Lien Judge March 31, 2014 – 6th Circuit Court of Appeals ruled Denying Dow Corning’s Motion to Stay Partial Premium Payments February 25, 2014 – Order Denying Motion to Stay Pending Appeal.

LINKS TO RELATED WEBSITES

Settlement Facility website: www.dcsettlement.com
Email address: info@sfdct.com
Mailing address: Settlement Facility – DC Trust P.O. Box 52429 Houston, TX 77052-2429
Phone Number: (713) 874-6099
Toll free Phone Number: (866) 874-6099 (within the U.S.)
International Toll Free Number AT&T Direct Access Number: + 866 + 874 6099 (outside the U.S.)
MDL 926 Claims Office for the Revised Settlement Program:
Website: www.fjc.gov (MDL 926 Court)
Website: www.claimsoffice-926.com (MDL 926 Claims Office) The MDL 926 Claims Office website is still under development, so some “headings” do not have any information listed. Additional information will be posted as it becomes available.
Email address: claimsoffice926@aol.com
Mailing address: MDL 926 Claims Office P.O. Box 56666 Houston, TX 77256
Phone Number: 1-800-600-0311
United States District Court for the Eastern District of Michigan
Website address: www.mied.uscourts.gov

For a Dow Corning Breast Implant Lawyer contact the Dow Corning Breast Implant Helpline

Our lawyers are private practice lawyers. They are not employed by or affiliated with the Dow Corning Claims Settlement Office. If you hire one they are your advocates for you.

Dow Corning Breast Implant Litigation Lawyers

Written by lisaspitzer on . Posted in Breast Implant Blog, Breast Implant News, Dow Corning Breast Implant Stories and Sharing, Silicone Poisoning and Silicone Breast Implants

Breast Implant Lawyers Accepting Dow Corning Breast Implant ClaimsOur Breat Implant lawyers are reviewing Dow Corning Breast Implant Claims for women implanted with Dow Corning implants prior to June 1, 1993 and who are registered with the SF-DCT.

We are here to help with your Dow Corning silicone breast implant claims and will connect you with  a female silicone breast Implant lawyer who has been  helping women for 2 decades.  Our lawyers have  helped women obtain settlements for breast implant diseases such as Lupus, Scleroderma and General Connective Tissue Diseases.

DECEMBER 3, 2015

The District Court issued an Order approving the Consent Order To Establish Guidelines for Distributions From The Class 7 Silicone Material Claimants’ Fund. This means that the Court has authorized approved disease claims in Class 7 to be paid and has approved the parties’ agreed interpretation of “marshaling.” The order will become final once the 30-day time period for appeals has expired and no appeals have been filed. Payments can begin once the Order is final. This means that payments will not begin until sometime in January 2016 or thereafter.

 

DECEMBER 1, 2015

Copy of the SFDCT letter sent to claimaints with an approved Disease Option 2 claim regarding Increased Severity – Please note the deadline date of June 2, 2019 is incorrect. The correct deadline date is June 3, 2019. To read the response, click here.

SEPTEMBER 15, 2015

Omnibus Response to Objections & Submissions Responding to Consent Order to Establish Guidelines for Distribution From Class 7 Silicone Materials Claimants Fund. To read the response, click here.

JULY 29, 2015

Scheduling Order Regarding Consent Order to Establish Guidelines for Distributions from Class 7 Silicone Material Claimants’ Fund. To read the order, click here.

JULY 17, 2015ATTORNEYS:

Wells Fargo, the paying agent for the SF-DCT, requires law firms to provide an updated w-9 before payment can be issued. You can download a copy of the updated w-9 form here. Please complete and return the w-9 to the SF-DCT.

JUNE 12, 2015

Copy of the Notice to Class 7 Claimants Establishing Guidelines mailed by the SFDCT. To read the notice, click here.

JUNE 2, 2015

Judge Hood as issued an Order Authorizing Distribution of the Notice in reference to the Class 7 Consent Order. To read the order, click here.

MAY 26, 2015

CAC FILES MOTION ASKING FOR APPROVAL TO PAY CLASS 7 CLAIMS AND TO RESOLVE THE DISPUTE CONCERNING PREVIOUSLY DENIED “MARSHALING” CLAIMS

On Friday, May 22, 2015, the CAC filed a proposed Consent Order asking the Court to authorize payment of disease claims for Class 7 claimants. Most claimants in Class 7 have been previously paid a $600 Expedited Release Payment, a Foreign Gel Claimant Payment, or a $3,000 Cash-Out Offer. Claimants that rejected the Cash-Out Offer and elected for a full disease review have been waiting for payment on their approved disease claim. With the filing of the motion, the CAC hopes that these claimants can now be paid once the Consent Order is entered by the Court.

In addition, the CAC has reached an agreement with Dow Corning regarding thousands of Class 7 claims that were previously denied by the SF-DCT on the grounds that the claimant allegedly had not “marshaled” their recoveries from their primary manufacturer (Bristol, Baxter). Under this agreement, claims will be reviewed to determine if the claimant was eligible to apply for disease compensation from the Revised Settlement Program. If so, then that claimant cannot apply for the same disease in Class 7. However, if a claimant was not eligible to receive benefits for a particular disease in the RSP, then that claimant may seek compensation from Class 7.

For example, if a claimant was an Other Registrant in the RSP, the only disease option she was eligible for was Disease Option 2 (called Long Term Benefits). Other Registrants were not eligible for Disease Option 1 (Fixed Benefits) and diseases like ACTD. These claimants may now seek compensation for Disease Option 1 from Class 7.

The SF-DCT will re-review the claims that were previously denied and will send eligible claimants either a $600 Expedited Release Payment or $3,000 Cash-Out Payment. The Cash-Out Payment is available only to those claimants who submitted a disease claim in 2006. Claimants may reject the Cash-Out Payment and instead elect for a full disease review; however, if the claim is not approved, they will not be eligible for the Cash-Out Offer again.

 

MAY 4, 2015

The MDL Common Benefit Trust fund has announced that it will offer women who were not compensated for Explantation in either the MDL or Dow Corning Settlement a chance to apply for $5,000 explant payment. For more information about this program, please click here. Please note that this program is not affiliated with either the RSP or Dow Corning Settlement Plan.

If you are having difficulty getting your medical insurance to cover the cost of the explant surgery, there is a new resource for women. The Insurance Coverage Assistance Program will be available to provide advice and assistance on how to assess this Medicare, Medicaid, and health care coverage for issues related to breast implants. This program is to be operated by the National Center for Health Research, a consumer-oriented non-profit group in Washington, D.C., that has helped women seek insurance coverage for breast implant removal. The National Center currently operates the breastimplantinfo.org website. You may email them at info@breastimplantinfo.org with your name and email address for more information, including their toll-free number. If you do not have access to email, you can call them at 202-223-4000.

FEBRUARY 10, 2015

On January 27, 2015, the Court of Appeals reversed the District Court’s authorization to make 50% partial Premium Payments. Fortunately, the SF-DCT has already made 98% of the partial Premium Payments to eligible, approved claimants. This money does not need to be repaid. Claimants can keep the partial Premium Payment checks that were issued to them. Unfortunately, the remaining 2% of claimants who did not receive their partial Premium Payment check (or returned it for reissuance, or who had lost checks) are on hold pending either a consensual resolution to pay their claims or a court order. A copy of the ruling is under the tab “Court Orders.”

February 10, 2015,

CAC filed a petition for rehearing on this ruling, asking the Court of Appeals to reconsider or rehear the issue based on what the CAC believes are two serious legal errors. A copy of the petition is under the tab “Appeals to the 6th Circuit” and then under the sub-tab “Premium Payments.”

IF YOU NEED HELP WITH YOUR DOW CORNING BREAST IMPLANT CLAIM CONTACT US TODAY

 

Dow Corning Breast Implant Lawyers Important News And Update

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

News Regarding the Dow Corning Expedited Release Checks

 

The Settlement Facility Dow Corning Trust has recently decided to send Expedited Release Payments in the amount of  $2,000 to all Dow claimants whose cases are idle.

Important Information Regarding Accepting This Offer

Be aware that if you accept this payment you can NEVER apply for a disease claim in the future, even if you become sick.

 What Should I Do Id I Receive An Expedited Release Check?

If you receive an expedited release check in the mail,  you should not cash it. Call us to speaker to a Dow Corningg Breast Implant lawyer to make sure you are doing the right thing.

Dow Corning Settlement Alert

If you cash the expedited release check   you will be agreeing to  settle your claim and can never get any additional funds.

New Silicone Breast Implant Approved

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

Breast Implant Helpline keeps you updated on all breast implant news. Years after the Dow Corning Silicone Breast Implant disaster a new silicone breast implant hits the market. The FDA has  approved a  new silicone gel breast implant from Johnson & Johnson.

 Next Generation breast Implant?

The Food and Drug Administration said it has  approved a next-generation silicone breast implant from Mentor, a unit of New Brunswick-based Johnson & Johnson. Ladies let’s remember who this is. The same folks that bring you the vaginal mesh implant that is ruing lives nationwide. We watch with skepticism. The company’s MemoryShape breast implant uses a cross-linking gel design that the FDA says is firmer than previous implants. FDA regulators approved the new implant for breast enhancement and reconstruction in women at least 22 years old.

Can Silicone Breast Implants Make A Comeback?

Silicone gel implants have made a comeback recently after safety concerns kept them off the market for nearly 25 years.

The FDA banned sales of silicone breast implants in 1992, saying manufacturers had not provided enough medical data showing their safety and effectiveness. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern. Women are still waiting on settlements from the Dow Corning Class Actions and a new breast implant explant program has been announced.

An Overview

The FDA said Friday it approved Mentor’s new implant based on studies tracking six years of data in 955 women. The agency said complications with Mentor’s MemoryShape implants were similar to those from previously approved silicone gel implants.

 New Requirements

FDA is requiring Mentor to meet a number of requirements in connection with the new approval, including:

• Tracking the 955 women with the new implant

• Conducting a new study of 2,500 women who receive the new implant

• Evaluating women’s comprehension and perception of the implant’s labeling

• Analyzing any implants that are removed from women and returned to the manufacturer

More than one in five women who get implants for breast enhancement will need to have them replaced within five years, accord to an FDA analysis of company data released in 2011. Despite that relatively high failure rate, FDA regulators concluded that the silicone-gel implants are basically safe, as long as women understand they come with complications. Some critics of the implants say the failure rate may be even higher, since many women have dropped out of the company studies.

We will be watching.

Dow Corning Breast Implant Explant Program, Breast Implant Lawyers

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

You may have received a letter from the Dow Corning Trust explaining a Breast Implant explant program. For help in understanding your rights and to speak to a breast implant explant lawyer contact the Breast Implant Helpline today

There is a Breast Implant Explant Program Deadline

The final deadline to submit an Explant Claim to the SF-DCT is June 2, 2014. You must have acceptable Proof of Manufacturer before you can be considered for the Explant benefit. The Explant benefit is $5,000.00. To qualify for this benefit, you must have your Dow Corning implants removed and not replaced with silicone.

It can take six months or longer to schedule an explant surgery and to obtain the necessary medical records from your surgeon or hospital.  If you are eligible  to apply for this benefit, you should keep this deadline date in mind. Do not  wait  to discuss your  explant surgery with your doctor. This should be done as soon as possible.

What Is Breast Implant  Explant Surgery?

Breast explant surgery  is mplant removal. Explant surgery is the process by which your breast implants are removed from the breasts. Depending upon the reason for the surgery, additional material may be removed.

Dow Corning Explant Benefits Notice

EXPLANT DEADLINE IS JUNE 2, 2014

The Settlement Facility will mail letters to Class 5 and 6 claimants on April 26, 2013 reminding them of the Explant Deadline of June 2, 2014.

What is the Explant Deadline? To be eligible for the $5,000 Explant benefit (Class 5 only), you must have your Dow Corning breast implant removed by June 2, 2014 and you cannot receive another silicone gel breast implant after that. To file a claim, you must submit the Explant Form and the operative statement from the Explant surgery. Only claimants in Class 5 and 6.1 (non-U.S. Dow Corning breast implant claimants) are eligible for the Explant Payment.

June 2, 2014 may seem like a long time away, but our experience has been that it often takes up to 6 months or more to schedule an appointment with your surgeon, schedule the surgery, and obtain the necessary medical reports (such as the Operative Report) to submit a claim by the deadline.

If your Dow Corning breast implant is not removed by June 2, 2014, then you cannot apply for the Explant benefit.There is still money available to help you remove your defective Dow implants. There is money available to help you remove your defective breast implants

 

Drugs and Devices Harming Women, VaginaL Mesh, Mirena IUD, And Others

Written by lisaspitzer on . Posted in Dow Corning Breast Implant Stories and Sharing, Drugs and Devices Harming Women

There have been so many drugs and devices targeting women over the years with so many ending up in FDA warnings, recalls and resulting in lawyers in the courtroom arguing for justice for 1000's of injured women. To name a few; equal and maybe far surpassing the Dow Corning Breast implant Class Action is the Prolene vaginal mesh. This device, used by OB GYN's for urinary incotinence and  uterine, bladder and bowel prolapse, has been falling apart in women. The result has been pain suffering and  the destruction of lives and marriages.

The failing mesh can erode thru the vaginal wall or even into the bladder or bowel, The pain is relentless and infections are ongoing. Many women are having a difficult time finding sympathetic doctors to remove the mesh as urinary incotinence returns and re prolapse occurr.

Two others are both manufactured by Bayer Pharmaceuticals. Yaz birth control pills has warnings for blood clots in young women, strokes, pulmonary embolisms and deep vein thrombosis. The latest is the popular Mirena IUD.  The Mirena can stay inplanted for up to five years but  can gravitate or migrate and cause uterine and abdomen perforations. The stories of lives ruined goes on and on. Even the metat on metal hip replacements like the recalled DePuy and Stryker are more detrimental to women sdue to the smaller frames.

Every day we hear about more  dangerous drugs and medical devices. Our T.V's are filled with lawyer ads seeking injured women. These products like Fosamax, birth control medications and uterine devices; the transvaginal mesh and metal-on-metal hip implants all focus on women as their market. Eventually these products  end up with warnings, are recalled and are consolidated in a multi-district litigation to defend 1000's of harmed women. In some cases they are fatal.

These products we see lawyer ds for include: Yaz, Transvaginal Mesh, Mirena IUD, Fosamax, DePuy Hip Replacement  and others  are flashing cross our T.V screens " have you been injured by" "Call th law firm of….." We encourage women to file their lawsuits, not necessarily with the lawyer they see on T.V but with a qualified experienced class action lawsuit lawyer who understands the MDL process and has experience in these matters. Be sure the lawyer you choose is not just taking your case to get his piece off the top and sending it to a"buddy".

The Breast Implant Helpline's new mission is to help all women find justice against manufacturer who choose profits over  accurate warnings, and direct you to a dangerous drugs and devices lawyer for women.

 

 

How Much Can a Dow Corning Breast Implant Lawyer Charge

Written by lisaspitzer on . Posted in Breast Implant Blog

Breast Implant Helpline is helping women with their SFDCT claims. Do you need a Dow Corning SFDCT lawyer? Call us now.

How much can my attorney charge?

Pursuant to Section 5.10 of the Amended Joint Plan of Reorganization, the fees and expenses of an attorney representing any claimant who receives payment from the Settlement Facility are limited to the following:

The fees shall not exceed the sum of:
    (a) 10% of the first $10,000 paid to the claimant
    (b) 22.5% of the next $40,000 paid to the claimant
    (c) 30% of the amount in excess of $50,000 paid to the claimant

Your attorney is allowed to charge actual expenses incurred in representing you. For more information on allowed attorney fees and expenses, refer to the Amended Joint Plan of Reorganization, The Claimant Information Guide, section 9.01 of Annex A To Settlement Facility and Fund Distribution Agreement and the Agreed Order Adopting Q&As Regarding Article IX of Annex A, The Claims Resolution Procedures.

50 Years of Breast Implants, Silicone Breast Implant Class Action

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

50 years of fake breasts. This year marks the 50th anniversary of silicone breast implants. Breast Implant lawyers are still helplng women get compensation for the silicone breast implant class action.

By MARILYN KALFUS / THE ORANGE COUNTY REGISTER

This year marks the 50th anniversary of silicone breast implants.

But breast augmentation began long before the spring of 1962.
Article Tab: implant-breast-worker-pla
This Spring marks a plastic surgery milestone. It's the 50th anniversary of silicone breast implants.

Substances were injected into women's chests, researchers say, since at least the late 1800s. They included paraffin, animal fat and industrial silicone.

The 1950s saw all sorts of materials transplanted, even glass balls and sponge implants. The latter shrank, becoming hard as baseballs.

Then, one day in the mid-20th century, after the advent of Playboy, the Barbie doll and high-profile celebrities like Marilyn Monroe (thought to have worn "falsies") and Jayne Mansfield (considered natural), a plastic surgeon had an "aha" moment.

Dr. Frank Gerow of Houston squeezed a plastic transfusion bag filled with blood and realized if felt a lot like a woman's breast. In 1961, he and Dr. Thomas Cronin developed the first silicone breast implant in collaboration with the Dow Corning Corp.

1962: Texas factory worker Timmie Jean Lindsey gets the first set of silicone breast implants after doctors propose that she be their first human subject. "I told them I'd rather have my ears fixed than to have new breasts," the mother of six was quoted as saying. "And they said, well, they'd fix that too. So I said, OK." Lindsey, now 80, went from a B to a C cup and made history.

1970s: New silicone implants are produced that are more "lifelike," but they break more easily. Total removal is difficult or impossible. Also in this decade, a polyurethane foam covering for implants becomes popular to prevent capsular contracture – capsules of tightly woven collagen fibers created by the immune response to the presence of foreign objects – but the foam begins to disintegrate in the body almost immediately, making it difficult to remove.

1976: The Food and Drug Administration enacts the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act. The FDA now can approve the safety and effectiveness data of new medical devices. Silicone breast implants, on the market for almost 15 years by then, are "grandfathered" in.

1977: A Houston attorney wins the first lawsuit for a Cleveland woman who claims that her ruptured implants and subsequent operations caused pain and suffering. She gets a $170,000 settlement from Dow Corning.

1980s: Ralph Nader's Public Citizen Health Research Group warns that silicone breast implants may cause cancer.

1982: The FDA proposes to classify silicone breast implants into a Class III category, requiring manufacturers to prove their safety.

1984: The systemic autoimmune disease of a woman in the San Francisco area is found by a jury to be caused by her silicone breast implants. She is awarded $211,000 in compensatory damages and $1.5 million in punitive damages. The evidence is sealed by a court order.

In the years that follow, there is litigation all over the country alleging that breast implants caused various serious diseases and ailments.

In the end, and despite millions of dollars in payments to plaintiffs in class-action lawsuits and jury trials, scientists say they can find no cause-and-effect relationship.

June 1988: Six years after the 1982 proposal, the FDA classifies breast implants as Class III.

December 1990: A program warning of silicone breast implant dangers runs on "Face to Face With Connie Chung." Also, a congressional hearing is held on the safety of silicone breast implants.

January 1992: The FDA's commissioner, Dr. David Kessler, calls for a voluntary moratorium on the distribution or implantation of silicone breast implants until the FDA and the advisory panel have an opportunity to consider newly available information.

March 1992: Dow Corning, Bristol-Myers Squibb and Bioplasty exit the silicone breast implant business. McGhan and Mentor still manufacture breast implants. Dow sets up a fund for further research into breast implant safety.

April 1992: Kessler lifts the moratorium on silicone breast implants, but the only women allowed to receive implant surgery are those undergoing breast reconstruction. The recipients must be part of a scientific protocol.

March 1994: A class action suit is finalized by manufacturers; Dow Corning is the largest contributor. The other contributors include Baxter, Bristol-Myers Squibb/MEC, and 3M. It's the largest class action settlement in history. But the manufacturers claim there is no scientific evidence linking silicone breast implants with autoimmune diseases.

June 1994: A Mayo Clinic epidemiologic study, published in the New England Journal of Medicine, finds no increased risk of connective-tissue disease and other disorders studied in women who had silicone implants.

1995: The American College of Rheumatology says there is "compelling" evidence that implants did not cause systemic disease.

May 1995: Dow Corning files for Chapter 11 bankruptcy. Dow is looking at 20,000 lawsuits, some with more than one plaintiff, and about 410,000 potential claims that have been filed in the settlement. The bankruptcy halts all litigation.

June 1995: The Harvard Nurses Epidemiologic Study is published in the New England Journal of Medicine. It finds no increased risk of connective-tissue disease in women with silicone implants.

December 1995: More than 20 studies and abstracts have come out in the U.S. and internationally, all failing to support a causal relationship between silicone implants and various autoimmune related illnesses.

August 1997: The New York Times says implant manufacturers have won 80 percent of cases against them. But a jury in the first class-action suit rules that Dow Chemical (which owns half of Dow Corning) deceived women by hiding safety information about the silicone in the implants.

September 1997: The Journal of the National Cancer Institute publishes a review of many medical studies that concludes breast implants do not cause breast cancer. The researchers describe evidence for linking implants to other diseases as "borderline."

November 1998: Dow Corning files for bankruptcy reorganization, which includes a $3.2 billion, previously agreed-to settlement. People who filed claims are offered options: Those who want to cash out immediately and not file a disease claim will be paid $2,000. That can be combined with $5,000 for implant removal and $20,000 for a ruptured implant. Those who have already filed a disease claim will receive between $10,000 and $250,000.

June 1999: The Institute of Medicine, part of the National Academy of Sciences, releases a 400-page report by an independent committee of 13 scientists. They conclude that although silicone breast implants may be responsible for problems including hardening or scarring of breast tissue, the implants do not cause any major diseases such as lupus or rheumatoid arthritis.

2002: Dolly Parton admits to the news media that she has breast implants. Through the years, many celebrities confirm getting them, too, including onetime Playboy Playmates and actresses Pamela Anderson and Jenny McCarthy; singer Victoria Beckham; TV personalities Denise Richards and Heidi Montag; and later, members of various casts of "The Real Housewives," including Alexis.Bellino, Vicki.Gunvalson and Tamra.Barney of Orange County (Barney recently had them removed) and Kim Zolciak of Atlanta.

2003: Mariel Hemingway talks about her experience with breast implants, saying the silicone leaked. "I think implants are bad news. I enjoyed them for about a year, then from ages 20 to 32, I was asking, 'Why do I have these? I hate these.'"

October 2005: TV personality Sharon Osbourne admits to having had breast implants inserted earlier in the year. "I am a 34DD now and Ozzy loves them," she said of her husband. She later swapped them out for more modest ones, and in 2011 said she had a complication in which one changed shape and leaked.

November 2006: The FDA allows silicone gel-filled breast implants back on the market but requires manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices. The FDA also states on its website: "Breast implants are not lifetime devices. The longer a woman has them, the more likely she is to have complications and need to have the implants removed or replaced. Women with breast implants will need to monitor their breasts for the rest of their lives."

The site also says: "Studies to date do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, no study has been large enough or long enough to completely rule out these and other rare complications.

"FDA is working with the two manufacturers who make silicone gel-filled breast implants, Allergan and Mentor, to address the challenges in collecting follow-up data on the women who have received these implants."

2010: Implants made with industrial-type silicone by French company PIP are banned. The implants were widely used across Europe and South America, and governments begin urging women to have them removed. (They are not sold in the U.S.)

March 2011: The FDA approves a new silicone-gel breast implant, making Sientra of Santa Barbara the third U.S. company to market the products, after Irvine-based Allergan and Johnson & Johnson's Mentor unit.

May 2011: Casting in Miami for a new '50s-era TV show, "Magic City," is described as difficult because local women without breast implants are apparently in short supply.

Sources: The New York Times, The Associated Press, Food and Drug Administration, Bloomberg Business News, BBC News Magazine, The Guardian, "Inventing Beauty'' by Teresa Riordan, "Frontline," American Academy of Neurology, Medscape.com, Twoop.com

Dow Corning Breast Implant Controversy, Dow Corning Breast Implant Lawyer

Written by lisaspitzer on . Posted in Breast Implant Blog

Dow Corning and the Silicone Breast Implant Controversy
posted by Handsome Devil on Wed, 01/04/2012 – 20:32

University of Wisconsin-Whitewater
 

1. What are some of the major factors that led to the Breast Implant Controversy?

Throughout the 1980s and 1990s, class-action lawsuits claimed that Dow Corning's silicone breast implants caused systemic health problems. The claims first centered around breast cancer, and then migrated to a range of autoimmune diseases including lupus, rheumatoid arthritis and various neurological problems. Ok
Even though Dow Corning has spotted the signs such as stakeholder complaints and various test reports in advance, they have not handled the problems ethically and have tried to manipulate information detrimental to themselves.
Here are a few issues we found in the article:

Ethically the company should have listened to the scores of questions from customers and their doctors about serious medical problems resulting from the use of its product; however, the company has not stopped producing the product or not done anything to improve the current situation for the stakeholder’s benefits – consumer health. Yes
Secondly, the company ignored the internal reports over lack of safety testing, as reported. The mammary task force raised a question that the product could cause “a bleed through” into surrounding tissue and the test result was still “inconclusive”, even in the new product tests the engineers didn’t make sure of the product safety. In spite of these facts, the company kept selling the product to the market.
Thirdly, the company has disregarded its social responsibility to lead its community. It seemed to limit its responsibility only within its legal responsibility in a case that its product breaks the rules. To make business ethics perfect in its community, it should take care about its full responsibility on its legal aspect and its moral ethics. The unbalanced ethics approach finally not only risked the stakeholder’s health but also increased social costs in its communities. Ok
Lastly, the top managers violated its fiduciary duty to its stakeholder even in facing the allegations that the company had hidden negative test results and lied to the public about the safety of its products. The board of the directors continued to manufacture and sell the product as well as to proceeded to fight customers who brought suit alleging injury. Ok
There are other key factors such as the competition etc that need to be discussed
 

2. What are the ethical issues and principals involved in this case? Who has acted the most and the least responsibility? Explain.

The main ethical issue of the article was whether or not breast implants, although potentially harmful to the body, should be on the market.
Since the 1960’s when Dow Corning used silicone to develop the first prototype of a breast implant, there have been ethical concerns that have not been resolved.
In the early 90’s, breast augmentation was the second most common cosmetic procedure performed by plastic surgeons, and the top money maker. Not only were breast implants important for reconstructive surgery, such as after an accident or cancer treatment, but the demand for the implants was growing more rapidly as an elective procedure. There is even a growing medical opinion that micromastia, known as flat-chestedness, is a disease which can result in a patient having a total lack of body image and low self esteem. Thus, the enlargement is necessary to insure an improved quality of life for the patient. Ok
However, as the number of breast implant patients increased, so did the number of complaints. There were allegations of the implants causing pain, scarring, and even debilitating autoimmune diseases in the patients. But how was a product that was clearing injuring patients allowed to be on the market? How ethical was it to allow these products to be so available, and yet, so potentially dangerous? Yes
First of all, breast implants were not governmentally regulated when first developed in the 1960’s. FDA could not require approval for safety and effectiveness before products were on the market.
Second, in accordance with “good manufacturing” practices, Dow Corning did attempt to determine safety of medical products before releasing them to the public. However, the determination of “safety” was vague and based on the company’s opinion. When tested on animals, silicone was injected into the body. There was clear evidence of chronic inflammation; however, because the silicone would not be injected into humans, the finding was ignored.
Third, the new and improved implants were brought into the market quickly without extensive medical testing. The reasoning for this was because similar substances had already been tested in other facilities. It was; however, brought to the attention of Dow Corning that “bleed throughs” were occurring. The company assigned a few employees to investigate (meanwhile still providing breast implant procedures). They found that the bleeding was “no greater than what we measure from old control gels”. However, it was stated that these tests were “inconclusive”, and were never researched again. Ok
Finally, in 1975, it was found that the reject rate at inspection was as high as 50% on some production lots. And yet, the implants were still available on the market.
Need to also integrate some theoretical perspective to assess Dow’s egoism + utilitarian principles
The responsibility for these ethical issues is a combination of both the Dow Corning company and the government. The Dow Corning company, although not held to any level of standards, was providing a potentially harmful product to the public. Yes Testing was done, but was not conclusive. The government (FDA) allowed companies, like Dow, to supply harmful products because they did not require extensive testing. It was not until 1989 when the FDA finally identified silicone implants as Class III devices, meaning riskiest. But still, after many hearings, breast implants were cited as a “public health need” and were left on the market.
Plastic surgeons and the public also hold some responsibility. Surgeons, although knowledgeable about the possible effects, still recommended and used the products on their patients. Many breast cancer advocacy organizations and satisfied recipients also supported Dow Corning and the use of breast implants. Ok
I

3. What was the role of the US Food and Drug Administration? Should they take some blame for the scandal? Should they have taken a more active role early in the controversy? Is the role government agencies can play in this respect limited?

In the early years of the product, the Food and Drug Administration (FDA) had very little oversight of silicone breast implants. The FDA did regulate products meant for ingestion (pharmaceutical drugs) since 1906 (Pure Food and Drug Act) but implants were considered medical devices and outside the FDA’s regulatory scope. The products could be removed from the market only if the manufacturer was proven to break the law. Despite the Medical Amendments Act to the Food and Drug Act (1976) the FDA didn’t label breast implants as dangerous until 1989 (after numerous lawsuits). Ok
The FDA should have taken an active role to regulate these products and can be considered somewhat responsible. Dow Corning was able to put a new product designed for internal human use into the market with little testing and no oversight. Their testing revealed health dangers that they ignored and kept from the public. If the product was regulated, the FDA would have seen the effects on laboratory animals – the Silicon causing inflammation as it sticks to various organs and lymph nodes. Despite intent to keep the silicon out of the body, ruptures or leaks would cause damage and users at least need to be aware of the risk before putting the product inside their bodies. Regulation would have revealed the numerous red flags (animal testing, plastic surgeons’ trade show) associated with Dow Corning’s implants and their FDA approval would have been delayed until the problems were solved. Yes
Dow Corning and other corporations have the goal of making profits and increasing their shareholders’ wealth. The FDA and other government agencies should realize this and put checks in place to ensure these companies offer safe products and services. Breast implants may not be a food or a drug but they are meant for internal use in the human body and they should have been added to the regulatory scope of the agency much earlier than they were. One of the roles of government is to protect its citizens (national defense, criminal justice, health care) and while it is often hesitant to regulate business (especially when that business makes significant contributions to political campaigns) when blatantly dangerous products are made available to consumers, the government does have and should use its authority to regulate and prohibit sales of these devices.
 

4. Why did Dow’s exemplary formal code of conduct fail in preventing the controversy? What can be done to make a Code of Ethics more effective?

Dow’s exemplary formal code of conduct failed because its implementation was flawed and didn’t address all ethical issues, most important being safety. With great diligence they fought to make all business transactions legit, thus denouncing scandals which was admirable, but to avoid addressing safety as an ethical issue is not above reproach. The first ethical question raised should be “is the product we are manufacturing safe to the parties we are soliciting?” If studies are performed findings should be disclosed on the label and not hidden. Safety not being on the ethics score card made the formal code of conduct vulnerable to controversy. Ok To make a product that may have safety issues without proper notification to the parties involved is highly unethical. The employee’s at Dow involved in the safety studies as well as the top level managers that made the decision to push the product were quite aware of the situation. The urge to generate profit and regain market share took precedent over any safety concerns.
In an effort to make the Code of Ethics more effective, a company such as Dow’s must address all ethical issue’s leaving nothing to chance. To the fullest extent any possible ethical dilemma the company could face should be analyzed and given a proper course of action. Yes Granted no society lives in utopia, thus no Code will be perfect, but at no point should major issues such as safety be brushed under the rug to obtain a profit. Companies must also be willing to be honest with themselves in addition to the parties that they serve. Doing so not only makes it easier to create an effective Code of Ethics but also implementing it will come with ease. In the Dow’s case they were not being honest about the product they were promoting and selling. Stemming from the early stages they knew the product had potential to be a safety hazard but elected to forgo the proper testing to ensure the product wasn’t detrimental to an individual’s health.

Breast Implant Helpline can help you with your breast implant claim
 

 

Silicone Breast Implant Lawyers, Silicone Breast Implant Class Action

Written by lisaspitzer on . Posted in Breast Implant Blog

Nationwide Breast implant helpline and Breast implant lawyers are helping women get compensation from the silicone Breast implant claims class action Recovery and compensation settlements.
Currently there are several class action lawsuits being filed by victims of defective breast implants.for Dow Corning, Mentor, Squibb, and others resulted in Lawsuits alleging such harm as cancer and autoimmune disease raked in millions of dollars throughout the 1990s, putting silicone breast implant manufacturers out of business or in danger of bankruptcy. With the assistance of “silicone doctors” who used minimal scientific evidence to support their claims, plaintiffs had stunning success. The wave of silicone breast implant lawsuits was largely a result of public opinion and aggressive pursuit of lawsuits by plaintiffs’ attorney, not medical evidence.

Dow Corning Brand Breast Implants Handled by Dow Corning Trust Facility (SF-DCT)

Settlements are currently handled for Dow Corning brand breast implants for Class 5 claimants as well as cases involving implants that contained silicone gel for Class 7 claimants. A product liability attorney will be able to explain the requirements for each of these defective breast implant lawsuits.

Funds are available for various foreign claimants and for those that received other Dow Corning manufactured products
The program offers settlement payments ranging from $2,000-$300,000 to eligible defective breast implant claimants until June 3, 2019.

The rules set up for breast implant litigation are very complex for the MDL-926, Revised Settlement Program and the Settlement Facility Trust of Dow Corning (SF-DCT). get help from a breast Implant helpline lawyer.

Speak to an experienced breast implant settlement attorney regarding defective breast implant claims or any other product liability cases for specific rules setup for product claims.

If you or a loved one are seriously injured or a death has occurred as the result of a defective breast implant or product, contact breast implant helpline and our breast implant lawyers to learn if you are entitled to legal compensation or have any questions regarding a breast implant registered claim.