Posts Tagged ‘New York’
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 email@example.com 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
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.
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.
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.
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
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.
Anatomy of a Crisis: One Perspective on the Silicone Implant Story
Clinics in Plastic Surgery, Volume 26, Number 1, January 1999
Note: Long after Dow Corning went bankrupt, the National Academy of Sciences stated there is no proven link between silicone implants and systemic disease.
Since 1977 our law firm has represented a national plastic surgery organization, the largest state plastic surgery association, and the largest physician-owned medical malpractice company in the country. We believed ourselves fairly well-informed on plastic surgery and its practitioners. By 1991, silicone had been in medical use for many years, and the utilization of silicone breast implants in augmentation and reconstructive surgery was both widespread and unquestioned. Surgeons were regularly assured by the manufacturers that the product was efficacious and safe. Between 1974 and 1989, only 99 breast implant-related cases were filed against Dow Corning, the largest manufacturer of these implants.1
It is estimated that between one million and two million women had silicone breast implants between 1964 and 1992.2 Questions regarding safety, for example, whether implants increased the risk of cancer to recipients, were addressed in reassuring studies, including the Deapen survey in 1986.3 This study found no increase in the risk of cancer among approximately 3,000 Los Angeles women with gel-filled implants. Doctors were advised that continuing manufacturer research had turned up nothing of concern. Patients were satisfied with results. In 1990, the American Society of Plastic and Reconstructive Surgery evaluated 600 detailed questionnaire responses and announced that 92 percent of breast implant recipients were well satisfied with the product and 82 percent would have the procedure performed again.4
A few contradictory signs, however, appeared. In March 1991, a New York jury awarded a plaintiff $4.4 million on her claim that her polyurethane implants caused cancer.5 The verdict was reduced to $1.5 million, but the case caused an awakening in the plaintiffs' bar. (Unlike silicone, polyurethane was regarded with skepticism by the medical community, and the polyurethane-coated implants were later taken off the market.)
Silicone implants had been in use before the Food and Drug Administration (FDA) was given authority to classify medical products; as part of the regulatory catch-up process, the FDA classified breast implants as a Class III device in 1988.6 This classification required pre-market approvals (PMAs) and also entailed safety testing for certain risk factors identified by the FDA. The manufacturers were given 30 months to provide safety data for PMAs, which they submitted in July 1991. This lengthy process was considered routine both in the FDA and in the medical world.
In November 1991, as part of the PMA process, the FDA convened a scientific advisory panel to study the safety and efficacy of silicone breast implants. The panel concluded that more research was needed but noted a lack of evidence of substantial risks. It recommended that implants remain on the market as a public health necessity because of their known benefits.7 The FDA set January 6, 1992, as the date for its decision on the approval and continued marketing of implants. No change was anticipated, and approval was considered routine. There was, however, an abrupt change in the projected scenario. As a result of media uproar, on January 6, 1992, the date on which the FDA was supposed to announce its decision on the approval and continued marketing of implants, Commissioner David Kessler announced a moratorium on the sale and use of silicone implants.8
What had happened? During the period in which the FDA had convened its scientific advisory panel to evaluate implants, noted television personality Connie Chung aired her famous "green gunk" segment with an intentionally ruptured polyurethane-coated implant. Her evaluation, intoned in the style of the witches' warning in MacBeth, over national television on November 8, 1991, predicted disaster for women with implants. No distinction was made between the polyurethane product and the silicone implant.
By itself, the Chung show would probably have been just another of the sensational TV "exposés" regularly presented for our edification. But on December 13, 1991, a San Francisco federal jury awarded Marianne Hopkins $7.5 million in her breast implant lawsuit against Dow Corning. Of this amount, $6.5 million represented punitive damages. The award was based on a jury finding that Dow Corning had "falsely and maliciously" failed to warn of the potential dangers of its silicone breast implants.9 The verdict made the front page of newspapers nationwide. The effect was immediate: Across the country, attorneys started drafting complaints.
On December 30, 1991, Dan Bolton, Ms. Hopkins' attorney, wrote a letter to FDA Commissioner Kessler describing certain documents and information gathered from the Dow Corning files pursuant to discovery orders and revealed during the Hopkins trial, which the FDA believed had been withheld from its November 1991 panel hearing. None of this information contradicted the basic finding of the FDA advisory panel. But it did encourage a number of television talk-show hosts to take up the subject enthusiastically. Almost every such show featured a silicone "victim" or a silicone "expert" who criticized implants. Sidney Wolfe, MD, head of the Public Citizen's Health Research Group, wrote to Kessler advising him to ban the silicone implants immediately rather than leave them on the market while safety studies were completed. Newspapers across the country reported these developments and the concerns about the implants.
On January 24, 1992, the first breast implant class action against both doctors and manufacturers was filed in Ohio.10 In February 1992 the FDA convened a second panel of experts to review new information, particularly the Dow Corning internal memoranda that brought about the Hopkins verdict. The FDA heard from a variety of medical practitioners, manufacturers, a number of plaintiffs and their legal advocates, and assorted "consumer" groups.
On a key point, the panel found that "there was not enough evidence to establish a cause and effect relationship between gel-filled breast implants and immune-related or connective tissue disorders—that is, it is not known whether women with breast implants are more likely to have those conditions than women without implants." The FDA concluded that more research was needed to prove the long-term safety of the product, although it recommended that silicone gel implants used after mastectomy and other limited uses constituted a public health need and that implants should remain on the market for these purposes.11
To help create a groundswell of support for litigation, plaintiffs' attorneys set up educational "seminars" in all kinds of meeting places. Not only could they create a tent meeting-like atmosphere to recruit plaintiffs, they were also able to recruit instant "expert" witnesses in connective tissue disease and a host of vague afflictions. Every such meeting meant a real increase in filed cases.
Just as the fascination of the media with the breast implant crisis fed the litigation mill, the glazed look in corporate eyes revealed manufacturers totally overtaken by events. In March 1992 a widely experienced and respected senior legal advisor to Dow Corning was quoted as stating: "Given the rapidity with which this has come on, I just have not formulated a good plan yet." As it turned out, Dow Corning never did. More significantly as a harbinger of the future, the CEO of that company said that implants accounted for only 1 percent of Dow Corning's $1.7 billion in revenues, but estimates of total liability claims ranged up to $2 billion.12
On the regulatory front, FDA Commissioner Kessler had convened two scientific panels, and on April 16, 1992, the FDA announced that breast implants with silicone gel would be available only through controlled clinical studies.13
Before the Hopkins case and the Chung show, a review of manufacturers' product complaint records submitted to the FDA as part of the PMAs had shown few, if any, complaints of autoimmune or connective tissue disorders from breast implants. Now there was a mushrooming epidemic. In January 1992 there were approximately 15 active silicone breast implant cases in California. By March 1993 approximately 700 implant cases had been filed in California. By October 1993 there were 2,300 cases filed in California.14
In Texas, just before Christmas 1992, Santa Claus appeared. A jury in Harris County, the most rewarding place in the country for plaintiffs' attorneys, awarded Pamela Johnson $23 million in her case against Bristol Meyers—$5 million for actual damages and $20 million for punitive damages. Following this verdict the Harris County clerk's office was swamped with new filings. During the week following the verdict 150 new cases were filed, and by the first week of January 1993 over 1,400 cases had been filed in Harris County.15
Plaintiffs' firms borrowed large amounts of money to increase their litigation attorney roster. Experts in attributing memory loss, aches and pains, and general malaise to connective tissue disease caused by silicone were retained.
Hardly a daily television chat show aired without a segment on this growing crisis. In June 1992 the CBS program "48 Hours" had one entitled "The Fear Within" featuring women with silicone breast implants complaining of their injuries and fears. It reported that one-third of the women who had their implants removed felt better afterwards. In the same month, a woman on "Larry King Live" on CNN told how she had attempted to remove her silicone implants with a razor blade because her insurance would not pay for the procedure. Jenny Jones, on her TV program, announced that she, too, was a silicone breast implant "victim."
Women's support groups, not previously considered sources of scientific information, were now widely quoted on breast implant horror stories and became a news source for interested media. The "Silicone Sisters," the "East Coast Connection of Breast Implant Survivors," and the "Command Trust Network" all distributed information on the dangers of silicone breast implants.
And the court filings mounted, in California and Texas particularly, but generally across the nation. In 1993, the manufacturers announced a $4.7 billion settlement offer, which was later revised. By early 1996, an estimated 450,000 women had received official court notice of the revised breast implant settlement offer. The total from the state court cases cannot be accurately tallied, but every indication is that there were thousands of such cases. By the end of 1994, more than 20,000 individual lawsuits had been filed against Dow Corning alone. In many of these cases the doctor was a codefendant. 16
There is no doubt that silicone triggers a hyperallergenic reaction in some women, and some women become very sick. But a true accounting of how many became sick before they had implants, how many attributed to the implants the pain, memory loss, and the general debilitation that comes with growing older, and how many were seriously affected by their implants, became lost in a sea of litigation. Thousands of cases were filed alleging horrible illnesses. Plaintiffs argued that the medical literature, chiefly Japanese, supported the allegation that silicone gel causes autoimmune disease. Our search of the journals reached a contrary conclusion. But why weren't cases filed earlier? Did everyone suddenly get sick at the same time?
After 44 years in both public law and private practice, I have concluded that frequently the search for truth in the legal process can resemble a bear peeling a grape. It takes a long time and is painful to watch. This proved to be true of the breast implant litigation.
The Doctors Company is the endorsed malpractice insurance carrier of the nation's largest plastic surgery association. While other carriers insure significant numbers of surgeons in various states, The Doctors Company has policies covering approximately 535 plastic surgeons across the country. Of this total, approximately three-quarters are in California and two-thirds of those are in southern California. Nationwide, between one and two million women had received breast implants, and informed estimates indicated 80 to 85 percent of these women had received them for cosmetic purposes.
The first cases indicated that California would be a very active litigation venue. While the early filings gave every indication of plaintiffs seeking damages from the doctor, it was difficult to predict how such issues as informed consent and closed capsulotomies might shift liability even further away from the manufacturers to the surgeon.
Even a conservative prediction of the total cost of the lawsuits, including defense costs, associated defense expert fees, potential indemnity payments, and other related expenses, would amount to a very substantial sum that could severely affect The Doctors Company. Two of the smaller manufacturers, Mentor and McGhan, had assessed their potential costs and decided to fund a settlement pool of millions of dollars to escape the expense of repeated trials. Before the Hopkins case, only a few lawsuits had been filed against Mentor. In the next year and a half, it was served with more than 1,000 cases. No one could predict what the growing number of suits against the doctors would eventually total.
Questions relating to the doctors' relationship with the manufacturers were paramount. Would the manufacturers stand by their product, which they had assured doctors was safe and effective? Would the disclosures in the Hopkins case poison defense efforts? Would there be a strong scientific response from the research community? What would objective scientific studies show? Would there be multiple state court actions against individual doctors, or state class actions, or a federal class action? What would the FDA ultimately do?
As for the largest manufacturers, it quickly became apparent that, unlike the plaintiffs who had formed steering committees to develop a common approach to the litigation, there was no shared strategy among them. Baxter made a decision to defend these actions aggressively and won most of its cases. Bristol Meyers, particularly in southern California, appeared to devote considerable resources to discovery and depositions only to settle on the courthouse steps. Dow Corning had no apparent strategy and was truly unpredictable.
Initially, we had briefly envisioned joining the manufacturers in a spirited defense of the product. That approach was quickly discarded after noting that the manufacturers' various defenses often included pointing the finger at the doctor. After surveying the early cases being tried, we made a decision to vigorously oppose any assessment of blame to the surgeons, who had not known of any doubts the manufacturers might have had regarding silicone implants. Participation in a number of meetings with respected research authorities left us dubious of the validity of the extreme claims made by the plaintiffs regarding the product.
What gradually became clear was that plaintiffs' attorneys in California wanted no part of the developing federal class action suit assigned to the very able and experienced Judge Sam Pointer. They believed that they had a much better opportunity in individual suits. If they sued the doctor together with the manufacturer, that coupling would defeat any manufacturer's efforts to claim diversity of jurisdiction and attempt to move the case to federal court, since the plaintiff and the defendant doctor both resided in California. In addition, state juries are generally more liberal in their awards than federal juries.
A second reason to push for individual suits was found in the most unfortunate June 1993 Supreme Court decision in Daubert v. Merrill DowPharmaceuticals. In that case, the Supreme Court, against the urging of six Nobel Prize winners and the New England Journal of Medicine decided not to limit the admissibility of "junk science" as expert testimony, and refused to adopt a "peer review" test. Previously, the "generally accepted" standard of admissibility articulated in Frye v. U.S. was used by many courts, including California, to determine the admissibility of "junk science." Now, each judge would act as gatekeeper on the admissibility of expert evidence under the much looser Federal Rules of Evidence. By filing individual cases, plaintiffs' attorneys obviously hoped to be able to bring in the travelling "experts" with their novel and often bizarre scientific notions.
A third reason for individual suits was to push the doctor-defendants into quick and lower settlements that could help finance the more serious legal effort against the manufacturers, which to the plaintiffs' attorneys was starting to look like the Aztec riches of Mexico as seen by Hernando Cortez.
What the plaintiffs' attorneys did not understand is that any significant malpractice settlement paid on behalf of a doctor must be reported both to a state medical board and to the National Practitioner Data Bank in Washington, both of which constitute significant blots on a physician's record.
It was clear to us at The Doctors Company that our response had to be fast and effective, and it was. With the invaluable help of The Doctors Company's medical director, Dr. Mark Gorney, a former president of the American Society of Plastic Surgeons (ASPS) who had great knowledge and insight into the issues surrounding the controversy, we were quickly able to persuade the officers and board of The Doctors Company of the need to spend a considerable sum of money on our defense efforts.
My associate, Norman Miley, who worked closely with me on this project, had sixteen years of trial experience. I had coordinated several large cases for the state of California and had once been chairman of a plaintiffs' steering committee in a significant class action. But it was clear to us that we needed someone to devote full time to the job of implementing and coordinating our defense efforts. We chose a very able trial lawyer with whom we had previously crossed legal swords. Despite having no medical malpractice experience, Marshall Cornblum was a brilliant choice. He came with no preset notions and with an analytical mind. He joined us in March 1992. We were in constant communication with him and met on a regular basis.
We decided to bring together our most experienced The Doctors Company defense counsel from the states most impacted by the litigation. These states ranged from Connecticut to Hawaii, but we expected the most activity in California. Later, we shared ideas and strategy with counsel from the other California carriers. The Doctors Company defense group first met in April 1992. A mass of journal articles and scientific studies was evaluated. A database of what was known and when it was known was established at one coordinating law firm office, Larson & Burnham in Oakland, California. A plastic surgeon, Dr. Jack Fisher, of the University of California at San Diego, and an outstanding rheumatologist, Dr. David Kneapler, were retained as consulting experts. We also engaged the services of Katherine Newman, an anthropologist from Columbia University, who is an expert on juries and jury selection. We hired an interviewer to question all the former Hopkins jurors that we could locate. Those interviews established several points. The jury had been puzzled by the voir dire conducted by Dow Corning's counsel, and they were enraged by the documents that clearly showed that Dow Corning's own employees seriously questioned its testing procedures. In addition, the jury ignored testimony from Ms. Hopkins' two treating physicians, presented by the defense, that her adverse disease symptoms were apparent before the implants were inserted.
At the first meeting of The Doctors Company defense counsel in 1992, we outlined Marshall Cornblum's role and that of Larson & Burnham. We reviewed the history of the breast implant "problem," the types of implants and changes in design, the adverse reactions that were claimed or established, capsular contraction, gel leakage, autoimmune disease, the present status of the litigation, pending individual actions, and the class actions. In this dense case review, tactical legal issues relating to filing answers to the complaints, potential cross-complaints, interrogatories, requests for the production of documents to be sent with the answers, subpoenas for hospital records and records of other known medical providers, responses to plaintiffs' discovery requests, document production by our defendant doctors and depositions were all discussed. Trial matters—jury instructions, a trial brief, motions in limine, voir dire issues and jury selection, the development of a trial theme and general litigation approach—and legal research matters—informed consent, product liability theories against physicians, statute of limitations, including the effect of the federal class action on the statute of limitations, and a host of ancillary matters—were set out in a detailed, seven-page agenda. It also provided for the development of a computerized document-management system for medical articles, FDA hearing transcripts, Dow documents, reporting and calendaring of court matters, action matters, and discovery matters.
After our first few meetings, we were quite sure that while the manufacturers might have had doubts about their silicone studies, the doctors never knew of them and, in good faith, relied upon the manufacturers' repeated representations that the silicone implant was not only a good product, it was a safe product.
But we needed to know what an average juror would believe. To that end, we obtained a courtroom in the Los Angeles Superior Courthouse on a quiet Saturday, February 20, 1993. Drawing from a jury list in Orange and Los Angeles counties, we assembled 60 persons in the courtroom and presented a mock trial involving a woman suing her plastic surgeon, alleging various sicknesses from a silicone implant. Our selected trial counsel also attended. We intentionally left out a manufacturer/defendant so that attention could be focused solely on the doctor.
Most of the themes developed during the mock trial followed the concerns voiced during the meetings with defense counsel. Expert witnesses for both sides included a plastic surgeon and a rheumatologist echoing the best plaintiff and defense points.
Afterwards, the 60 jurors broke into five groups of 12, together with a social sciences facilitator, to discuss what they considered important in reaching their decisions. Videos of their deliberations and of the trial itself were made. Katherine Newman oversaw the operation and on April 1, 1993, presented us with a 26-page summary of the mock trial jury findings. While there were quite a few surprises, the findings confirmed our basic defense strategy and gave us clear indications of the kinds of jurors who would listen to us and what arguments would convince them. Armed with this reassuring knowledge, we reaffirmed our commitment to the maxim: "Millions for defense, but not one cent for tribute."17
Gazing across the legal ramparts, we thought we understood what our legal adversaries in the plaintiffs' bar were doing. What we could not understand was what Dow Corning was doing. In early 1993, as the number of breast implant cases in California reached more than 2,300, the manufacturers announced a $4.7 billion global settlement.18 Terms of the settlement offered the more seriously affected plaintiffs more substantial amounts, but, incomprehensibly, there would be some payment for everyone in the action. Suddenly, doctors' secretaries, who had been quite pleased with their implants for 10 or 15 years, informed these surgeons, whom we represented, that they meant no disrespect to them, but they had to get in on a good thing, and so they joined the "lotto for ladies."
Rather than ameliorating the situation, Dow Corning's announcement increased the filings and whetted appetites. In May 1995 Dow Corning threw its hands up and its executives out and filed for bankruptcy.
Against this background, the plaintiffs' attorneys at first did not believe us when we said we would not settle for even a dollar, but gradually they learned of our preparation and our determination. The number of claims asserted against The Doctors Company reached 1,046. It was anticipated that hundreds of additional cases would be filed by lawyers who were awaiting developments and The Doctors Company's reaction to the first cases before filing their actions.
Slowly, the tide receded. The claims that had not been filed were never filed. Cases were dismissed by the score. And, while a few remain in the court docket, chiefly outside California, we do not believe they constitute a real threat. The cost of this preparation was nearly $7 million, chiefly in payments to trial counsel to work up defenses for the accused doctors.
What is important, however, is that no judgment was ever entered against any of our insured doctors. Of more than 1,200 reported incidents, only two plastic surgeons insured by The Doctors Company have gone to trial over the breast implant crisis to date; both cases resulted in verdicts in favor of The Doctors Company insureds. I submit that our strategic response, while expensive, was very effective. The Doctors Company had put up actuarial reserves of $30 million against what was originally thought to be a dire threat to its very existence. That was based on a cold actuarial analysis.
As George Bernard Shaw wrote: it is not the experience that matters, what counts is what you learn from it. What have we learned?
Scientific studies had no impact on legal filings. As the evidence mounted and prestigious institutions, such as Harvard and Johns Hopkins, and others in the United States and Europe, reported widespread evidence that there were no data to support the silicone-sickness frenzy, the media finally stopped its anecdotal reporting of an epidemic. Their reports came too late, however, to affect the filed cases, which continue to have a life of their own. In 1992, our esteemed consultant asked in the New England Journal of Medicine "When will science prevail?"19 In the legal world, the answer would appear to be, not soon.
We know what this cost The Doctors Company. What it cost the manufacturers is undoubtedly much more. There are now very limited options for women who want silicone breast implants. Those who left the field, including the manufacturers of raw materials for jaw implants and other prostheses, are not likely to return.
Any problem in new and promising technology may be seized on as a threat to human survival. Witness the sorry spectacle of what happened with pedicle screws. Watch what is happening to the Norplant birth control device. The future for medical devices that might improve certain human physical conditions does not look bright. The trend towards mass litigation, mass recruiting of "victims," quick consolidation into class actions, and the push towards industry settlements to avoid huge legal defense costs are likely to lead to overseas manufacturing in areas less blessed with our tort system and subsequently with far less development of new products in the United States.
Unless we learn the lesson of what this legal system costs, we are bound by Santayana's dictum, "Those who cannot remember the past are condemned to repeat it."
Anonymous (attributed to Public Citizen), 1992 Silicone Implant Clearinghouse, reprinted in Breast Implant Litigation, New York: Law Journal Seminars Press, 1992, pp 115, 159.
House Committee on Government Operations Staff, The FDA's Regulation of Silicone Breast Implants, 102 Cong., 2nd Sess., Washington, DC: Comm Print, 1993.
Deapen, D.M., Pike, M.C., Casagrande, J.T., et al: The relationship between breast cancer and augmentation mammoplasty: An epidemiologic study, Plast Reconstr Surg 77:361-7, 1986.See also Berkel, H., Birdsall, D., Jenkins, H., Breast augmentation: A risk factor for breast cancer?, N Engl J Med 326:1649, 1992.
American Society of Plastic and Reconstructive Surgeons, Inc., Press release, November 19, 1990.
Livshits v. Natural Y Surgical Specialties, 87 Civ. 2403 (S.D.N.Y.).
53 Fed. Reg. 23, 862 (June 24, 1988).
U.S. Department of Health and Human Services, FDA Press Office release, November 14, 1991.
U.S. Department of Health and Human Services, FDA Press Office release, January 6, 1992.
Breast Implant Litigation Reporter, Andrews Publications, March 1992, p 10. See also Griffin, W., Emerging issues in breast implant litigation, American Bar Association, 1993.
Dante v. Dow Corning, Class tentatively certified by federal court in Cincinnati. Reported in Breast Implant Litigation Reporter, March, 1992, p 3.
U.S. Department of Health and Human Services, update on silicone gel-filled breast implants, FDA news release, February 27, 1992.
McKennon, Keith, quoted by Breast Implant Litigation Reporter, Andrews Publications, March, 1992, p 14.
News Release Update on Silicone Gel-Filled Breast Implants, May 25, 1992.
Medical Legal Aspects of Breast Implants, Leader Publications, October, 1993, p. 8.
Medical Legal Aspects of Breast Implants, Leader Publications, January, 1993, p. 4.
Hazelton, Dick, quoted in transcript of Frontline, February 27, 1996, WGBS Educational Foundation, p. 10.
Adams, John (attr.), reply to Talleyrand in XYZ Affair concerning French seizure of American ships.
Medical Legal Aspects of Breast Implants, Leader Publications, September, 1993, p. 1.
Fisher, J., The silicone controversy—when will science prevail?, N Engl J Med 326:1696, 1992.
About the Author
Charles O'Brien, LLB, Board of Governors, The Doctors Company, Napa, California
The Breast implant Helpline is here for you if you are one of the women injured by the silicone Breast Implant Class Action lawsuit. We can help you locate a Breast Implant Lawsuit lawyer.
Colleen and John Swanson
Dr. Joy Taylor
“There was no negative information given to me at the time to say that they could affect my health in any way. It was the solution and he told me quite frankly this will last you for the rest of your life….You’ll never have to wear a bra again in your life.”
For many years, Audrey Ciancutti has suffered from illnesses related to her ruptured silicone breast implants. A native of Pittsburgh, Pennsylvania, and mother of filmmaker Carol Ciancutti-Leyva, Audrey is the inspiration of the documentary ABSOLUTELY SAFE. Today, despite her illness, Audrey is an active and committed advocate for breast implant safety.
Audrey’s relationship with silicone began in 1974, when she was diagnosed with breast tumors and advised by her doctors to have a double mastectomy and silicone-implant reconstruction surgery. Within a year, Audrey’s implants had ruptured and her doctors replaced her old implants with new silicone implants which also eventually ruptured. In the years since her multiple ruptures, Audrey’s health has steadily declined. Unexplained rashes, severe joint pain, chronic fatigue, crippling arthritis, and lupus—all of these mysterious, debilitating conditions entered Audrey’s formerly healthy life.
As Audrey learned more about silicone implants and other women who had developed similar conditions after their ruptures, Audrey concluded that her implants and the ruptured silicone migrating throughout her body were making her sick.
Although Audrey’s last set of ruptured implants were removed over twenty years ago, she continues to suffer from severe joint pain and fatigue.
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“The feeling that I’m expecting to get from that [breast implants] is just more confidence, and to feel better in my clothes.”
“…I love Jessica Simpson, I watch MTV, and I guess maybe because it started at such an early age, those were the people I wanted to look like, or be like…”
Deneé Dimiceli is a healthy, vibrant, and happily married young woman who lives in Houston, Texas. Ever since she was a teenager, however, Deneé felt incomplete and yearned for larger breasts. Over the years, Deneé battled her breast size insecurity with all sorts of products–padded bras, water bras, air bras, tissue, and rubber falsies she called “chickens.” In her twenties, Deneé began to save money for breast implants calling it “her boob job fund.” Finally, at the age of twenty-seven, Deneé decided to have breast augmentation surgery.
The decision to have breast implants was not a difficult one for Deneé, but it was difficult for her husband. Deneé’s husband T.J. had concerns about her surgery and did not want his wife to have breast augmentation, saying “I think they’re just fine the way they are.”
Although her husband did not fully support her decision and had questions about implant safety, Deneé did her own research and concluded that the risks were worth the chance to feel better about her body. With the help of Dr. Franklin Rose, one of the most respected and experienced board-certified plastic surgeons in Texas, Deneé’s dream came true—she became a “a full C” with saline implants and now “feels more like a woman.”
Today, nearly two years after her implants, Deneé remains happy and healthy. Although Deneé did lose some sensation in her nipples and her husband describes her breasts as “not feeling natural”, she still believes that implant surgery was the right decision for her.
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“They feel alien to me. I don’t want them in my body. I look at them as sacs of poison in my body.”
“I went to the original doctor and he basically told me there’s nothing wrong with silicone and it sounded like he had given this speech a million times before…he’s telling me it’s all in my head, and there’s nothing wrong with silicone.”
Wendi Myers had breast augmentation surgery with silicone breast implants in the 1980s.
During the late 1990s, Wendi began complaining of dizziness, fatigue, joint pain, hair loss, and nipple discharge. Like many other women who believe that their implants have made them sick, Wendi had been a healthy and energetic woman before her mysterious illnesses emerged. Wendi believes that her health problems all began when her implants ruptured in a car accident. Although numerous doctors assured Wendi that her implants were not ruptured and could not possibly be making her sick, Wendi maintained that her implants were indeed ruptured and responsible for her illness. Repeatedly, Wendi was told by doctors that her illness “was in her head.”
In 2006, Wendi met plastic surgeon Dr. Edward Melmed, the first doctor who acknowledged that breast implants can cause illnesss. With the financial help of her mother and the surgical skill of Dr. Melmed, Wendi had her implants removed in 2006. During the surgery, Dr. Melmed discovered that both of Wendi’s silicone implants were, in fact, severely ruptured.
Today, Wendi is a successful graphic designer and advocate of implant education and safety. She hopes that sharing her story with the public will help educate and inform other women about breast implants.
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Dr. Edward Melmed, MD
“They do not last. They rupture. And the longer they’re in the body the more likely they are to rupture. The statistics are kind of scary, because around about 50 percent are ruptured by 10 years. And when it gets to 15 to 20 years you’re looking at almost 90 percent of implants that are ruptured.”
“What is most worrisome is that while most of the silicone is contained within the capsule, some of it leaks out, we don’t know where it goes, we don’t know what it does, we have no idea.”
Edward Melmed is a board certified plastic surgeon . He has been doing plastic surgery for almost 40 years. Dr. Melmed is certified by the American Board of Plastic Surgery. He is also board certified in England, Scotland, and South Africa.
Dr. Melmed is unique among board-certified plastic surgeons working in the United States. In addition to being one of the few plastic surgeons to publicly question implant safety, and criticize the long-term problems and complications, Dr. Melmed is also one of the few plastic surgeons who removes implants without replacing them. He has demonstrated that this can be done safely and with excellent aesthetic results.
In the early years of the silicone debate, he, like all other plastic surgeons, did not believe that problems existed. After all, the manufacturers told plastic surgeons that implants would last a lifetime. In 1992 he started seeing women with problems almost all of whom had common symptoms—severe fatigue, short-term memory loss, joint and muscle pains, hair loss, etc. Seeing and treating women of all ages, and all walks of life who had these symptoms in common convinced him that there was a problem.
In the film ABSOLUTELY SAFE, Dr. Melmed maintains that implants have three major long-term problems—rupture, encapsulation which is a natural reaction to all foreign material, and in a certain percentage of women, symptoms from reaction to silicone.
During the film, Dr. Melmed meets Wendi Myers, a patient who suspects her silicone implants are ruptured and making her sick. Wendi’s symptoms of fatigue, hair loss, and dizziness are like those of other patients with silicone implants. Dr. Melmed removes Wend’s implants with no replacement. In surgery, Dr. Melmed finds that Wendi’s implants are severely ruptured.
Dr. Melmed believes that current implants have severe flaws that worsen with time. With the reintroduction of silicone gel, the manufacturers even agreed to recommend removal and exchange every 10 years, and MRI examinations every 2-3 years. He is extremely worried about the future of young women who have implants when in their teens or early twenties.
In his spare time, Dr. Melmed volunteered his time to head the Dallas County Gang Tattoo removal program. He is always busy restoring antique cars (he tells people his occupation is working in a body shop) or riding his motorcycles.
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Dr. Franklin Rose, MD
“This is a safe bio-material that reputable, ethical, board certified plastic surgeons are placing in individuals who want a well performed operation. Every scientific study that’s done by Mayo [Clinic], by Harvard, by the plaintiff’s attorney’s own judge shows it’s safe. It’s a safe implant.”
Dr. Franklin Rose is one of the most experienced and respected board-certified plastic surgeons in the United States. During his 18 year career in Houston, Texas, he has performed over 4,000 breast augmentation surgeries.
Dr. Rose has a special interest in facial and hand procedures, breast augmentation and reduction, and liposuction. In addition to two research grants he received from the American Society for Aesthetic Plastic Surgery, Dr. Rose is the recipient of several distinguished awards from the Plastic Surgery Educational Foundation.
For Dr. Rose, his stance in the breast implant debate is clear—he believes that breast implants, both silicone and saline, are safe products whose safety have been repeatedly proven by studies conducted by respected organizations such as the Mayo Clinic and Harvard University. Although, Dr. Rose is aware that the silicone implant controversy continues, he remains confident in their safety. Following the FDA guidelines, Dr. Rose continues to augment women’s breasts with both silicone and saline implants.
In the documentary ABSOLUTELY SAFE, Dr. Rose performs saline implant surgery on his patient Deneé Dimiceli. Throughout his conversations with filmmaker Carol Ciancutti-Leyva, Dr. Rose remains committed and confident that implants are safe and effective.
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Dr. Michael Harbut, MD, MPH, FCCP
“I think that the science on the implants has been so discouraged from actually being undertaken in a coherent and realistic fashion that we really don’t know much about these devices at all.”
“The occupational medicine literature is emphatic in its opinion that at no stage should a worker be exposed to any liquid or solid containing any platinum salt.”
Dr. Michael Harbut is one of the most preeminent occupational and environmental health physicians working in his field. Dr. Harbut was awarded the “Broad Street Pump Award” from Physicians for Social Responsibility for his work to lower the arsenic levels allowed in American drinking water. Internationally renowned for his research regarding the link between toxic exposures and disease, Dr. Harbut was awarded the Selikoff Lifetime Achievement Award by the Asbestos Disease Awareness Organization in 2007. As Co-Director at the National Center for Vermiculite and Asbestos-Related Cancers at the Karmanos Cancer Institute, Dr. Harbut’s team developed what is considered one of the most important blood tests for cancer ever discovered. His team’s groundbreaking research was published in the New England Journal of Medicine. Additionally, Dr. Harbut has consulted for Public Citizen, testified before the United States Senate regarding the diagnosis and treatment of asbestosis, been invited to speak at the Whitehouse, and been featured in author Andy Schneider’s book An Air That Kills.
Dr. Harbut has treated over 1,000 women with breast implants and believes that platinum and other potentially toxic heavy metals used in the making of silicone gel and silicone shells in breast implants can cause or contribute to serious disease and illness in breast implant patients.
In ABSOLUTELY SAFE, we meet Dr. Harbut and one of his patients Dr. Joy Taylor. Dr. Taylor, once a healthy, vibrant, successful, and active woman is now seriously ill with pleurisy and respiratory disease. According to Dr. Harbut, Joy’s illness is the result of “a clear sensitivity or allergic reaction to silicone and/or components of silicone” in her ruptured silicone implants.
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Dr. Ernest Lykissa
“The IOM and the manufacturers have never approached it by looking at implants that have been taken out of women, after five years of implantation, and studied those…that’s the difference between what I do and what they do. I’m looking at failed devices.”
Dr. Ernest Lykissa is a forensic toxicologist with over 25 years of experience. Dr. Lykissa’s commitment, dedication, and passion for breast implant research is remarkable and has sparked other scientists to enter the chemical debate about breast implant safety. Many women with breast implants and their doctors have turned to his lab ExperTox for chemical analysis of blood, urine, and tissue samples.
For over a decade, Dr. Lykissa and his colleagues have performed chemical studies on failed breast implants. According to Dr. Lykissa’s studies, breast implants leak platinum into the body and a toxic form of platinum (a charged, oxidized form) may be the cause of the illnesses some women with breast implants suffer.
Dr. Lykissa’s research is not without controversy, as many other scientists have criticized the research methodology and findings. While the IOM and the FDA have reviewed Dr. Lykissa’s studies, the FDA maintains that the platinum research is inconclusive because the studies were flawed. For more information on Dr. Lykissa’s platinum research visit the “Platinum Salt Theory” section of this website.
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Executive Editor, Business Week
“All you have to know is one simple thing. The manufacturer never proved that the devices were safe and effective, because they never did the due diligence, the work that was necessary in clinical studies, and in scientific discovery, to make that assumption, and to make that conclusion. And that at the very base of this debate is what has to be done.”
John Byrne is one of the most respected and accomplished business journalists working today. As Executive Editor of Business Week magazine, former editor-in-chief of Fast Company magazine, and veteran writer at Business Week for nearly 18 years, Mr. Byrne has written countless articles, cover stories, and eight books on business, management, and leadership. His book on General Electric CEO Jack Welsh, Jack: Straight from the Gut, was an instant bestseller.
In his acclaimed book Informed Consent, Mr. Byrne investigated the complex story of Dow Corning and the silicone breast implant safety controversy. Framed by the stories of Dow Corning executive whistle-blower John Swanson and his wife Colleen Swanson, who fell quite ill from her Dow Corning made silicone implants, Informed Consent tells the riveting and disturbing tale of personal and corporate crisis. Through the stories of the Swansons and extensive research on Dow Corning, Mr. Byrne raised profound questions about government regulation, corporate responsibility, and the very notion of what “informed consent” means in an age of million dollar advertising campaigns for billion dollar products like breast implants.
Despite the Dow safety cover-up, lawsuits, silicone implant sale restrictions, and years of FDA hearings, breast implants and the cosmetic surgery industry as a whole have boomed over the last decade. As Mr. Byrne explains in the film ABSOLUTELY SAFE, the conflict between government regulation and professional ethics still taints the breast implant safety debate. In commenting on the FDA advisory hearing to approve silicone breast implants Mr. Byrne notes “the panel voted nine to six in favor of silicone breast implants. Four of the nine “yes” votes were by plastic surgeons who shouldn’t even have been sitting on the panel because of their obvious self-interest.”
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“The doctor says you have breast cancer. You need a mastectomy, you need radiation, you need breast implants. It’s like part of the whole treatment. In reality I didn’t need the breast implants to get over the cancer. But they make it seem like it was all part of the recovery. It was a terrible thing.”
Breast cancer survivor Anne Stansell is one of the most active and inspirational voices speaking out against breast implants today. In addition to sharing her story and testifying at numerous FDA hearings, Anne has also exhibited her powerful and beautiful collection of photographs to FDA panels. Anne’s photographs document the bodies of everyday women whose breast implants failed, causing complications, sickness, and disfigurement.
After surviving breast cancer at the age of 39, Anne’s doctors told her that along with her mastectomy and radiation therapy, she needed silicone breast implants. Presented as part of the standard treatment and not as a choice to consider, Anne trusted her doctors whom she felt “had just saved her life.” At this time, Anne did not know that breast cancer patients with breast implants had not been fully studied.
Five years after getting her implants and recovering from cancer, Anne became very ill. Her symptoms were unrelated to past cancer and presented ailments she’d never experienced before. Diagnosed with Grave’s Disease and Fibromyalgia, Anne also suffered a torn retina from severely dry eyes.
After battling her insurance company to help with the expense of implant removal, Anne had her implants removed two years later. Upon ex-plantation, doctors discovered that half of one of Anne’s implants was missing. During her FDA testimony, Anne asked “where did the silicone go?” In the coming years, Anne found silicone in her side, where it had eventually migrated. Like many other women, Anne’s health improved after her implants were removed from her body.
Today, Anne leads a support group in Albuquerque, New Mexico, for breast cancer patients who have had similar experiences with breast implants. Anne continues to speak out against breast implant use in cancer patients and lobbies the FDA to require more extensive research on breast implant safety for all populations. Anne’s voice and creative eye are an inspiration to thousands of women in the breast implant safety debate.
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Colleen and John Swanson
“Profit. Money. These are profitable devices. People make money on them. They want them out there. There’s a market for them.” –John Swanson
“I said, ‘If I have to take these out myself with a razor blade, they’re coming out.’ I said, ‘We can do this secretly. We can go someplace where nobody knows us. Dow Corning will never have to know.’” –Colleen Swanson
Colleen Swanson and John Swanson have been in the epicenter of the breast implant safety debate in more ways than one. As a long-time employee at Dow Corning Corporation, formerly one of the largest manufacturers of silicone breast implants, John Swanson helped lead the company’s ethics policy, and at times, was involved in the company’s private and public defense of silicone implants. In the midst of the heated public controversy regarding breast implant safety, John’s wife, Colleen Swanson, privately believed that she, like thousands of other women believed, was sick from her silicone implants manufactured by Dow Corning.
In ABSOLUTELY SAFE, John and Colleen share their story of personal and corporate crisis. Assured by experts at her husband’s company that breast implants were safe, Colleen Swanson had breast implants put in her chest in 1974. Immediately, Colleen began to suffer from unexplained health problems. After nearly seventeen years of suffering from mysterious symptoms associated with lupus and scleroderma, Colleen Swanson made a radical decision regarding her implants—she wanted them out of her body forever. As she explains in the film, expressing her belief that her implants caused her illness risked her marriage and John’s career. John was a company man in the company community of Dow Corning. Colleen was adamant, however, and had her implants ex-planted. Upon removal, Colleen’s doctor discovered two severely ruptured implants; her rheumatologist connected all of her symptoms to the silicone gel implant ruptures.
Faced with a “huge corporate sense of denial” and a beloved wife who was severely ill and convinced that her implants were the cause, John Swanson ultimately stopped towing the company line and took his wife’s side on the issue. In 1991, after 26 years at Dow Corning and believing that the company’s popular product—silicone breast implants—were safe, John Swanson recused himself from participating in the company’s decision to continue to sell silicone breast implants.
The Swanson’s story is thoroughly told in the acclaimed book Informed Consent by Business Week Executive Editor John Byrne. In addition to offering the corporate context of the breast implant controversy, the story of Colleen and John Swanson provides a revealing window into the toll that the safety debate takes individuals, both men and women. Ultimately, Colleen and John’s story stands as a metaphor of everyday people—including thousands of women like Colleen and their families—who are caught in the dangerous, confusing traffic jam of corporate greed, health, and personal courage.
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Dr. Joy Taylor
“I was a practicing physician until two years ago. And I had to finally go on disability because I was just not able to function any longer on the job. I’m here because I have become very ill from my silicone implants. I had them in when I was 30 trying to save a bad marriage, and it didn’t work anyway.”
Dr. Joy Taylor has spent the last decade suffering from illnesses that she and her doctors believe are caused by her ruptured silicone breast implants. Once a healthy, vibrant, active, and successful professional, Dr. Taylor is often too sick to get out of bed.
Ten years ago, Dr. Taylor developed severe respiratory problems and was diagnosed with pleurisy. During a CAT scan, doctors discovered that her breast implants were ruptured. Two years later, Dr. Taylor’s health continued to decline and she was forced to leave her profession because she could no longer function on the job.
Dr. Taylor’s doctor, Dr. Michael Harbut, describes Joy’s story as one of the best examples of how implants can make women sick. As a “bright, energetic” woman who was “engaged in life, engaged in her profession,” Dr. Taylor had “a deeply vested interest in being able to be active and healthy.” According to Dr. Harbut, Dr. Taylor’s health crisis is caused by a “hypersensitivity or allergic reaction to silicone and/or components of the silicone in Joy’s breast implants.”
Today, Dr. Taylor continues to suffer from health problems. Although she had her ruptured implants removed, both migrated silicone and platinum remain in her body.
Breast Implant Helpline is always looking for sories to share with our readers regarding the Mentor, Dow Corning Breast implants, others. Women have had theor live ruined by auto immune diseases. Here are some of their stories.
saw breast implants turn my ex-wife (she had them when we married) from an active, fit athletic individual to a woman who can barely climb stairs or stand on her feet for a prolonged period of time. They are a terrible product whose marketers capitalize on the insecurities of woman who have been made to feel inferior because they don't look like they've stepped out of PLAYBOY!
I am a 3rd year medical student, struggling to get through the physically rigorous clinical clerkships (I am a good student– scored in top 5 % on national boards) because of chronic fatigue syndrome (CHANGE THE NAME!) and fibromyalgia. These illnesses began in 1993, 4 years after I had Mentor silicone breast implants put in. For years, I pooh-poohed and exercised denial regarding the risks of silicone. But once I opened my eyes and saw that the complaints of women with SBI were the SAME as MINE,
I began to frantically dig through the scientific literature. I was and am deeply disturbed that proper studies of the risks have yet to be done. The Mayo clinic has just perpetrated an unforgivable crime on the medical and scientific world by publishing their most recent study on "local complications" of SBI, in which they FORGET to say that their prior (much quoted by implant manufacturers) study of "classical" connective tissue disease and SBI DID NOT EXAMINE THE RISK of "non-classical" diseases, eg CFS and FM (the very illnesses most often claimed to be related to SBI, and the FORGOT to tell the reader than their sample size was too small to find even a doubling of risk of the rare disease scleroderma. Maybe their selective memory was related to the support they received from implant manufactur- ers? (This support is acknowledged on the first page of the article). Worse, to me, is that the NEW ENGLAND JOURNAL OF MEDICINE would publish this article with its clear corporate bias in place.
I have seen sufficient evidence in the scientific and medical literature to convince me that there is a real and likely possibility that silicone can cause immune related disorders. That proper epidemiological studies have not yet been done is NOT PROOF that there is no problem. Opponents of silicone disease theory cite the "monetary motivations" of the sick women.This ignores the fact that a lot of these sick women have lost their livelihood and have to fight tooth and nail just to get meager disability benefits. For the vast majority, significant compen- sation from implant manufacturers remains a distant dream (Dow bankruptcy) or impossibility (Mentor settlement allowed a maximum of $1500 compensation per patient–doesn't even pay the cost of explantation).
As an "implant victim" I don't expect to reap millions. But I would like knowledge about silicone related disease to be viewed objectively, so that thousands of people can get appropriate medical care, support and disability benefits, and so that research can begin on TREATMENT for these illnesses.
I think they make many people sick. I think it takes years for most women, but some react with in the first couple. I know in my case it was the chemicals. I have a intense chemical sensitivity that started with in a year after implantation. My body was trying to tell me something. I had all these allergies very suddenly, that I never had before. I know it took years (9) years to trigger full-blown fibromyalgia and 10 to put me into sudden unexplainable menopause in 2 months time. I have had them out for several months and am feeling a little better. It will take me years to repair the damage done to who all knows what and just hope my body will heal itself with taking care of myself and good wholistic medicine. Any one reading this thats thinking about doing it really research it. I'd give any thing to go back 12 years ago and do it over. I miss my active healthy life style. I miss feeling good. It takes many years for it to wear you down. Your always sick or aching but you just don't make the connection until they rupture and you can't eat food because your so allergic to every thing. The body aches (fibromyalgia) make it impossible to exercise like you use to. Just really think about it. I found out breasts weren't worth the price I paid. I think I would have been better off to have never had them, it was devastating to have to make that choice of should I explant or not. They build your self image only to tear you up in the end. Invest in those inserts for your bras. They are damn near the same thing only you won't be exposed in such a toxic way. Last but not least. Teach your sons and daughters the cup size of a woman is not nearly as important as your soul and heart. I wish I would have had not taken to heart all the cruel flat-chest jokes and comments I endured in my life. It cut deep and I made that fatal mistake of falling for the scam of a womanly body image. I will always feel less of a woman because of the standards we are faced with on a daily basis. Of course we all know 75% of the are augmented any way. Just think carefully and open your eyes up.
Thanks for listening.
My Dow corning Implants were removed May 1992, My good days are fewer and fewer. All the doctors I have seen, just thinks that I have inherit these diseases. There is no getting well from the destruction the Dow Corning Breast Implants have done to all of us.
I had mastectomies at the age of 29. I thought that implants were a God send. Now I feel like an idiot. I have been very ill for over four years. Wish that someone would believe us so we could get the funding for research to find a way to get better. At the age of forty, and once being a workaholic and owning my own business, its a hard pill to swallow that my main goal now would to be to be able to hold my three month old granddaughter pain free! Just so I could fully enjoy her. I know that there are so many of "us" that are worse off than me. But I see a drastic change from year to year. The others that I have talked with have told me that it took anywhere from three to five years to feel better after explantation. Well, it's been four years for me and I have gotten progressively worse. But through talking to others, and reading all of the newer reports that are out, we (myself and family) have come to the conclusion that even though I have had my silicone implants removed, I did have them replaced with saline. Now we have come to learn that the envelope holding the saline gel is made of silicone, and over time the envelope will break down and fragements will migrate through the body. Which would certainly explain why I have continued to worsen, when I should have been getting better. So ladies, if you are considering saline implants, please do not trust your doctor. Just read the new abstracts and other reports, and I do believe you will make your own conclusion. My mastectomies were a very serious operation. But I must tell you that the explantation was much more severe, and took much longer to recover from. You loose feeling and cant wash or feed yourself for quite awhile. You will loose muscle, lymphnodes, breast tissue (if you have any), and they must remove the capsule. The recovery is unbelievably painful. Now I have to go through this again. I am scared to death! If you feel that it is worth going through this sever operation over and over again, then by all means, have the implants put in. You have so much to look forward too! Thank you for the opportunity to spout off. Best wishes, Lori ______________________________________
Well my mother has had implants since 1982 and she is now suffering many different ailments which her doctors are saying are a result of the implants, So as you can probably guess I am not a supporter.
El Paso, TX
Women should be discouraged from having ANY form of implant as they are not safe. I had silicone for thirteen years and both had ruptured. No-one told me that they had a limited life span or that they contained a lethal chemical cocktail which would be absorbed into my body. I am totally digusted at the medical professions unwillingness to verify what many know to be true – we are sick and they know it. Until some decent doctor stands up with irrefutable proof that we are ill with atypical diseases then we are stick with being labelled neurotic idiots. The manufacturers have a lot to answer for and one day they will.
The past implants have caused women many problems including myself. I think that the saline filled implants are safer but once again there is the bag that holds the saline. Who really knows?
I do not have enough information on the matter to make a conclusion. I would like to know more about the possibilities of Soy Bean implants and if they will be approved in the US. I hear you can still get mammograms with the soy bean implants. How dangerous are the saline implants? You don't hear much abouth those. It's really great that you have this website to help people become more knowledgeable..
I am trying to get information for a research paper on breast implants. I would greatly appreciate anyone e-mailing me on any personal information or facts that you have about breast implants. Thanks
As we search for information on our Journey to Justice, we are bound by all that is morally right to stop the wholesale poisoning of thousands more women. Our young girls are being taunted and teased with the "bimbo" image. Young woman, when the plastic surgeon says he can change your live and turn it around, he is serious. Before long, you will be in our shoes and there will be days when you will feel fortunate to crawl. I cannot turn back the clock and regain my health but I can do my part to insure another generation of women do not suffer as we are doing today. Your plastic surgeon's interest in your health ends at your purse. How else could he have the ocean front summer home, climb mountains in far away countries, and drive a Mercedes?
I have had silicone implants since 1973. There is no doubt that they make you ill.I was in the mdl until dow filed bankruptcy. My records disappeared a long time ago. I am trying to prove that i had dow and do not know how to do that. I don't know how many other women out there have this problem. I would like to hear from someone that may have any info that would help me. For years I have been ill. For years I was told it was all in my head. In 1993 I had them replaced with silicone[I know] the m.d. had to scrape with hands ,etc. to collect all the spilled silicone. I certainly would not have replaced them had I been awake to see that The info at that time was scarce and I trusted the m. d. afterall it was always in my head.Thank you any help would be appreciated.
As I have previously said, this is the worst disaster on the human life since the Vietnam War. We women have been mentally and physically raped by this disease and the manufacturers, especially Dow! I have been sick for over 10 years, and I had the junkiest, dirtiest, Dow implants inserted into my body in 1975. I was a nurse, had a mastectomy, and I believed in our FDA, our doctors, and that we were protected from product problems. I and countless other women were fed lie after lie! I live in a small town, where I grew up, and am now 50 years old, and cannot be treated at the hospital where I once worked as a nurse. All due to the bad publicity, and the cover-up by Dow. I truly believe that all the men involved in making these implants, all the executives, their lawyers, etc. should agree to let me inject 40cc. of this very toxic silicone into their bodies, I really don't care where,( but I could think of some great areas) and then Mr. Hotshot, you must leave them in for 7 years, no matter how sick you get. Then you must beg someone to help you because you want them out yet you can't afford the surgery. Then your wife leaves you because you can no longer work, and you feel so bad that your a bore to be around, and guess what? Everyone thinks your crazy! Now the place in your anatomy that I was thinking of injecting this toxic silicone into you is a place that has deformed you so that you no longer feel like a man, and can't function as one either, so now your wife is GONE! You now lose your job, your nerves are shot, you can't even open a beer bottle! You are trying desperately to get your social security disability and they are taking their own sweet time. Meanwhile medical bills are piling up, you loose your house, you start selling your gold, jewelry, furniture, sell your car(and settle for just wheels to get to the Dr. and back). You can't sleep at night, you have pain in all parts of your body, you have to go through painful neurological testing to determine how much silicone is in your bra! in. People look at you like you did this just to look better, they tell you that no one would put silicone into your body if it wasn't safe. You see all they have to read and see on TV. is what YOU PAID TO BE SAID OR PRINTED. You LOSE, AND YOU ARE GOING TO DIE FROM YOUR CRUEL GREEDY, GAME. When this 40 cc. of silicone that I have in my body, finally does enough damage to cause my death, I know where I am going for eternity because I am a Christian and I will be in heaven with all my other silicone sisters and children. But God already has a plan for you and it won't be in heaven! You have mutilated, maimed, and yes killed us women and now children. You don't mess with God's handiwork. May God have mercy on your evil, greedy, lying soul!!!
I had Dow Corning imparts put in in 1974. I was a healthy 32 yr. old woman who just wanted to look my best. 4 years later I had colon cancer and I've had Systemic Lupus since. I have had 12 surgeries for various adhesions and nerve entrapment. I had the implants removed in 1994. Up until that time no one would admit it could be the implants causing any problems. I must take Prednisone and Plaquenil, plus many other drugs and narcotic painkillers every day. If I had only been given even SOME of the facts, I would have never even considered these terrible products. It was indeed a tragedy and a con job on American women.
I have had silicone implants since 1987. Diagnosed with SLE in 10/96. Currenting negotiating with insurance company for explantation. My biggest complaint of this whole mess is "informed consent". We should have been informed as to what possible/probable debilitating effecting silicone implants would have on our bodies before we made the decision to have them. Thanks for listening
Breast Implant lawyers are helping women with silicone disease claims and proof of disease claims such as Lupus. Many women have developed immune disorders and silicone toxicity diseases from silicone entiring their bloodstream and into their body from leaking and ruptured breast implants.
Information from womenshealth.gov
Autoimmune diseases such as Lupus are a part of the breast implant class action disease claims.
What is lupus?
Lupus (LOO-puhss) is a chronic, autoimmune (aw-toh-ih-MYOON) disease. It can damage any part of the body (skin, joints, and/or organs inside the body). Chronic means that the signs and symptoms tend to last longer than six weeks and often for many years. In lupus, something goes wrong with your immune system, which is the part of the body that fights off viruses, bacteria, and other germs ("foreign invaders," like the flu). Normally your immune system produces proteins called antibodies that protect the body from these invaders. Autoimmune means your immune system cannot tell the difference between these invaders and your body's healthy tissues ("auto" means "self"). In lupus, your immune system creates autoantibodies (AW-toh-AN-teye-bah-deez), which sometimes attack and destroy healthy tissue. These autoantibodies contribute to inflammation, pain, and damage in various parts of the body.
When people talk about "lupus," they usually mean systemic lupus erythematosus (ur-uh-thee-muh-TOH-suhss), or SLE. This is the most common type of lupus. It is hard to guess how many people in the U.S. have lupus, because the symptoms are so different for every person. Sometimes is not diagnosed. The Lupus Foundation of America thinks that about 16,000 new cases are reported across the country each year.
Although lupus can affect almost any organ system, the disease, for most people, affects only a few parts of the body. For example, one person with lupus may have swollen knees and fever. Another person may be tired all the time or have kidney trouble. Someone else may have rashes. Over time, more symptoms can develop.
Normally, lupus develops slowly, with symptoms that come and go. Women who get lupus most often have symptoms and are diagnosed between the ages of 15 and 45. But the disease also can happen in childhood or later in life.
For some people, lupus is a mild disease. But for others, it may cause severe problems. Even if your lupus symptoms are mild, it is a serious disease that needs constant monitoring and treatment. It can harm your organs and put your life at risk if untreated.
Although the term “lupus” commonly refers to SLE, there are several kinds of lupus:
Systemic lupus erythematosus, or SLE, makes up about 70 percent of all cases of lupus. SLE can be mild or severe and can affect various parts of the body. Common symptoms include fatigue, hair loss, sensitivity to the sun (photosensitivity), painful and swollen joints, unexplained fever, skin rashes, and kidney problems. In general the diagnosis of lupus is based off of a combination of physical symptoms and laboratory results.
Cutaneous (kyoo-TAY-nee-uhss) lupus erythematosus can be limited to the skin or seen in those with SLE. “Cutaneous” means “skin.” Symptoms may include rashes/lesions, hair loss, vasculitis (swelling of the blood vessels), ulcers, and photosensitivity. A doctor will remove a small piece of the rash or sore and look at it under a microscope to tell if someone has skin lupus and what form it is. There are two major kinds of cutaneous lupus:
Discoid (DISS-koid) lupus erythematosus, also called DLE, mainly affects the skin. The discoid rash usually begins as a red raised rash that becomes scaly or changes color to a dark brown. These rashes often appear on the skin on the face and scalp, but other areas may also be affected. Many people with DLE have scarring. Sometimes DLE causes sores in the mouth or nose. A doctor will remove a small piece of the rash or sore and look at it under a microscope to tell if someone has DLE. If you have DLE, there is a small chance that you will later get SLE. Currently there is no way to know if someone with DLE will get SLE.
Subacute cutaneous lupus erythematosus makes up 10 percent of lupus cases. About 50 percent of the time, people with subacute cutaneous lupus also have SLE. Subacute cutaneous lupus causes skin lesions that appear on parts of the body exposed to sun. These lesions do not cause scars.
Lupus can cause these diseases to occur earlier in life:
Heart disease. When you have lupus you are at bigger risk of the main type of heart disease, called coronary artery disease (CAD). This is partly because people with lupus have more CAD risk factors, which may include high blood pressure, high cholesterol, and type 2 diabetes. The inflammation that accompanies lupus also increases the risk of developing CAD. Women with lupus are often less active because of fatigue, joint problems, and/or muscle pain, and this also puts them at risk. Heart disease is the number one killer of all women. But, women with lupus are 50 times more likely to have chest pain or a heart attack than other women of the same age.
Osteoporosis (OSS-tee-oh-puh-ROH-suhss). Women with lupus have more bone loss and broken bones than other women. This might be because some medicines used to treat lupus cause bone loss. The disease itself can also cause bone loss. Also, pain and fatigue can keep women with lupus from exercising. Staying active is important for keeping bones healthy and strong.
Kidney disease. Many symptoms of lupus come from the swelling of organs in the body. Almost half of all people with lupus develop kidney problems, called lupus nephritis. Kidney problems often begin within the first five years after lupus symptoms start to appear. This is one of the more serious complications of lupus, but there are treatments if problems are caught early. However, it is important to know that kidney inflammation is not painful and you can’t feel it. That is why it's important for people with lupus to keep up-to-date with the screenings their doctors recommend. These will include urine and blood tests.
Common signs of lupus are:
- Joint pain and stiffness, with or without swelling
- Muscle aches, pains, or weakness
- Fever with no known cause
- Feeling very tired
- Butterfly-shaped rash across the nose and cheeks
- Other skin rashes
- Unusual weight loss or weight gain
- Anemia (uh-NEE-me-uh) (too few red blood cells)
- Trouble thinking, memory problems, confusion
- Kidney problems with no known cause
- Chest pain when taking a deep breath
- Sun or light sensitivity
- Hair loss
- Purple or pale fingers or toes from cold or stress
Less common symptoms include:
- Blood clots
- Sores in the mouth or nose (usually painless)
- Severe headache
- Dizzy spells
- "Seeing things", not able to judge reality
- Feeling sad
- Dry or irritated eyes
If you hav a registered claim with on of the Silicone breast implant class action facilities and have Lupus contact the Breast Implant helpline to speak to a breast Implant Lawyer and find out if you have a claim.
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 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
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