Breast Implants Timeline
The History of Breast Implants
Japanese prostitutes have their breasts injected with substances such as paraffin, sponges and non-medical grade silicone to enlarge their breasts, believing that American servicemen favor women with large breasts.
The first silicone breast implants are developed by two plastic surgeons from Texas: Frank Gerow and Thomas Cronin.
Timmie Jean Lindsey becomes the first woman to receive silicone breast implants.
The Food and Drug Administration enacts the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act. FDA now has the authority to review and approve the safety and effectiveness data of new medical devices. But since silicone breast implants have been on the market for almost 15 years, they are "grandfathered." Manufacturers of the implants, when called to do so by the FDA, will be required to provide safety and effectiveness data.
Richard Mithoff, a Houston attorney, wins the first lawsuit for a Cleveland woman who claims that her ruptured implants and subsequent operations had caused pain and suffering. She receives a $170,000 settlement from Dow Corning. Case receives little publicity.
Ralph Nader's Public Citizen Health Research Group, Washington, D.C. sends out warning signals that silicone breast implants cause cancer.
FDA proposes to classify silicone breast implants into a Class III category which would require manufacturers to prove their safety in order to keep them on the market.
Stern vs Dow Corning, San Francisco. Case wins on many internal Dow Corning documents that had been discovered in a Dow storage area by attorney Dan Bolton . Maria Stern's systemic autoimmune disease is found by a jury to be caused by her silicone breast implants. Bolton introduces the silicone-induced problems for the first time in court, with "experts" that theorize the silicone-immune system connection. After a monthlong trial, the jury awards Maria Stern $211,000 in compensatory damages and $1.5 million in punitive damages. The evidence is sealed by a court order.
Six years after the 1982 proposal, FDA classifies the implants into Class III. Premarket Approval Applications from silicone breast implant manufacturers are due by July 1991. The PMA's must prove affirmatively, with valid scientific data evaluated by the FDA, that their devices are safe and effective. After the PMA's are submitted by the manufacturers, the FDA has 180 days to evaluate the safety data.
Program on the dangers of silicone breast implants airs on "Face to Face with Connie Chung."
Congressional hearing headed by Representative Ted Weiss deals with the safety of silicone breast implants. This hearing also discusses the fact that not all the information that the manufacturers have are available for public scrutiny due to a court order from the Stern verdict.
Dow Corning releases 329 studies to FDA.
Toole vs Baxter, Alabama. Jury decides against Baxter/Heyer-Shulte and awards the largest settlement so far, $5.4 million, to Brenda Toole. Toole, who shows only preliminary symptoms of systemic autoimmune problems, nevertheless had silicone in her lymphatic system according to plaintiffs' witnesses and thus an increased risk of developing an autoimmune disease.
FDA concludes that the silicone breast implant manufacturers' safety data does not prove the devices are safe--or harmful. Manufacturers are told to submit further data.
The FDA brings together its General and Plastic Surgery Devices Panel to review all of the safety data from the manufacturers' PMA's. The purpose of the panel is to advise FDA as to what they could tell the public about the safety and effectiveness of the silicone breast implants based on the PMA's. The panel is composed of a broad range of experts, including representatives from the fields of plastic surgery, oncology, epidemiology, internal medicine, immunology, radiology, pathology, gynecology, toxicology, sociology, biomaterials and psychology, as well as industry and consumer groups. The panel hearing rejects the data from Dow Corning, Mentor, McGhan, and Bioplasty, concluding there is not sufficient data about the risks and benefits of the devices. The panel recommends the devices stay on the market temporarily and with limited access. The need for more safety data is stressed.
Hopkins vs Dow Corning, San Francisco. The largest award yet, $7.3 million, is given to Mariann Hopkins whose mixed connective- tissue disease is linked to her ruptured silicone breast implants. The lawyer for the case, Dan Bolton, wins the suit with the help of internal memos and studies from the Stern lawsuit, in addition to new studies he recently obtained from Dow. Mr. Bolton gives several of the internal documents to the FDA which has never seen the documents before.
To date, 137 individual lawsuits have been filed against Dow Corning.
FDA Commissioner, 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. The manufacturers agree.
The class action lawsuit is filed in Cincinnati by Stan Chesley. The hope is to compensate women at a faster rate than filing individual lawsuits.
Dow Corning CEO, Lawrence Reed, is replaced by Keith McKennon.
The General and Plastic Surgery Devices Panel reconvenes to review the new information regarding the safety of silicone breast implants. The panel recommends that the further use of implants be limited for reconstruction only and that women receiving the implants participate in scientific protocols and that epidemiologic studies be conducted to assess the risk of autoimmune disease. The panel concludes that no causal link has been established between autoimmune disease and silicone breast implants.
Many of the Dow Corning internal memos are released to the public.
Dow Corning leaves the silicone breast implant business as do Bristol-Myers Squibb and Bioplasty. McGhan and Mentor will still manufacture breast implants. Dow sets up a fund for further research into the safety of breast implants.
Dr. Kessler lifts the moratorium on silicone breast implants. The only women allowed to receive implant surgery are those undergoing breast reconstruction. All of the implant recipients must become part of a scientific protocol.
First woman gets implants under new rules.
Johnson vs Bristol-Myers Squibb, Houston. Pamela Jean Johnson wins $25 million, $5 million actual damages and $20 million punitive damages in a case argued by Texas attorney John O'Quinn. A jury finds Ms. Johnson's ruptured silicone implants were linked to her mixed connective tissue disease, auto-immune responses, chronic fatigue, muscle pain, joint pain, headaches, and dizziness. Expert witnesses and lawyers admit her symptoms amount to "a bad flu."
To date 3,558 individual lawsuits have been filed against Dow Corning.
Dick Hazleton becomes CEO of Dow Corning.
By year's end 12,359 individual lawsuits have been filed against Dow Corning.
A Houston jury awards three women a total of $27.9 million against 3M, $15 million in punitive, $12 million in compensatory damages for illness. The lawyer arguing the case against 3M is John O'Quinn. The three women suffered from either atypical lupus, neurological impairment, and a "silicone induced" autoimmune problem.
The class action suit is finalized by manufacturers with Dow Corning being the largest contributor. The other contributors include Baxter, Bristol-Myers Squibb/MEC, 3M. It is the largest class action settlement in history. Manufacturers claim there is no scientific evidence linking silicone breast implants with autoimmune diseases. There are set monetary amounts that will be awarded to women with specific medical conditions. No requirements are needed to prove implants are the cause of their ailments. Women will be allowed to drop out of the settlement. Companies can also opt out if too few women register claims.
Preliminary approval to class action by Judge Pointer. Clears the way for women to start applying for claims in the settlement.
The Mayo Clinic epidemiologic study is published in the New England Journal of Medicine, which finds no increased risk of connective-tissue disease and other disorders that were studied in women with silicone implants.
Final approval of class action/global settlement from Judge Pointer.
By this date 19,092 individual lawsuits have been filed against Dow Corning.
The American College of Rheumatology issues a statement saying the evidence is "compelling" that implants did not cause systemic disease.
Gladys Laas vs Dow Corning.
Dow Corning files for Chapter 11 bankruptcy. Dow is facing 20,000 lawsuits, some with multiple plaintiffs and about 410,000 potential claims that have been filed in the global settlement. The bankruptcy essentially halts all litigation.
About 440,000 women have registered in the global settlement. About 70,000 can be immediately compensated.
The Harvard Nurses Epidemiologic Study is published in the New England Journal of Medicine. This finds no increased risk of connective-tissue disease or certain signs and symptoms of connective-tissue disease in women with silicone implants.
Mahlum vs Dow Chemical, Reno. This is the first case where Dow Chemical, the parent company of Dow Corning, is the sole defendant. Charlotte Mahlum is awarded $3.9 million in compensatory damages and $10 million in punitive damages. About 13,000 breast implant lawsuits are pending against Dow Chemical.
New global settlement is devised minus Dow Corning. Bristol-Myers Squibb, Baxter and 3M are the participants. The monetary awards are less than the previous settlement.
By now 15 individual lawsuits against Dow Corning have gone to trial involving some 19 plaintiffs. Of these, Dow Corning have had 8 trial "wins" and 6 trial "losses," with one split decision.
By now more than 20 (non-case report) studies and abstracts have come out in the U.S. and internationally, all failing to support a causal relationship between silicone implants and a variety of auto-immune related illnesses.
Two Federal judges in New York appoint an impartial, expert panel to review the scientific issues involved in breast implant lawsuits. This rare move will influence judges throughout the country.
The California Court of Appeal upholds a decision dismissing Dow Chemical and Dow Corning from 1,800 breast-implant lawsuits.
Oregon Federal Judge Robert E. Jones, after input from a panel of impartial scientists, rules that plaintiffs' lawyers cannot present evidence that silicone implants caused disease because it is scientifically invalid. He dismisses 70 claims, shocking the litigation community.
Sam C. Pointer, the Alabama judge overseeing all federal implant cases, appoints his own panel of scientific experts who are not connected to implant litigation.
The American Academy of Neurology reviews existing silicone implant studies and reports that "existing research shows no link between silicone breast implants and neurological disorders."
A judge in Michigan rules that the Dow Chemical Company is not liable for the medical problems of hundreds of women in the state. Thus far, some state appellate courts have upheld Dow Chemical's liability and others have not.
The New York Times reports that implant manufacturers have been winning 80% of cases against them. Nevertheless, a state jury in the first class-action suit finds that Dow Chemical (which owns half of Dow Corning) knowingly deceived women by hiding safety information about the silicone in their implants.
The Journal of the National Cancer Institute publishes a review of scores of medical studies that concludes breast implants do not cause breast cancer. The researchers described the evidence for linking implants to any other disease as "borderline."
The first class-action lawsuit in an implant case is reduced to its original eight claimants when a Louisiana judge decides the 1,800 women have cases too dissimilar to group into one lawsuit.
Two large Scandinavian studies fail to show that silicone implants are linked to neurological disease.
Plaintiffs agree to Dow Corning's offer of $3.2 billion to settle tens of thousands of claims of injury from silicone breast implants. The agreement will let the plaintiffs receive money within a year and also enable Dow Corning to emerge from bankruptcy proceedings.
After being asked by the British minister of health to review the safety of silicone implants, a seven-member panel of scientists report no convincing evidence that they cause disease. (The U.K. has never removed silicone implants from the market.)
Dow Corning files for bankruptcy reorganization, which includes the $3.2 billion previously agreed-to settlement and offers claimants several payout options. Those who want to cash-out immediately and not file a disease claim will be paid $2,000. This figure can also be combined with $5,000 for implant removal surgery and $20,000 for a ruptured implant. Those who have already filed a disease claim will receive between $10,000 and $250,000 plus any compensation claimed for removal or ruptures.
After two years and $800,000, a panel of four independent experts appointed by Judge Sam C. Pointer, overseer of implant lawsuits in the Federal courts, concludes that scientific evidence so far has failed to show that silicone breast implants cause disease.
Nevada Supreme Court upholds a compensatory damage award of $41 million against Dow Chemical to Charlotte Mahlum for her multiple-sclerosis-like symptoms. Dow Chemical was earlier found liable for helping Dow Corning conceal evidence about the harmful effects of silicone. The court, however, overturns a $10 million punitive award.
A jury in a Washington Federal court awards $10 million in compensatory damages against Bristol-Myers Squibb Co. to an attorney who claimed her implants caused scleroderma.
Silicone-gel-filled implants remain off the market in the U.S. pending manufacturer safety studies. They are available only to women who have had or will have breast surgery for a medical condition or have other complications from existing implants, and only if they agree to be part of a scientific protocol, or study. The latest status of silicone breast implants can be found at the FDA website.
The Institute of Medicine releases a 400-page report prepared by an independent committee of 13 scientists. They conclude that although silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants do not cause any major diseases such as lupus or rheumatoid arthritis. The Institute of Medicine is part of the National Academy of Sciences, the nation's most prestigious scientific organization. Congress had asked the Institute to set up the committee. The committee did not conduct any original research; they examined past research and other materials, and conducted public hearings to hear all sides of the issue.
(Sources: The New York Times, Bloomberg Business News, AP, and American Academy of Neurology)