Silicone Breast Implants went on the market in 1962, without any safety testing.
The beginning of the story goes back 60 years.
Some of the earlier important dates were as follows:
- 1895-- The earliest known implant was attempted by Dr. Vincenz Czerny, using a woman's own adipose tissue.
- 1889-- Gersuny tried paraffin injections, with disastrous results.
- 1900s (early to mid)-- a number of other substances were tried, including ivory, glass balls, ground rubber, ox cartilage and Terylene wool, to name a few.
- 1945 and 1950: Berson in 1945 and Maliniac in 1950 performed a flap-based augmentation by rotating the patients chest wall tissue into the breast to add volume.
Scroll through the timeline to witness the events from 1990 onward.
View Text Based Timeline
- 1950’s and 60’s: Silicone injected directly into the breasts becomes popular, first in Japan and later with topless dancers in San Fransico and Las Vegas.
- 1950's-- Silicone injections are banned in Japan because of dangerous side effects, including immunological problems.
- 1950’s-- Polyvinyl sponges began to be implanted into the breasts for breast augmentation. Different types of synthetic sponges were also available, but the initial satisfaction with this type of breast augmentation was very temporary. The breast implants were found to shrink and harden within a year, and the removal of the sponges disfigured some women and was impossible for others. Infections, inflamed tissue, and a link between this type of breast augmentation surgery and cancer began to surface.
- 1954--A Dow Coming Chemical study finds that a chemical in silicone, called silica, has "quite a high order of toxicity," but this study is not released publicly. (1)
- 1956-- Again a Dow Corning Chemical study calls into question the safety of silicone, and again it is concealed from the public. Silicone fluid fed to laboratory dogs is found to migrate throughout their bodies and lodge in vital organs. (2)
- 1960's-- California and Nevada pass laws against silicone injections, classifying them a criminal offence.
- 1961-- As Dow Corning prepares to market the first silicone breast implants the company is advised by its own Center for Aid to Medical Research that silicone will bleed through a silicone bag and be absorbed into human tissue.(3) Silicone leaking from implants can be equivalent to injections of silicone into the body.
- 1960’s-- Soon after the surge of popularity with silicone shots came reports of serious complications. The breast augmentation complications included chronic inflammation, infections that can necessitate mastectomy, organ damage due to silicone migration, and tumor like lumps. Development of silicone granulomas and hardening of the breasts were in some cases so severe that women needed to have mastectomies for treatment. Women sometimes seek medical treatment for complications up to 30 years after receiving this type of injection.
- 1960’s-- The first silicone breast implants are developed by two plastic surgeons from Texas: Frank Gerow and Thomas Cronin.
- 1962-- Alarmed about the health dangers posed by silicone, the FDA issues strict new regulations governing silicone injections.
- 1962-- Timmie Jean Lindsey becomes the first woman to receive silicone breast implants.
- 1963-- Dow Corning begins selling silicone breast implants under the trade name "Silastic" without long-term testing or monitoring of the women who receive them. No mention whatsoever is made of possible health risks, and because the silicone is contained inside a "protective" bag the breast implants are not within the purview of the FDA regulations.
- 1964-- In a letter to the FDA, Dow Corning lawyers represent that liquid silicone, a major component of the silicone-gel implant, is not absorbed by the body. However internal Dow Corning testing had already conclusively demonstrated the exact opposite. (4)
- 1965-- A study finds that lumps develop under the skin when silicone enters human tissue, but Dow Corning continues to insist that silicone is an inert substance. (5)
- 1967-- Dow Corning and three of its top executives are criminally indicted by a federal grandjury in Bay City, Michigan, for permitting deliveries of silicone without FDA approval.
- 1968-- When silicone bags are implanted into dogs the silicone leaks out and is dispersed throughout their systems, according to another secret study for Dow Corning. (6)
- 1970-- Dow Corning reports to the scientific community that implants caused no adverse health consequences in four laboratory dogs. Later, because of the discovery process in court, it will be revealed that one of the dogs died and the other three suffered chronic inflammation. (7)
- 1972-- Dow Corning pharmacologist, Don Bennett, notes in an internal memo that economic considerations are constraining research into the biological applications of silicone. Dr. Bennett later quits in a falling-out with the company over the lack of research.(8)
- 1975-- Numerous plastic surgeons complain to Dow Coming that its newly redesigned silicone implants appear oily and seem to be leaking even before they are surgically inserted. (9) Some surgeons report that the implants appear to have been soaked in Mazola oil. (10) One Dow Corning executive instructs company salesmen to wash and towel-dry the implants before displaying them to surgeons, thus concealing the leakage problem. (11)
- 1975-- Dow Corning employees are compelled to edit a training video for plastic surgeons when implants rupture during the filming of the video.(12)
- 1976-- Thomas Talcott, a senior Dow Corning materials engineer, quits in a dispute over the safety of silicone implants. He will later tell a news reporter, "The manufacturers and surgeons have been performing experimental surgery on humans." (13)
- 1976-- A Dow Coming internal study reveals that the lining of silicone implants loses strength even when sitting on a shelf. (14)
- 1976-- A Dow Corning technical-services specialist, Art Rathjen, complains in a letter to his superiors about the lack of any scientific evidence proving the safety of silicone breasts: "I have proposed again and again that we must begin in-depth study of our gel, envelope, and bleed phenomenon.(15)
- 1976-- The Food and Drug Administration enacts the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act. The 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.
- 1977-- A Dow Corning marketing executive, Chuck Leach, tells a gathering of the International Society of Plastic Surgeons that Dow Coming has a study underway on the possible seepage of silicone from breast implants. Mr. Leach says later he had his fingers "crossed" at the time. (16) In fact, no such study existed.
- 1977-- 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.
- 1978-- Dow Coming represents in a patient brochure that "laboratory studies" prove that implants should "last a lifetime." At the same time, Dow Corning is receiving numerous complaints of spontaneous rupture from surgeons and sales representatives. Another senior Dow Corning engineer writes to his superiors about implanits: "When will we learn at Dow Corning that making a product 'just good enough' almost always leads to products that are 'not quite good enough'?"(17)
- 1980-- The chief of biomaterial safety for Dow Coming, William Boley, tells a private physician it is highly improbable a woman's onset of lupus is connected to her silicone breasts. Mr. Boley claims the implants have been proven safe in "extensive" testing, although three years later he will admit the opposite, saying there is "no valid long-term implant data to substantiate the[irl safety,." (18)
- 1980s-- Ralph Nader's Public Citizen Health Research Group, Washington, D.C. sends out warning signals that silicone breast implants cause cancer.
- 1982 (Jan)-- 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.
- 1984-- Stern vs Dow Corning, San Francisco. Maria Stern's systemic autoimmune disease is found by a jury to be caused by her silicone breast implants. Stern was awarded $211,000 in compensatory damages and $1.5 million in punitive damages. Dow Corning was found fraudulent, having misrepresented animal studies. Case wins on many internal Dow Corning documents that had been discovered in a Dow storage area by attorney Dan Bolton. Bolton introduces the silicone-induced problems for the first time in court, with "experts" that theorize the silicone-immune system connection. The evidence is sealed by a court order.
- 1985-- In an internal report by William Boley and other Dow Corning scientists, the company concludes that the preponderance of available data suggests that silicone can produce immune-mediated diseases. (19) At the same time Dow Corning continues to state publicly there is no evidence that silicone causes disease.
- 1988-- Thousands of women are believed to be experiencing complications with silicone implants, according to the Public Citizen Health Research Group. The complaints include rocklike deformities and chronic inflammation of the breasts, plus more serious diseases such as lupus, systemic sclerosis and neurologic dysfunction. June 1988, 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.
- 1990-- 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.
- 1991 (July)-- 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.
- 1991 (Sept)-- 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.
- 1991 (Sept 18)—John E. Swanson, the guardian of Dow Corning’s much-admired ethics program, tells his employer of 26 years that he can no longer accept its decision to continue selling silicone breast implants and submits his recusal. A recusal means he would have nothing more to do with the product – he would not discuss it or help the company defend itself against criticism. This came after, among other things, Swanson’s wife endured one debilitating illness after another for 17 years – illnesses she believed to be caused by the silicone breast implants manufactured by her husband’s company.
- 1991 (Nov)-- 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.
- 1991 (Dec)-- Hopkins vs Dow Corning, San Francisco. The largest award yet, $7.3 million, is given to Mariann Hopkins whose mixed connective-tissue disease and painful arthritic-like condition 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 had never seen the documents before.
- 1991 (Dec)-- 137 individual lawsuits have been filed against Dow Corning.
- 1992 (Jan)-- 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.
- 1992 (Feb)-- A class action lawsuit is filed in Cincinnati by Stan Chesley. The hope is to compensate women at a faster rate than filing individual lawsuits.
- 1992 (Feb)-- Dow Corning CEO, Lawrence Reed, is replaced by Keith McKennon.
- 1992 (Feb)-- 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.
- 1992 (Feb)-- Many of the Dow Corning internal memos are released to the public.
- 1992 (Mar)-- 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.
- 1992 (Apr)—FDA Commissioner Dr. David 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. Kessler cites a 70-percent rupture rate as one of the problems with implants.
- 1992 (Dec)-- 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."
- 1992 (Dec)-- 3,558 individual lawsuits have been filed against Dow Corning.
- 1993-- For the first time Dow Coming acknowledges that silicone may not be inert, revealing that complaining researchers found a possible link between silicone and immune-systern disease in a study on laboratory rats. The chief medical officer for Dow Corning, Dr. Myron Harrison, is quoted as saying, "It clearly raises my concern that silicone gel might cause immune-system disease." (20 & 21)
- 1993 (June)-- Dick Hazleton becomes CEO of Dow Corning.
- 1993 (Dec)-- By year's end 12,359 individual lawsuits have been filed against Dow Corning.
- 1994 (Mar)-- 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.
- 1994-- Lawsuits are filed against Dow Coming by plastic surgeons who claim the company damaged their medical reputations by misrepresenting the quality of implants.
- 1994 (Mar)-- 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.
- 1994 (Dec)-- 19,092 individual lawsuits have been filed against Dow Corning.
- 1995-- The American College of Rheumatology issues a statement saying the evidence is "compelling" that implants do not cause systemic disease.
- 1995 (Feb)-- Gladys Laas vs Dow Corning.
- 1995-- A judge rules that Dow Corning's parent company, Dow Chemical, can be held liable in lawsuits involving silicone implants. Dow Coming files for bankruptcy protection.
- 1995 (May)-- 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.
- 1995 (June)-- About 440,000 women have registered in the global settlement. About 70,000 can be immediately compensated.
- 1995 (June)-- 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.
- 1995 (Oct)-- 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.
- 1995 (Nov)-- 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.
- 1995 (Dec)-- 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.
- 1995 (Dec)-- 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.
- 1996 (Apr)-- 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.
- 1996 (Sept)-- The California Court of Appeal upholds a decision dismissing Dow Chemical and Dow Corning from 1,800 breast-implant lawsuits.
- 1996 (Dec)-- 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.
- 1997 (Jan)-- 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."
- 1997 (Mar)-- 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.
- 1997 (Aug)-- 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.
- 1997 (Sept)-- 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."
- 1997 (Dec)-- 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.
- 1998 (Apr)-- Two large Scandinavian studies fail to show that silicone implants are linked to neurological disease.
- 1998 (Dec)-- 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.)
- 1998 (Nov)-- 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.
- 1998 (Dec)-- 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.
- 1999 (Jan)-- 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.
- 1999 (spring)-- 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.
- 1999 (June)-- 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.
With info from: www.wikipedia.com www.breast-augmentation-resource.com/html/history.html
www. pbs.org/wgbh/pages/frontline/implants/cron.html
who’s sources were The New York Times, Bloomberg Business News, AP, and American Academy of Neurology
www.siliconeholocaust.org