Breast Implant Chronology | Breast Implants On Trial | FRONTLINE
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.
1960s
The first silicone breast implants are developed by two plastic surgeons from Texas: Frank Gerow and Thomas Cronin.
1962
Timmie Jean Lindsey becomes the first woman to receive silicone breast implants.
1976
The Food and Drug Administration enacts theMedical Devices Amendment to the Federal Food,Drug and Cosmetic Act. FDA now has the authority to review and approve the safety andeffectiveness data of new medical devices. Butsince silicone breast implants have been onthe market for almost 15 years, they are "grandfathered." Manufacturers of theimplants, when called to do so by the FDA,will be required to provide safety andeffectiveness data.
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.
1980s
Ralph Nader's Public Citizen Health ResearchGroup, Washington, D.C. sends out warningsignals that silicone breast implants causecancer.
January 1982
FDA proposes to classify silicone breast implants into a Class IIIcategory which would require manufacturers to prove their safety in order to keep them on the market.
1984
Stern vs Dow Corning, San Francisco. Case winson many internal Dow Corning documents thathad been discovered in a Dow storage area byattorney Dan Bolton . Maria Stern's systemicautoimmune disease is found by a jury to becaused by her silicone breast implants. Boltonintroduces the silicone-induced problems forthe first time in court, with "experts" thattheorize the silicone-immune systemconnection. After a monthlong trial, the juryawards Maria Stern $211,000 in compensatorydamages and $1.5 million in punitive damages.The evidence is sealed by a court order.
June 1988
Six years after the 1982 proposal, FDA classifies the implants into Class III. Premarket Approval Applications from silicone breastimplant manufacturers are due by July 1991.The PMA's must prove affirmatively, with validscientific data evaluated by the FDA, thattheir devices are safe and effective. Afterthe PMA's are submitted by the manufacturers,the FDA has 180 days to evaluate the safety data.
December 1990
Program on the dangers of silicone breast implants airs on "Face to Face with Connie Chung."
December 1990
Congressional hearing headed by RepresentativeTed Weiss deals with the safety of siliconebreast implants. This hearing also discussesthe fact that not all the information that the manufacturers have are available for public scrutiny due to a court order from the Stern verdict.
July 1991
Dow Corning releases 329 studies to FDA.
July 1991
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 systemicautoimmune problems, nevertheless had siliconein her lymphatic system according toplaintiffs' witnesses and thus an increasedrisk of developing an autoimmune disease.
September 1991
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.
November 1991
The FDA brings together its General andPlastic Surgery Devices Panel to review all ofthe safety data from the manufacturers' PMA's.The purpose of the panel is to advise FDA asto what they could tell the public about thesafety and effectiveness of the siliconebreast implants based on the PMA's. The panelis composed of a broad range of experts,including representatives from the fields ofplastic surgery, oncology, epidemiology,internal medicine, immunology, radiology,pathology, gynecology, toxicology, sociology,biomaterials and psychology, as well asindustry and consumer groups. The panelhearing rejects the data from Dow Corning,Mentor, McGhan, and Bioplasty, concludingthere is not sufficient data about the risksand benefits of the devices. The panelrecommends the devices stay on the markettemporarily and with limited access. The needfor more safety data is stressed.
December 1991
Hopkins vs Dow Corning, San Francisco. Thelargest award yet, $7.3 million, is given toMariann Hopkins whose mixed connective-tissue disease is linked to her rupturedsilicone breast implants. The lawyer for thecase, Dan Bolton, wins the suit with the help ofinternal memos and studies from the Stern lawsuit,in addition to new studies he recentlyobtained from Dow. Mr. Bolton gives several of the internal documents to the FDA which has never seen the documents before.
December 1991
To date, 137 individual lawsuits have beenfiled against Dow Corning.
January 1992
FDA Commissioner, David Kessler, calls for a voluntary moratorium onthe distribution or implantation of siliconebreast implants until the FDA and the advisorypanel have an opportunity to consider newlyavailable information. The manufacturersagree.
February 1992
The class action lawsuit is filed inCincinnati by Stan Chesley. The hope is tocompensate women at a faster rate than filingindividual lawsuits.
February 1992
Dow Corning CEO, Lawrence Reed, is replaced byKeith McKennon.
February 1992
The General and Plastic Surgery Devices Panelreconvenes to review the new informationregarding the safety of silicone breastimplants. The panel recommends that thefurther use of implants be limited forreconstruction only and that women receivingthe implants participate in scientificprotocols and that epidemiologic studies beconducted to assess the risk of autoimmunedisease. The panel concludes that no causallink has been established between autoimmunedisease and silicone breast implants.
February 1992
Many of the Dow Corning internal memos are released to the public.
March 1992
Dow Corning leaves the silicone breast implantbusiness as do Bristol-Myers Squibb andBioplasty. McGhan and Mentor will stillmanufacture breast implants. Dow sets up afund for further research into the safety ofbreast implants.
April 1992
Dr. Kessler lifts the moratorium on siliconebreast implants. The only women allowed to receive implant surgery are those undergoing breast reconstruction. All of the implant recipients must become part of ascientific protocol.
May 1992
First woman gets implants under new rules.
December 1992
Johnson vs Bristol-Myers Squibb, Houston.Pamela Jean Johnson wins $25 million, $5million actual damages and $20 millionpunitive damages in a case argued by Texasattorney John O'Quinn. A jury finds Ms.Johnson's ruptured silicone implants werelinked to her mixed connective tissue disease,auto-immune responses, chronic fatigue, musclepain, joint pain, headaches, and dizziness.Expert witnesses and lawyers admit hersymptoms amount to "a bad flu."
December 1992
To date 3,558 individual lawsuits have beenfiled against Dow Corning.
June 1993
Dick Hazleton becomes CEO of Dow Corning.
December 1993
By year's end 12,359 individuallawsuits have been filed against Dow Corning.
March 1994
A Houston jury awards three women a total of$27.9 million against 3M, $15 million inpunitive, $12 million in compensatory damagesfor illness. The lawyer arguing the caseagainst 3M is John O'Quinn. The three womensuffered from either atypical lupus,neurological impairment, and a "siliconeinduced" autoimmune problem.
March 1994
The class action suit is finalized by manufacturers with DowCorning being the largest contributor. The othercontributors include Baxter, Bristol-Myers Squibb/MEC, 3M. It is the largest classaction settlement in history. Manufacturersclaim there is no scientific evidence linkingsilicone breast implants with autoimmunediseases. There are set monetary amounts thatwill be awarded to women with specific medicalconditions. No requirements are needed toprove implants are the cause of theirailments. Women will be allowed to drop out ofthe settlement. Companies can also opt out if too few women register claims.
April 1994
Preliminary approval to class action by JudgePointer. Clears the way for women to startapplying for claims in the settlement.
June 1994
The Mayo Clinic epidemiologic study ispublished in the New England Journal of Medicine, which finds no increased risk ofconnective-tissue disease and other disorders that were studied in women withsilicone implants.
September 1994
Final approval of class action/globalsettlement from Judge Pointer.
December 1994
By this date 19,092 individual lawsuits havebeen filed against Dow Corning.
1995
The American College of Rheumatology issues a statement saying the evidence is "compelling" that implants did not cause systemic disease.
February 1995
Gladys Laas vs Dow Corning.
May 1995
Dow Corning files for Chapter 11 bankruptcy.Dow is facing 20,000 lawsuits, some withmultiple plaintiffs and about 410,000potential claims that have been filed in theglobal settlement. The bankruptcy essentiallyhalts all litigation.
June 1995
About 440,000 women have registered in theglobal settlement. About 70,000 can beimmediately compensated.
June 1995
The Harvard Nurses Epidemiologic Study ispublished in the New England Journal of Medicine. This finds no increased risk ofconnective-tissue disease or certain signs and symptomsof connective-tissue disease in women withsilicone implants.
October 1995
Mahlum vs Dow Chemical, Reno. This is thefirst case where Dow Chemical, the parentcompany of Dow Corning, is the sole defendant.Charlotte Mahlum is awarded $3.9 million incompensatory damages and $10 million inpunitive damages. About 13,000 breast implantlawsuits are pending against Dow Chemical.
November 1995
New global settlement is devised minus DowCorning. Bristol-Myers Squibb, Baxter and 3Mare the participants. The monetary awards areless than the previous settlement.
December 1995
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.
December 1995
By now more than 20 (non-case report) studiesand abstracts have come out in the U.S. andinternationally, all failing to support acausal relationship between silicone implantsand a variety of auto-immune relatedillnesses.
April 1996
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.
September 1996
The California Court of Appeal upholds a decision dismissing Dow Chemical and Dow Corning from 1,800 breast-implant lawsuits.
December 1996
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.
January 1997
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."
March 1997
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.
August 1997
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.
September 1997
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."
December 1997
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.
April 1998
Two large Scandinavian studies fail to show that silicone implants are linked to neurological disease.
July 1998
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.)
November 1998
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.
December 1998
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.
January 1999
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.
Spring 1999
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.
June 1999
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)
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