History of Breast Silicone Implant Litigation: 1977-1999

      The 22-year history of breast implant  June, 1994:  Mayo Clinic epidemiologists published a
litigation provides us with a most important lesson. report in the New England Journal of Medicine which
Specifically, scientific study must preceed commercefinds no increased risk of connective tissue disease in
and marketing.  Even if the scientific data is providedwomen with silicone breast implants.   1995:  The
“after the fact”, it does not stop a legalAmerican College of Rheumatology issued a
disaster from unfolding.  The lack of this data in thestatement that the evidence is “compelling”
1990s led to a 14-year ban on silicone gel implants,that implants do not cause systemic disease.   May,
billions spent in two class action suits, over 20,0001995:  Dow Corning filed for Chapter 11 Bankruptcy,
individual lawsuits, and the temporary collapse of anwith over 20,000 individual lawsuits pending.  Over
entire industry.  The following attempts to410,000 have filed claims in the class action
summarize this story:   1977:  A Houston attorneysettlement.  The bankruptcy essentially halted all
won the first breast implant lawsuit for a Clevelandlitigation.   November, 1995:  A new global
woman who claimed her implants had caused painsettlement was developed without Dow Corning.  
and suffering.  She received a $170,000 settlementDecember, 1995:  More than 20 scientific studies and
from Dow Corning and the case received littleabstracts have been published showing no causal
publicity.   1980s:  Raph Nader’s Public Citizenrelationship between silicone implants and a variety of
Research Group sent out warnings that siliconeauto-immune diseases.   September, 1996:  The
breast implants cause cancer.   1984:  A CaliforniaCalifornia Court of Appeals upheld a decision
attorney won a case for Maria Stern who claimeddismissing Dow Corning from 1,800 lawsuits.  
that her autoimmune disease was caused by herDecember, 1996:  An Oregon Federal Judge ruled
breast implants.  Evidence was introduced from Dowthat plaintiff’s lawyers cannot present evidence
Corning’s own internal documents that they hadthat silicone implants caused disease because it is
been aware of high rupture rates and gel bleed withscientifically invalid.  Seventy claims were dismissed.
the 2nd generation implants.  “Expert  January, 1997:  The American Academy of
witnesses” theorized the silicone–immune linkNeurology reviewed existing studies and reported
for the first time.  The San Francisco court awardedthat there is no link between silicone breast implants
$211,000 in compensatory damages and $1.5 million inand neurological disease.   March, 1997:  A Michigan
punitive damages.    1990:  A television program,Judge ruled that Dow Corning is not liable for
“Face to Face with Connie Chung” aired,hundreds of women in the state.   September, 1997:
discussing the dangers of silicone gel filled breast The Journal of the National Cancer Institute
implants.  Public concern mounted, and apublished a review of scores of medical studies that
Congressional hearing was held on the safety ofconcludes breast implants do not cause breast
breast implants.     July, 1991:  Dow Corningcancer.  The researchers described the evidence for
released 329 studies to the FDA.  In a separatelinking implants to any other disease as "borderline."  
lawsuit against Baxter/Heyer-Schulte, an AlabamaApril, 1998:  Two large scientific studies failed to
court awarded a $5.4 million settlement to Brendashow that silicone implants are linked to neurological
Toole, who showed only preliminary symptoms ofdisease.   December, 1998:  After two years and
systemic autoimmune disease, but had silicone in her$800,000, a panel of four independent experts
lymph nodes.  “Expert witnesses” statedappointed by Judge Sam C. Pointer, overseer of
that she was thus at increased risk of developingimplant lawsuits in the Federal courts, concluded that
autoimmune disease.   December, 1991:  Attorneyscientific evidence so far has failed to show that
Dan Bolton, who won the case for Maria Stern, wonsilicone breast implants cause disease.   June, 1999:
another case for Mariann Hopkins who claimed that The Institute of Medicine released a 400-page
her mixed connective tissue disease was linked toreport prepared by an independent committee of 13
her ruptured silicone breast implants.    February,scientists.  They concluded that although silicone
1992:  A class action lawsuit was filed in Cincinnati bybreast implants may be responsible for localized
Stan Chesley.  The hope was to compensateproblems such as hardening or scarring of breast
women at a faster rate than filing individual lawsuits.tissue, implants do not cause any major diseases
 The FDA Panel recommended that the further usesuch as lupus or rheumatoid arthritis.  The Institute
of silicone implants be limited for reconstruction only.of Medicine is part of the National Academy of
 The panel also concluded that no causal link has yetSciences, the nation's most prestigious scientific
been established between autoimmune disease andorganization.  Congress had asked the Institute to
silicone breast implants.   March, 1992:  Dow Corning,set up the committee.     August, 2004:  August
Bristol-Myers Squibb and Bioplasty all left the breastof 2004 was the deadline for registering for the
implant business.  Dow Corning set up a fund forre-negotiated global settlement with Dow Corning,
further research into the safety of breast implants.  which they established after coming out of chapter
April, 1992:  The FDA placed a ban on the use of13 bankruptcy.  By this time, most all individual
silicone breast implants outside of an FDA-approvedlawsuits against Dow Corning had been thrown out or
research study.  The only women allowed to receivedropped.  The breast implant litigation era ended
implants were those undergoing breastwith little media fanfare.   November, 2006:  The
reconstruction.  All of the implant recipients mustFDA lifted the ban on silicone gel filled implants, 14½
become part of a scientific protocol.   March, 1994:years later.  By now, silicone implants sold are
 A class action lawsuit was finalized by the“4th generation” implants which are much
manufacturers, including Dow Corning, Baxter,improved over the “2nd generation” implants
Bristol-Meyers Squibb/MEC, and 3M.  At $3.4 billion, itwith the thin walls and high “gel bleed” that
was then the largest class action lawsuit in history. led to all the media attention.  The further improved
Women would be allowed to drop out of the“5th generation” implants are still not FDA
settlement if they choose.  Companies could alsoapproved, but are available in other countries.
“opt out” if too few women register claims.