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1940s
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 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.
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 Research Group,
Washington, D.C. sends out warning signals that silicone breast
implants cause cancer.
January 1982
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. 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.
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.
December 1990
Program on the dangers of silicone breast implants airs on "Face to
Face with Connie Chung."
December 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.
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
systemic autoimmune problems, nevertheless had silicone in her
lymphatic system according to plaintiffs' witnesses and thus an
increased risk 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 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.
December 1991
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.
December 1991
To date, 137 individual lawsuits have been filed against Dow Corning.
January 1992
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.
February 1992
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.
February 1992
Dow Corning CEO, Lawrence Reed, is replaced by Keith McKennon.
February 1992
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.
February 1992
Many of the Dow Corning internal memos are released to the public.
March 1992
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.
April 1992
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.
May 1992
First woman gets implants under new rules.
December
1992
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."
December 1992
To date 3,558 individual lawsuits have been filed against Dow Corning.
June 1993
Dick Hazleton becomes CEO of Dow Corning.
December 1993
By year's end 12,359 individual lawsuits have been filed against Dow
Corning.
March 1994
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.
March 1994
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.
April 1994
Preliminary approval to class action by Judge
Pointer. Clears the way for women to start applying for claims in the
settlement.
June 1994
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.
September
1994
Final approval of class action/global settlement from Judge Pointer.
December 1994
By this date 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 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 with multiple plaintiffs and about 410,000
potential claims that have been filed in the global settlement. The
bankruptcy essentially halts all litigation.
June 1995
About 440,000 women have registered in the global settlement. About
70,000 can be immediately compensated.
June 1995
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.
October 1995
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.
November 1995
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.
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) 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.
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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