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, Wa****ngton, 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 do***ents 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 tem****arily 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 do***ents to
the FDA which has never seen the do***ents 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 op****tunity 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 *****s 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 re****t) studies and abstracts have come out
in the U.S. and internationally, all failing to sup****t a causal
relation****p 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 re****ts 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 re****ts 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 re****t 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 Wa****ngton 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 re****t 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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