The Rise and Fall of Silicone Breast Implants

The 1940s - 1970s
Year Event

1940s Japanese prostitutes inject their breasts with sponges, paraffin, and non-medical grade silicone to attract American servicemen.

1960s Frank Gerow and Thomas Cronin, two plastic surgeons from Texas, are the first to develop silicone breast implants.

1962 Timmie Jean Lindsey becomes the first woman to receive breast implants.

1976 The Food and Drug Administration (FDA) implements the Medical Devices Act to the Federal Food, Drug and Cosmetic Acts. This allows the FDA to review and approve the safety and effectiveness data of new medical devices. Silicone breast implants are "grandfathered", since they have been on the market fifteen years prior to the enactment of the law. However, when summoned by the FDA, manufacturers of implants must provide safety and effectiveness data.

1977 Richard Mithoff wins the first lawsuit for a Cleveland woman who claims that her ruptured implants and subsequent corrective surgeries caused her pain and suffering. Although she receives a settlement of $170,000 from Dow Corning the case is not highly publicized.

The 1980s
Year Event

1980s Ralph Nader's Public Citizen Health Research Group, Washington D.C., publishes documents which cites breast implants as being carcinogenic.

January 1982 FDA considers classifying breast implants into a Class III category which would mandate that manufacturers prove the safety data of implants in order to sell them.

1984 Stern vs. Dow Corning, San Fransisco. Jury finds that Maris Stern's systemic autoimmune disease is caused by her silicone breast implants. Her attorney Dan Bolton stumbles across internal Dow Corning documents and is the first to argue that systemic autoimmune diseases are silicone-induced. She is awarded $211,000 in compensatory damages and $1.5 million in punitive damages. The judge issues an order for files relating to the Stern case to be kept sealed.

June 1988 FDA categorizes silicone breast implants as Class III. Premarket Approval Applications are due by July 1991 from silicone breast implant manufacturers. The PMA's must prove unequivocally, with scientific data approved by the FDA, that their products are safe and effective. Once the PMA's have been submitted the FDA has 180 days to review data.

1990 - 1991
Year Event

December 1990 Program on the dangers of silicone breast implants airs on "Face to Face with Connie Chung"

December 1990 Representative Ted Weiss heads congressional hearings to investigate the safety of silicone breast implants. The court files from the Stern case are not considered.

July 1991 Dow Corning releases 329 studies to the FDA.

July 1991 Toole vs. Baxter, Alabama. Brenda Toole is awarded $5.4 million dollars from Baxter/Heyer-Shulte. Toole did not have full blown systemic autoimmune disease, but already had silicone present in her lymphatic system, according to her witnesses.

September 1991 FDA finds that silicone breast implant manufacturers did not submit enough information to conclude whether the implants are harmful or safe. Manufacturers are ordered to submit more data.

November 1991 FDA calls upon its General and Plastic Surgery Devices Panel to review all of the safety data from the manufacturer's PMA's. The panel is assembled to advise the FDA on what their stance should be on the safety of silicone breast implants. The panel consists of members which represent diverse academic disciplines. The panel cannot conclude whether the implants are safe and effective and recommends that the devices temporarily stay on the market.

December 1991 Hopkins vs. Corning, San Francisco. Jury finds in Mariann Hopkins favor and decides that she is entitled to $7.3 million. Dan Bolton wins the case by obtaining internal memos from the Stern lawsuit and evidence from new studies obtained from Dow. Mr. Bolton gives several of the damning documents to the FDA which has never seen the items.

December 1991 To date, 137 individual lawsuits have ben filed against Dow Corning.

1992
Year Event

January 1992 FDA commissioner calls for voluntary moratorium on the distribution or implantation of silicone breast implants until a new panel has evaluated new information. The manufacturers agree.

February 1992 Class action lawsuit is filed in Cincinnati by Stan Chesley to compensate plaintiffs faster than individual lawsuits.

February 1992 Dow Corning CEO, Lawrence Reed, is replaced by Keith McKennon.

February 1992 The General and Plastic Surgery Devices Panel reconvenes and after reviewing new information recommends that silicone breast implants be limited to reconstructive procedures. Subjects which elect to have silicone breast implants must enroll in a scientific study to assess whether or not silicone breast implants cause systemic autoimmune diseases. The panel fails to find a link between silicone breast implants and autoimmune disease.

February 1992 Many of the Dow Corning internal memos are released to the public.

March 1992 Dow Corning, Bristol-Myers Squibb and Bioplasty leave the silicone breast implant business. Mentor and McGhan will still manufacture breast implants. Dow establishes a fund to research the safety of brest implants.

April 1992 Dr. Kessler lifts the ban on silicone breast implants. Women who are receiving implants for reconstruction will be allowed access to silicone breast implants. All recipients of silicone breast implants must enroll in the Adjunct Study.

May 1992 First woman gets implants under the new guidelines.

December 1992 Johnson vs. Bristol-Myers Squibb, Houston. Pamela Jean Johnsonis awarded $5 million dollars in actual damages and $20 million dollars in punitive damages. Her attorney John O'Quinn and expert witnesses admit that her symptoms amount to a "bad flu".

December 1992 To date 3,558 individual lawsuits have been filed against Dow Corning.

1993-1995
Year Event

June 1993 Dick Hazleton becomes the 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 concludes that silicone breast implant manufacturer 3M is responsible for the illness of three women. Excellent lawyering by John O'Quinn gets the palintiffs a total of $27.9 million.

March 1994 Class action lawsuit is finalized making it the largest settlement in history. Dow Corning contributes the largest sum. Set monetary amounts will be awarded to women with specific medical conditions. Plaintiffs are not required to produce evidence that implants are the cause of their ailments. Women are allowed the option of dropping out of the settlement. Companies can also back out if too few women issue complaints against them.

April 1994 Class action gets preliminary support from Judge Pointer.

June 1994 Mayo Clinic publishes epidemiological study in the New England Journal of Medicine. The study finds that silicone breast implants do not increase the risk of developing connective-tissue diseases.

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 statement that silicone breast implants are not the culprits of systemic disease.

February 1995 Gladys Laas vs. Dow Corning.

May 1995 Dow Corning files for chapter eleven bankruptcy. At this time Dow is faced with 20,000 lawsuits, some with multiple plaintiffs. Approximately 410,000 potential claims have been filed in the globally. The bankruptcy halts further litigation.

June 1995 Of the 440,000 women that have registered in the global settlement 70,000 are compensated immediately.

June 1995 The Harvard Nurses Epidemiologic Study is published in the New England Journal of Medicine. The study finds no correlation between silicone breast implants and connective tissue disease or certain signs and symptoms of the illness.

October 1995 Mahlum vs. Dow Chemical, Reno. First case in which Dow Chemical, the parent company of Dow Corning is the only defendent. Charlotte Mahlum is subsequently awarded $3.9 million and $10 million in compensatory and punitive damages, respectively. At this time approximately 13,000 lawsuits are pending against Dow Chemical.

November 1995 Dow Corning renigs their contribution to the global settlement, leaving 3M, Bristol-Myers Squibb, and Baxter as the participants. Sum of settlement is much lower than the original amount.

December 1995 To date there have been twenty (non-case report) studies that have failed to implicate silicone breast implants as the cause of autoimmune connective tissue diseases.

1996-1999
Year Event

April 1996 An expert panel is appointed by two New York Federal judges to review the scientific issues involved in silicone breast implants. This action influences judges across the United States.

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, dismisses the cases of 70 complainants, upon the recommendation of a panel he assembled which concluded that the evidence presented by the plaintiff's lawyers is scientifically invalid. Sam C. Pointer, the Alabama judge overseeing all federal implant cases, appoints his own review board of scientists not invloved in the implant litigation.

January 1997 The American Academy of Neurology concludes that "existing research shows no link between silicone breast implants and neurological disorders."

March 1997 A Michigan judge rules that the Dow Chemical Company is a not liable for the medical illnesses reported by women in the state who have undergone silicone breast implant surgery.

August 1997 New York Times reports that implant manufacturers have won 80% of the cases brought against them. Despite this, a state jury finds that Dow Chemical is guilty of deceiving women by concealing safety information about their implants.

September 1997 The Journal of the National Cancer Institute publishes a report which states that silicone breast implants do not cause breast cancer.

December 1997 A Louisiana judge reduces the first class-action suit to its eight original claimants because the claims of 1,800 women are too dissimilar to group into a single lawsuit.

April 1998 Two large Scandinavian studies fail to show that silicone breast implants are linked to neurological disease.

July 1998 Dow Corning offers and plaintiffs agree to a settlment of $3.2 billion. Plaintiffs are assured they will receive any monetary damages within a year. The British minister of health requests that a panel be formed to investigate whether or not silicone breast implants cause disease. The panel finds no substantial evidence linking silicone breast implants with any ailments.

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 cash-out immediately and not file a disease claim will be paid $2,000. This figuire can also be combined wih $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 Nevada Supreme Court upholds a $41 million compensatoiry damage award against Dow Chemical to Charlotte Mahlum claiming that the silicone breast implants are responsible for her multiple-sclerosis-like symptoms. Dow Chemical was found guilty previous to this decision for assisting Dow Corning in withholding evidence about the harmful effects of silicone, however, the court overturns a $10 million punitive award.

January 1999 A jury in 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 United States pending safety studies by manufacturers. They are accessible only to women that are receiving implants for a medical condition or because of complications experienced from existing implants. All women in these circumstances must agree to be part of a scientific investigation to determine the safety and effectiveness of silicone breast implants.

June 1999 The Institute of Medicine, a subsidiary of The National Academy of Sciences, the nation's most prestigious scientific organization, releases an exhaustive report which links silicone breast implants to localized problems such as hardening or scarring of breast tissue. The report does not cite silicone breast implants as the cause of lupus or rheumatoid arthritis.

Reference: FRONTLINE/WGBH Educational Foundation/www.wgbh.org

Back to:

The 1940s - 1970s
*Year*	*Event*
1940s	Japanese prostitutes inject their breasts with sponges, paraffin, and non-medical grade silicone to attract American servicemen.
1960s	Frank Gerow and Thomas Cronin, two plastic surgeons from Texas, are the first to develop silicone breast implants.
1962	Timmie Jean Lindsey becomes the first woman to receive breast implants.
1976	The Food and Drug Administration (FDA) implements the Medical Devices Act to the Federal Food, Drug and Cosmetic Acts. This allows the FDA to review and approve the safety and effectiveness data of new medical devices. Silicone breast implants are "grandfathered", since they have been on the market fifteen years prior to the enactment of the law. However, when summoned by the FDA, manufacturers of implants must provide safety and effectiveness data.
1977	Richard Mithoff wins the first lawsuit for a Cleveland woman who claims that her ruptured implants and subsequent corrective surgeries caused her pain and suffering. Although she receives a settlement of $170,000 from Dow Corning the case is not highly publicized.

The 1980s
*Year*	*Event*
1980s	Ralph Nader's Public Citizen Health Research Group, Washington D.C., publishes documents which cites breast implants as being carcinogenic.
January 1982	FDA considers classifying breast implants into a Class III category which would mandate that manufacturers prove the safety data of implants in order to sell them.
1984	Stern vs. Dow Corning, San Fransisco. Jury finds that Maris Stern's systemic autoimmune disease is caused by her silicone breast implants. Her attorney Dan Bolton stumbles across internal Dow Corning documents and is the first to argue that systemic autoimmune diseases are silicone-induced. She is awarded $211,000 in compensatory damages and $1.5 million in punitive damages. The judge issues an order for files relating to the Stern case to be kept sealed.
June 1988	FDA categorizes silicone breast implants as Class III. Premarket Approval Applications are due by July 1991 from silicone breast implant manufacturers. The PMA's must prove unequivocally, with scientific data approved by the FDA, that their products are safe and effective. Once the PMA's have been submitted the FDA has 180 days to review data.

1990 - 1991
*Year*	*Event*
December 1990	Program on the dangers of silicone breast implants airs on "Face to Face with Connie Chung"
December 1990	Representative Ted Weiss heads congressional hearings to investigate the safety of silicone breast implants. The court files from the Stern case are not considered.
July 1991	Dow Corning releases 329 studies to the FDA.
July 1991	Toole vs. Baxter, Alabama. Brenda Toole is awarded $5.4 million dollars from Baxter/Heyer-Shulte. Toole did not have full blown systemic autoimmune disease, but already had silicone present in her lymphatic system, according to her witnesses.
September 1991	FDA finds that silicone breast implant manufacturers did not submit enough information to conclude whether the implants are harmful or safe. Manufacturers are ordered to submit more data.
November 1991	FDA calls upon its General and Plastic Surgery Devices Panel to review all of the safety data from the manufacturer's PMA's. The panel is assembled to advise the FDA on what their stance should be on the safety of silicone breast implants. The panel consists of members which represent diverse academic disciplines. The panel cannot conclude whether the implants are safe and effective and recommends that the devices temporarily stay on the market.
December 1991	Hopkins vs. Corning, San Francisco. Jury finds in Mariann Hopkins favor and decides that she is entitled to $7.3 million. Dan Bolton wins the case by obtaining internal memos from the Stern lawsuit and evidence from new studies obtained from Dow. Mr. Bolton gives several of the damning documents to the FDA which has never seen the items.
December 1991	To date, 137 individual lawsuits have ben filed against Dow Corning.

1992
*Year*	*Event*
January 1992	FDA commissioner calls for voluntary moratorium on the distribution or implantation of silicone breast implants until a new panel has evaluated new information. The manufacturers agree.
February 1992	Class action lawsuit is filed in Cincinnati by Stan Chesley to compensate plaintiffs faster than individual lawsuits.
February 1992	Dow Corning CEO, Lawrence Reed, is replaced by Keith McKennon.
February 1992	The General and Plastic Surgery Devices Panel reconvenes and after reviewing new information recommends that silicone breast implants be limited to reconstructive procedures. Subjects which elect to have silicone breast implants must enroll in a scientific study to assess whether or not silicone breast implants cause systemic autoimmune diseases. The panel fails to find a link between silicone breast implants and autoimmune disease.
February 1992	Many of the Dow Corning internal memos are released to the public.
March 1992	Dow Corning, Bristol-Myers Squibb and Bioplasty leave the silicone breast implant business. Mentor and McGhan will still manufacture breast implants. Dow establishes a fund to research the safety of brest implants.
April 1992	Dr. Kessler lifts the ban on silicone breast implants. Women who are receiving implants for reconstruction will be allowed access to silicone breast implants. All recipients of silicone breast implants must enroll in the Adjunct Study.
May 1992	First woman gets implants under the new guidelines.
December 1992	Johnson vs. Bristol-Myers Squibb, Houston. Pamela Jean Johnsonis awarded $5 million dollars in actual damages and $20 million dollars in punitive damages. Her attorney John O'Quinn and expert witnesses admit that her symptoms amount to a "bad flu".
December 1992	To date 3,558 individual lawsuits have been filed against Dow Corning.

1993-1995
*Year*	*Event*
June 1993	Dick Hazleton becomes the 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 concludes that silicone breast implant manufacturer 3M is responsible for the illness of three women. Excellent lawyering by John O'Quinn gets the palintiffs a total of $27.9 million.
March 1994	Class action lawsuit is finalized making it the largest settlement in history. Dow Corning contributes the largest sum. Set monetary amounts will be awarded to women with specific medical conditions. Plaintiffs are not required to produce evidence that implants are the cause of their ailments. Women are allowed the option of dropping out of the settlement. Companies can also back out if too few women issue complaints against them.
April 1994	Class action gets preliminary support from Judge Pointer.
June 1994	Mayo Clinic publishes epidemiological study in the New England Journal of Medicine. The study finds that silicone breast implants do not increase the risk of developing connective-tissue diseases.
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 statement that silicone breast implants are not the culprits of systemic disease.
February 1995	Gladys Laas vs. Dow Corning.
May 1995	Dow Corning files for chapter eleven bankruptcy. At this time Dow is faced with 20,000 lawsuits, some with multiple plaintiffs. Approximately 410,000 potential claims have been filed in the globally. The bankruptcy halts further litigation.
June 1995	Of the 440,000 women that have registered in the global settlement 70,000 are compensated immediately.
June 1995	The Harvard Nurses Epidemiologic Study is published in the New England Journal of Medicine. The study finds no correlation between silicone breast implants and connective tissue disease or certain signs and symptoms of the illness.
October 1995	Mahlum vs. Dow Chemical, Reno. First case in which Dow Chemical, the parent company of Dow Corning is the only defendent. Charlotte Mahlum is subsequently awarded $3.9 million and $10 million in compensatory and punitive damages, respectively. At this time approximately 13,000 lawsuits are pending against Dow Chemical.
November 1995	Dow Corning renigs their contribution to the global settlement, leaving 3M, Bristol-Myers Squibb, and Baxter as the participants. Sum of settlement is much lower than the original amount.
December 1995	To date there have been twenty (non-case report) studies that have failed to implicate silicone breast implants as the cause of autoimmune connective tissue diseases.

1996-1999
*Year*	*Event*
April 1996	An expert panel is appointed by two New York Federal judges to review the scientific issues involved in silicone breast implants. This action influences judges across the United States.
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, dismisses the cases of 70 complainants, upon the recommendation of a panel he assembled which concluded that the evidence presented by the plaintiff's lawyers is scientifically invalid. Sam C. Pointer, the Alabama judge overseeing all federal implant cases, appoints his own review board of scientists not invloved in the implant litigation.
January 1997	The American Academy of Neurology concludes that "existing research shows no link between silicone breast implants and neurological disorders."
March 1997	A Michigan judge rules that the Dow Chemical Company is a not liable for the medical illnesses reported by women in the state who have undergone silicone breast implant surgery.
August 1997	New York Times reports that implant manufacturers have won 80% of the cases brought against them. Despite this, a state jury finds that Dow Chemical is guilty of deceiving women by concealing safety information about their implants.
September 1997	The Journal of the National Cancer Institute publishes a report which states that silicone breast implants do not cause breast cancer.
December 1997	A Louisiana judge reduces the first class-action suit to its eight original claimants because the claims of 1,800 women are too dissimilar to group into a single lawsuit.
April 1998	Two large Scandinavian studies fail to show that silicone breast implants are linked to neurological disease.
July 1998	Dow Corning offers and plaintiffs agree to a settlment of $3.2 billion. Plaintiffs are assured they will receive any monetary damages within a year. The British minister of health requests that a panel be formed to investigate whether or not silicone breast implants cause disease. The panel finds no substantial evidence linking silicone breast implants with any ailments.
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 cash-out immediately and not file a disease claim will be paid $2,000. This figuire can also be combined wih $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	Nevada Supreme Court upholds a $41 million compensatoiry damage award against Dow Chemical to Charlotte Mahlum claiming that the silicone breast implants are responsible for her multiple-sclerosis-like symptoms. Dow Chemical was found guilty previous to this decision for assisting Dow Corning in withholding evidence about the harmful effects of silicone, however, the court overturns a $10 million punitive award.
January 1999	A jury in 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 United States pending safety studies by manufacturers. They are accessible only to women that are receiving implants for a medical condition or because of complications experienced from existing implants. All women in these circumstances must agree to be part of a scientific investigation to determine the safety and effectiveness of silicone breast implants.
June 1999	The Institute of Medicine, a subsidiary of The National Academy of Sciences, the nation's most prestigious scientific organization, releases an exhaustive report which links silicone breast implants to localized problems such as hardening or scarring of breast tissue. The report does not cite silicone breast implants as the cause of lupus or rheumatoid arthritis.