The #1 concern for most potential breast augmentation patients is whether or not silicone breast implants are safe, can they rupture and if so, what are the major health concerns.
Dr. Michael K. Kim goes into the details of the history of silicone breast implants and their safety.
New Silicone Gel Breast Implants
The New Silicone Gel Breast Implants have three layers of the shell, thereby reducing the likilhood of a rupture. Silicone is a natural substance and so even if it were to rupture, it will not cause breast cancer.
When a silicone breast ruptures, it might go unnoticed because the silicone tends to remain trapped in the surrounding tissue. This is known as a silent rupture.
It's possible, however, for the tissue to become irritated and swollen. Additional scar tissue also might form. This can cause problems in the breast, including:
- Pain, soreness or swelling
- Changes in size or shape
If you have silicone breast implants and suspect that an implant might have ruptured, talk to your Board-certified plastic surgeon. An imaging test, such as an MRI or ultrasound, can show whether the implant has ruptured.
The History of Silicone Breast Implants
1990s: Marks the introduction of fourth-generation breast implants. These devices are designed and manufactured under more stringent criteria with improved quality control for shell thickness and gel cohesiveness. Manufacturers also offer a wider variety of surface textures and implant shapes.
1990 (December): A television program highlighting the 'supposed' dangers of silicone gel breast implants airs on "Face to Face with Connie Chung."
1991 (April): The FDA issues a final ruling calling for submission of PMA applications for silicone gel-filled breast implants.
1991 (July): Dow Corning releases 329 studies to the FDA.
1991 (September The FDA concludes that the silicone breast implant manufacturers' safety data does not prove the devices are safe (but it does not show they are harmful). Manufacturers must submit further data.
1991 (November): The FDA convenes its General and Plastic Surgery Devices Advisory Panel to review all of the safety data in the manufacturers' PMAs. The panel is supposed to advise the FDA on what they can tell the public about the safety and effectiveness of silicone gel-filled breast implants. The panel hearing rejects the data, concluding that the implant manufacturers have failed to provide adequate safety and effectiveness data for their implants. The panel unanimously recommends the devices stay on the market temporarily with limited access. The need for more safety data is stressed.
1992 (January 6): The FDA calls for a voluntary moratorium on the distribution or implantation of silicone gel-filled breast implants, while it reviews new safety and effectiveness information that has been submitted. The manufacturers agree.
1992 (February): The General and Plastic Surgery Devices Panel of the FDA reconvenes to review the new information regarding the safety of silicone gel-filled breast implants. This time the panel recommends that silicone breast implants be removed from the market pending further evaluation of the new data. The panel correctly concludes that no causal link has been established between autoimmune diseases and silicone breast implants, and recommends the limited use of silicone breast implants for reconstruction only.
1992 (February): A class action lawsuit is filed in Cincinnati by attorney Stanley Chesley. The hope is to compensate women at a faster rate than filing individual lawsuits.
1992 (March): Dow Corning decides to stop manufacturing silicone breast implants, as do Bristol-Myers Squibb and Bioplasty. McGhan and Mentor continue to manufacture breast implants. Dow Corning sets up a fund for further research into the safety of breast implants.
1992 (April): The FDA concludes that none of the PMAs submitted for silicone gel breast implants contained sufficient data to support approval. FDA Commissioner lifts the moratorium on silicone breast implants. The only women allowed to receive silicone gel breast implants are those undergoing breast reconstruction, or those who require replacement of existing silicone gel-filled breast implants (revision). Silicone gel breast implants used for these indications are considered to be investigational devices, and women who receive them are followed through the Adjunct Study.
1992 (December): To date 3,558 individual lawsuits have been filed against Dow Corning.
1993 ( December): By the end of 1993 12,359 individual lawsuits have been filed against Dow Corning; that is almost four times the number filed just one year ago.
1994 (March): The class action lawsuit settlement is finalized by the implant manufacturers; it is the largest class action settlement in history. Dow Corning is the largest monetary contributor; the other contributors include Baxter, Bristol-Myers Squibb/MEC, and 3M. There are set monetary amounts that will be awarded to women with specific medical conditions. No requirements are needed to prove breast implants are the cause of the woman’s ailments. Women will be allowed to drop out of the settlement. Manufacturers are allowed to opt out if too few women register claims. The implant manufacturers continue to claim that there is no scientific evidence linking silicone gel breast implants with autoimmune diseases.
1994 (June): The New England Journal of Medicine, publishes an epidemiologic study from the Mayo Clinic which concludes there is no increased risk of connective-tissue disease or other disorders in women with silicone breast implants.
1994 (December): By this date there have been 19,092 individual lawsuits filed against Dow Corning.
1994: Anatomically shaped implants are introduced.
1995: The American College of Rheumatology issues a statement saying the evidence is “compelling” that silicone breast implants did not cause systemic disease in women.
1995 (May): 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.
1995 (June): About 440,000 women have registered in the global settlement; about 70,000 can be immediately compensated.
1995 (June): The Harvard Nurses Epidemiologic Study is published in the New England Journal of Medicine. This study finds there is no increased risk, or signs and symptoms, of connective-tissue disease in women with silicone breast implants.
1995 (November): A new global settlement is devised without Dow Corning. Bristol-Myers Squibb, Baxter and 3M are the participants. The monetary awards are therefore less than the previous settlement.
1995 (December): By this time, 15 individual lawsuits (involving 19 plaintiffs) against Dow Corning have gone to trial. Of these, Dow Corning has won 8 trials, but has lost 6, with one split decision.
1995 (December): By now more than 20 (non-case report) studies and abstracts have been published in the U.S. and internationally. All fail to show that silicone gel breast implants cause a variety of auto-immune related illnesses.
1996 (September): The California Court of Appeals upholds a decision dismissing Dow Chemical and Dow Corning from 1,800 breast-implant lawsuits.
1996 (December): 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.
1997 (January): The American Academy of Neurology reviews existing silicone breast implant studies and reports that “existing research shows no link between silicone breast implants and neurological disorders.”
1997 (March): 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.
1997 (August): The New York Times reports that implant manufacturers have been winning 80% of the cases against them.
1997 (September): The Journal of the National Cancer Institute publishes a review of multiple medical studies that concludes breast implants do not cause breast cancer. The researchers described the scientific evidence for linking implants to any other disease as “borderline.”
1998 (April): Two large Scandinavian studies, which investigated the risk of neurologic disease in women with breast implants, were published in the journal Neurology. The studies failed to show an association between silicone breast implants and neurologic diseases.
1998 (June): The FDA approves Inamed’s investigational device exemption (IDE) study (i.e., Inamed Core Study) of its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
1998 (July): Plaintiffs agree to Dow Corning's offer of $3.2 billion to settle tens of thousands of claims of injury from silicone breast implants. Those who want to cash-out immediately and not file a disease claim will be paid $2,000 within a year. 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. The agreement enables Dow Corning to emerge from bankruptcy proceedings.
1998 (July): After being asked by the British Minister of Health to review the safety of silicone implants, an Independent Review Group (IRG) of scientists report there is no convincing evidence that silicone gel implants cause disease. The U.K., and other countries, have never removed silicone gel-filled breast implants from the market.
1998 (December): After two years and $800,000, a panel of four independent experts appointed by Judge Sam C. Pointer (overseer of all implant lawsuits in the Federal courts) concludes that scientific evidence has failed to show that silicone gel breast implants cause disease.
1999 (June): The Institute of Medicine, set up by the National Academy of Sciences, releases a 400-page report prepared by an independent committee of 13 scientists that confirms the safety of silicone gel breast implants. The report concludes 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.
2000 (May 10): The FDA approves the first PMAs for saline-filled breast implants. These saline breast implants are approved for augmentation in women age 18 years of age and older, and for reconstruction in women of any age.
2000 (August): The FDA approves Mentor's investigational device exemption (IDE) study (i.e., Mentor Core Study) of its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
2000: The National Cancer Institute (NCI) finds no link between breast implants and breast cancer.
2002 (July): The FDA holds an Advisory Panel meeting to update the Panel on post-market data for the two approved saline-filled breast implant PMAs.
2002 (December): Inamed submits a PMA to obtain approval for its silicone gel-filled breast implants.
2003 (October 15): The FDA holds an Advisory Panel meeting to review Allergan’s PMA for its silicone gel-filled breast implants. In a 9 to 6 vote, the panel recommends approvable with certain conditions, including a minimum age requirement for augmentation.
2003 (December): Mentor submits a PMA to obtain approval for its silicone gel-filled breast implants.
2004: The National Cancer Institute finds no link between breast implants and connective tissue disease.
2005 (April): The FDA holds an Advisory Panel meeting to review Inamed’s updated PMA and Mentor’s PMA. In a 5 to 4 vote, the panel does not recommend approval of Inamed's PMA (due to a concern with Style 153 implants in the application). In a 7 to 2 vote, the panel recommends approvable with conditions for Mentor's PMA. The panel recommends that the FDA require certain conditions, which include a minimum age requirement for breast augmentation with silicone gel-filled implants and Post-Approval Studies.
2005: Inamed accepts a higher offer to merge with Allergan, Inc.
2006 (March): Inamed’s merge with Allergan becomes official. Allergan now manufactures the same silicone breast implants once manufactured by Inamed.
2006 (November 17): The FDA approves Allergan’s PMA and Mentor’s PMA for silicone gel-filled breast implants. Allergan’s Natrelle® and Mentor’s Memory Gel® silicone gel-filled implants are now available for breast augmentation (in women at least 22 years old), reconstruction and revision for the first time since the moratorium was established in 1992. As a condition of approval, each manufacturer is required to conduct post-approval studies to further characterize the safety and effectiveness of their silicone gel-filled breast implants and to answer scientific questions that the premarket clinical trials were not designed to answer.
2009: Johnson & Johnson acquires the Mentor Corporation.
2011 (January): The FDA issues a Safety Communication on anaplastic large cell lymphoma (ALCL) in women with breast implants. Based on a review of the scientific literature, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the capsule surrounding the implant.
2011 (June): The FDA issues an “Update on the Safety of Silicone Gel-Filled Breast Implants” that announces a reasonable assurance of safety and effectiveness. It includes preliminary results of the post-approval studies Allergan and Mentor were required to perform as conditions of their silicone gel-filled breast implant 2006 approval.
2012 (March 9): Sientra receives FDA approval for its Silimed®-brand portfolio of round and shaped silicone gel breast implants. Sientra is the US distributor of the Brasilian-manufacturred Silimed implants. For the first time in 20 years, Sientra has successfully broken the existing duopoly in the U.S. breast implant market by becoming the third company to offer saline and silicone gel breast implants.
2013 (February 20): Allergan’s (Natrelle 410®) anatomically shaped highly cohesive silicone gel-filled breast implant is approved by the FDA. The 410 is the most studied highly-cohesive gel implant; it has been used in Europe since 1993 and Canada since 2006.
2013 (June 14): The Mentor Memory Shape® (formerly known as the Contour Profile Gel, CPG) highly cohesive, anatomically shaped silicone gel implant receives FDA approval.