Here is a brief summary of the history of breast implants in the United States. For a more detailed presentation of this material, including some details on the lawsuits filed against the implant manufacturers:
1895: Dr. Vincenz Czerny performs a breast reconstruction by removing a large lipoma from his side and transplanting it into the breast defect.
Before 1900: There are breast enlargement case reports using paraffin wax injections and glass balls, but no specific documentation exists exactly when it is first performed. The use of paraffin to improve and rebuild the breasts was interrupted in the 1920s because of the inflammatory reactions, “paraffinomas”, and the hardening of the breast that was occurring.
1920-40: Lipid transplants from the abdomen, buttocks, fat injections and tissue flap rotations were performed with breast augmentation and reconstruction. The resorption of fat was a common problem.
1940s: Japanese prostitutes use non-medical grade silicone injections to increase their breasts. The procedure becomes popular and extends to the United States. Injection of liquid silicone causes frequent and significant complications, including chronic inflammation, granulation, fistulas, recurrent infections, and hardening of the breast.
1950s: Polyvinyl alcohol sponges [Ivalon sponge] were used as breast implants
1950s to 1960s: Injections of hydrocarbons, petroleum jelly, silicones and vegetable oils were used but suffered from infections, granulomas, fistulas and firmness of the breasts.
1962: Two plastic surgeons from Texas, Thomas Cronin and Frank Gerow, perform the first breast augmentation on Timmie Jean Lindsey using a breast implant filled with silicone gel.1963: This marks the beginning of first generation silicone gel breast implants ; Dow Corning manufactures breast implants filled with Cronin-Gerow silicone gel. These first generation implants were built using a shell, two pieces, relatively thick, sewn. The hull was filled with a moderately viscous silicone gel. The implant was anatomically shaped and had several Dacron patches on the posterior surface to help prevent rotation.
1964: Arion Laboratories in France manufactures the first saline implant; these could be placed through a smaller incision than was needed for silicone gel implants.
1968: Heyer Schulte Corporation becomes the first national manufacturer of breast implants filled with saline.
1969: The Mentor Corporation is founded in Minneapolis, Minnesota, with an initial focus on urology.
1970s: Second generation silicone gel-filled breast implants entered the market in the 1970s. These devices had thinner, seamless, round-shaped shells, and were filled with a less viscous silicone gel . History shows that these implant shells tend to break more easily.
70’s: The polyurethane foam cover for implants is becoming popular for preventing capsular contracture. Moss begins to disintegrate in the body almost immediately, making removal difficult and sometimes causing other complications.
1974: The McGhan Medical Corporation is founded by Don McGhan who first worked in the laboratory for Dow Corning in 1963 when the first silicone gel breast implants were manufactured. McGhan Medical Corporation manufactured and sold breast implants filled with silicone gel.
1976: Congress adopts medical device amendments to the Federal Food, Drugs and Cosmetics Act. The FDA now has the power to review and approve new medical devices based on their safety and effectiveness. Since breast implants filled with silicone gel have been on the market for almost 15 years, their continued use is “protected”. Silicone gel implants remain available for all women for breast augmentation, but implant manufacturers will be required to provide safety and effectiveness. data to the FDA.
1977: Minnesota Mining and Manufacturing Company (3M) acquires McGhan Medical and controls the production of the Silicone Gel Breast Implant product line.Years 1980: Third generation silicone gel-filled breast implants enter the market. Manufacturers continue to focus on improving the strength and integrity of the hull. McGhan Corporation and Mentor Corporation both develop a multilayer shell to strengthen the hull and reduce bleeding of silicone gel from intact implants.
1980s: The Public Health Research Group of Ralph Nader’s Citizens in Washington, DC sends warning signals that breast implants filled with silicone gel cause cancer.
1982 (January): The FDA proposes to reclassify silicone breast implants into a category that would require manufacturers to prove their safety in order to keep them on the market.
1984: A new McGhan medical company is created to buy back the assets held by 3M. McGhan Medical continues to manufacture breast implants.
1984: The Mentor Corporation acquires Heyer-Schulte, a manufacturer of breast implants.
1986: After being acquired by First America Corporation, McGhan Medical changed its name to Inamed, a name intended to convey the concepts of “innovation” and “medicine”.
1988 (June): As a result of new safety concerns, the FDA reclassifies silicone gel breast implants into Cass III devices. This means that manufacturers will have to submit pre-market approval (PMA) applications and prove that the implants are safe. LDCs must prove, with sound scientific evidence, that silicone implants are safe and effective in order to keep them on the market.
Late 1980s: Textured surface implants are introduced.
1990s: marks the introduction of fourth-generation breast implants. These devices are designed and manufactured according to stricter criteria with improved quality control for shell thickness and gel cohesion. Manufacturers also offer a greater variety of surface textures and implant shapes.
1990 (December): A television program highlighting the “supposed” dangers of silicone gel breast implants is broadcast face-to-face with Connie Chung.
1991 (April): The FDA makes a final decision calling for the submission of MA applications for breast implants filled with silicone gel.
1991 (July): Dow Corning publishes 329 studies at the FDA.
1991 (September): The FDA concludes that the safety data from silicone breast implant manufacturers does not prove that the devices are safe (but this does not prove that they are harmful). Manufacturers must submit additional data.1992 (January 6): FDA calls for a voluntary moratorium on the distribution or implantation of breast implants filled with silicone gel, while reviewing new safety information and effectiveness that have been submitted. Manufacturers agree.
1992 (February): The FDA General Surgery and Plastics Group meets again to review new information regarding the safety of breast implants filled with silicone gel. This time, the committee recommends that silicone breast implants be removed from the market pending further evaluation of the new data. The group 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 pace than filing individual lawsuits.
1992 (March): Dow Corning decides to stop the manufacture of silicone breast implants, just like Bristol-Myers Squibb and Bioplasty. McGhan and Mentor continue to make breast implants. Dow Corning establishes fund to continue research on breast implant safety.
1992 (April): The FDA concludes that none of the LDCs submitted for silicone gel breast implants contained sufficient data to support approval. FDA Commissioner lifts moratorium on silicone breast implants. The only women allowed to receive silicone gel breast implants are those undergoing breast reconstruction, or those requiring replacement of existing silicone gel-filled breast implants (revision). The silicone gel breast implants used for these indications are considered as experimental devices, and the women who receive them are followed as part of the complementary study.
1992 (December): To date, 3,558 individual actions have been filed against Dow Corning. 1993 (December): at the end of 1993, 12,359 individual actions were filed against Dow Corning; That’s almost four times the number filed a year ago.
1994 (March): The settlement of the class action is finalized by the implant manufacturers; It is the largest collective action settlement in history. Dow Corning is the largest monetary contributor; other contributors include Baxter, Bristol-Myers Squibb / MEC and 3M. There are monetary amounts that will be awarded to women with specific medical conditions. No requirement is needed to prove that breast implants are the cause of the woman’s ailments. Women will be allowed to leave the institution. Manufacturers are allowed to opt out if too few women register claims. Implant manufacturers continue to claim that there is no scientific evidence linking silicone gel breast implants to autoimmune diseases.
1994 (June): The New England Journal of Medicine publishes an epidemiological study of the Mayo Clinic that concludes that there is no increased risk of connective tissue disease or other disorders in women with breast implants. silicone.
1994 (December): At that date, 19,092 individual actions were commenced against Dow Corning.
1994: Anatomically shaped implants are introduced.
1995: The American College of Rheumatology issues a statement that the evidence is “convincing” that silicone breast implants do not cause systemic disease in women.
1995 (May): Dow Corning files Chapter 11 bankruptcy application. Dow faces 20,000 lawsuits, some with several plaintiffs and approximately 410,000 potential claims that were filed in the Comprehensive Settlement. Bankruptcy essentially interrupts any dispute.
1995 (June): Approximately 440,000 women enrolled in the comprehensive settlement; about 70,000 can be immediately compensated.
1995 (June): The epidemiological study of Harvard nurses is published in the New England Journal of Medicine. This study concludes that there is no increased risk, or signs and symptoms, of connective tissue disease in women with silicone breast implants.
1995 (November): A new comprehensive settlement is designed without Dow Corning. Bristol-Myers Squibb, Baxter and 3M are the participants. The monetary rewards are therefore lower than the previous regulation.
1995 (December): To date, 15 individual lawsuits (involving 19 plaintiffs) against Dow Corning have been tried. Of these, Dow Corning won 8 trials, but lost 6, with a split decision.1995 (December): To date, more than 20 studies and abstracts have been published in the US and around the world . Not all of them show that silicone gel breast implants cause a variety of autoimmune diseases.
1996 (September): The California Court of Appeals upholds the decision to fire Dow Chemical and Dow Corning of 1,800 lawsuits against breast implants.
1996 (December): Oregon Federal Judge Robert E. Jones, after receiving the opinion of a panel of impartial scientists, states that plaintiffs’ lawyers can not prove that silicone implants cause illness because that they are scientifically invalid. He rejects 70 requests, which offends the litigation community.
1997 (January): The American Academy of Neurology reviews existing studies on silicone breast implants and reports that “existing research shows no link between silicone breast implants and neurological disorders.”
1997 (March): A Michigan judge states that the Dow Chemical Company is not responsible for the medical problems of hundreds of women in the state. So far, some appellate jurisdictions have confirmed Dow Chemical’s responsibility and others do not.
1997 (August): The New York Times reports that implant manufacturers have won 80% of cases against them.
1997 (September): The Journal of the National Cancer Institute publishes a review of several medical studies that concludes that breast implants do not cause breast cancer. The researchers described the scientific evidence to link implants to any other disease as “borderline”.
1998 (April): Two large Scandinavian studies, which studied the risk of neurological disease in women with breast implants, were published in the journal Neurology. Studies have failed to show an association between silicone breast implants and neurological diseases.
1998 (June): FDA approves Inamed’s study of silicone gel-filled breast implants for a limited number of augmentation, reconstruction and revision patients at a limited number of sites.
1998 (July): Complainants accept Dow Corning’s $ 3.2 billion bid for tens of thousands of Silicone Breast Implant Injury claims. Those who want to cash in immediately and do not file a claim against the disease will receive $ 2,000 in the year. This figure can also be combined with $ 5,000 for implant resection surgery and $ 20,000 for a broken implant. Those who have already filed a claim against the disease will receive between $ 10,000 and $ 250,000 plus any compensation claimed for removal or breakages. The agreement allows Dow Corning to go out of bankruptcy proceedings.1998 (July): Plaintiffs accept Dow Corning’s $ 3.2 billion bid to settle tens of thousands of breast implant-related injury claims silicone. Those who want to cash in immediately and do not file a claim against the disease will receive $ 2,000 in the year. This figure can also be combined with $ 5,000 for implant resection surgery and $ 20,000 for a broken implant. Those who have already filed a claim against the disease will receive between $ 10,000 and $ 250,000 plus any compensation claimed for removal or breakages. The agreement allows Dow Corning to go out of bankruptcy proceedings.
1998 (July): After being invited by the UK Minister of Health to review the safety of silicone implants, a group of independent scientists (IRG) reports that there is no convincing evidence that silicone gel implants cause the disease. The UK and other countries have never removed breast implants filled with silicone gel from the market.
1998 (December): After two years and $ 800,000, a panel of four independent experts appointed by Judge Sam C. Pointer (supervisor of all federal court implant trials) concludes that the scientific evidence has not demonstrated that silicone gel breast implants cause disease. .
1999 (June): The Institute of Medicine, created by the National Academy of Sciences, publishes 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 even though silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants do not cause major diseases such as lupus or rheumatoid arthritis.
2000 (May 10): The FDA approves the first LDCs for breast implants filled with saline. These saline breast implants are approved for augmentation in women aged 18 and over, and for reconstruction in women of all ages.
2000 (August): The FDA approves the Mentor study on silicone gel-filled breast implants (FDI) 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 group meeting to update the post-marketing data panel for the two LDCs for approved saline-filled breast implants.
2002 (December): Inamed submits PMA for approval of breast implants filled with silicone gel.
2003 (October 15): FDA holds Advisory Committee meeting to review Allergan AGP for its silicone gel-filled breast implants. In a vote of 9 to 6, the committee recommends approval with certain conditions, including a minimum age requirement for the increase.
2003 (December): Mentor submits PMA for approval of breast implants filled with silicone gel.
2004: The National Cancer Institute finds no link between breast implants and connective tissue disease.
2005 (April): The FDA holds an Advisory Group meeting to review Inamed’s updated PMA and Mentor’s PMA. In a vote of 5 to 4, the committee does not recommend approval of the Inamed PMA (due to a concern regarding Style 153 implants in the application). In a 7 to 2 vote, the committee recommends conditional approval for Mentor’s PMA. The committee recommends that the FDA require certain conditions, including a minimum age for breast augmentation with implants filled with silicone gel and post-approval studies.
2005: Inamed accepts higher merger offer with Allergan, Inc.
2006 (March): The merger of Inamed with Allergan becomes official. Allergan now manufactures the same silicone breast implants that were once made by Inamed.
2006 (November 17): FDA approves Allergan PMA and Mentor PMA for silicone gel-filled breast implants. Allergan’s Natrelle® Silicone Gel and Mentor’s Memory Gel® Implants are now available for breast augmentation (for women ages 22 and up), reconstruction and revision for the first time since birth. moratorium in 1992. As a condition of approval, each manufacturer is required to conduct post-approval studies to further characterize the safety and efficacy of their silicone gel-filled breast implants and to respond to scientific questions to which the tests are based. Pre-marketing clinics have not been designed to respond.
2009: Johnson & Johnson acquires the Mentor Corporation.2011 (January): The FDA publishes a safety communication on Anaplastic Large Cell Lymphoma (ACGM) 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): FDA publishes “Silicone-Filled Breast Implant Safety Update” announcing reasonable assurance of safety and effectiveness. It includes the preliminary results of the post-approval studies that Allergan and Mentor had to perform as conditions for their approval of the Silicone Filled Breast Implant in 2006.
2012 (March 9): Sientra receives FDA approval for its Silimed® Silicone Gland Breast Implants portfolio in round and shaped form. Sientra is the US distributor of Silimed implants made in Brazil. For the first time in 20 years, Sientra has successfully broken the existing duopoly in the US breast implant market by becoming the third company to offer breast implants in silicone gel and saline.
2013 (Feb. 20): Allergan Anatomically Cohesive Silicone-Filled Breast Implant (Natrelle 410®) is approved by the FDA. 410 is the most highly cohesive gel implant studied; it has been used in Europe since 1993 and in Canada since 2006.
2013 (June 14): Mentor Memory Shape® Silicone Gel (formerly known as Gel Contour Profile, CPG), highly cohesive and anatomically shaped, is approved by the FDA.
Breast Implant Illness; Bia-Alcl, IUD’s…FDA & Class III Medical Devices