Breast Implant Timeline
1890: Written descriptions of breast augmentations with paraffin wax injections and the use of glass balls, but it is not known when this was first performed.
1895: Austrian-German surgeon, Victor Czerny, harvests a benign fatty tumor from a woman’s back to reconstruct a breast defect following removal of a breast tumor.
1920s: The use of paraffin wax to enhance and reconstruct breasts is discontinued due to complications such as “paraffinomas” and “wax cancer”; the breast became hard and significant inflammatory reactions occurred.
1940s: Japanese prostitutes use non-medical grade silicone injections (probably silicone oil lubricants from WWII) to augment their breasts believing that American servicemen favor women with large breasts. The procedure becomes popular and spreads to the USA. The injection of liquid silicone resulted in frequent and significant complications, including chronic inflammation, granulation formation, recurrent infections, and hardening of the breast.
1945: Morton Berson performed a rotational flap using chest tissue to increase breast volume
1950s: Polyvinyl alcohol sponges [Ivalon sponge] (contained within a polyethylene bag) were used as breast implants. Other sponges used were polyether, silastic, and Teflon.
1950 – early 1960’s: Injections of hydrocarbons, petroleum jelly, silicone oils, vegetable oils and bees wax were used for breast augmentation. These substances produced inflammatory reactions, breast firmness, infections, granulomas, and fistulas.
1958: Milton T. Edgerton, M.D. and psychiatrist A.R. McClary publish an article about the psychological aspects of breast implant surgery. They studied 53 women who had the Ivalon sponge implants. They wrote: “Literally thousands of women in this country alone are seriously disturbed by feelings of inadequacy in regard to concepts of the body image.”
1962: Thomas Cronin and Frank Gerow, two plastic surgeons from Texas, perform the first breast augmentation on Timmie Jean Lindsey using a silicone gel-filled breast implant.
1963: First-generation silicone gel-filled breast implants; Dow Corning manufactures the Cronin-Gerow silicone gel-filled breast implants in a Hemlock, Michigan lab. The first-generation of implants were constructed using a two-piece, relatively thick shell, with a seam around the periphery. The shell 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: Laboratoires Arion manufactures the first saline implant in France. The goal was to allow implantation through a smaller incision than what was required for silicone gel implants. They produce the first “bouncy breast” result.
1968: The Heyer Schulte Corporation becomes the first domestic manufacturer of saline-filled breast implants.
1969: The Mentor Corporation is founded in Minneapolis, MN 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 shells, a round shape, and were filled with a less viscous silicone gel. These implants are softer and deemed more “lifelike”. The thin shells break more easily; once broken, total removal is difficult or impossible.
1970s: Canadian researches work on an inflatable implant for Dow Corning. The project is discontinued when they find that there is an 8% deflation rate during the first year.
1970s: Polyurethane foam covered implants became popular to prevent capsular contracture. The foam begins to disintegrate in the body almost immediately, making it difficult to remove and causing other complications.
1974: Don McGhan founds The McGhan Medical Corporation. McGhan initially worked in the lab for Dow Corning in 1963 when the first silicone gel breast implants were made. The McGhan Medical Corporation manufactured and sold silicone gel-filled breast implants.
1976: Congress passes the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. The FDA now has the authority to review and approve the safety and effectiveness data of new medical devices. Since silicone gel-filled breast implants had been on the market for almost 15 years already, they are “grandfathered.” Silicone gel implants remain available to all women for breast augmentation, but they were placed into Class II and reviewed through the premarket notification [510(k)] process. . Manufacturers of the implants will be required to provide safety and effectiveness data when asked to do so by the FDA.
1976: Between 12,000 and 40,000 women received breast injections in Las Vegas before the procedure was declared a felony under Nevada state law in 1976.
1977: Richard Mithoff, a Houston attorney representing a Cleveland woman, claims that her ruptured implants and subsequent operations caused pain and suffering for which she should be compensated. Mithoff won that first lawsuit against Dow Corning and received a $170,000 settlement. The case receives little publicity.
1977: Minnesota Mining and Manufacturing Company (3M) acquires McGhan Medical, and controls the production of the silicone gel breast implant product line.
1980s: Third-generation silicone gel-filed breast implants enter the market. Manufacturers focused on improving the strength and integrity of the shell. Both the McGhan Corporation and the Mentor Corporation developed a multilayer shell to reduce silicone gel bleed from intact implants, and to reduce implant rupture rates.
1980s: Soybean oil breast implants were developed by an American scientist. They became popular in Europe, but have still not been approved in the United States and Canada.
1980s: Ralph Nader’s Public Citizen Health Research Group in Washington, D.C. sends out warning signals that silicone gel-filled breast implants cause cancer.
1982 (January): The 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: A new McGhan Medical Corporation is formed to reacquire the assets held by 3M. McGhan Medical continues to manufacture breast implants.
1984: The Mentor Corporation acquires Heyer-Schulte of AHSC.
1984: The Maria Stern vs. Dow Corning lawsuit is heard in a San Francisco court. Maria Stern alleges that her systemic autoimmune disease is caused by her silicone breast implants. Maria Stern suffered from chronic fatigue and joint pain. Her doctors told her that the leaking silicone gel might have caused her health problems; though no scientific literature supported this theory, her doctors thought that it might at least be a possibility. Stern wanted to sue Dow Corning, which had made her implant, not just for manufacturing a defective product, but also for selling her something that had made her ill. This is the first time that silicone-induced medical problems are introduced in court, and ‘experts’ for the plaintiff theorized this “silicone gel-immune system connection”. Bolton got the court to agree to let him visit Dow Corning and search for documents. The silicone gel-immune system connection was something he could not prove, but he happened upon hundreds of memos on his visit to Dow Corning that detailed every aspect of the product and called into question the safety of long term gel implant use. (It is important to note that these documents did not show that implants were harmful.) After a month long trial, the jury awarded Maria Stern $211,000 in compensatory damages and $1.5 million in punitive damages. The evidence was sealed by a court order.
1985: First America Corporation becomes the new corporate parent of the silicone gel breast implant product line manufactured by McGhan.
1986: McGhan Medical changes its name to Inamed, a name meant to convey the concepts of “innovation” and “medicine.”
1988 (June): Six years after the 1982 proposal, in response to emerging safety concerns, the FDA re-classifies silicone gel breast implants to Cass III devices. This means that manufacturers will need to submit Premarket Approval (PMA) applications, and prove that the implants are safe. PMA applications were to be due by July 1991. After the PMAs are submitted by the manufacturers, the FDA has 180 days to evaluate the safety data. The PMAs must prove, with valid scientific data evaluated by the FDA, that their devices are safe and effective in order to keep them on the market.
1990s: The fourth-generation breast implants are designed and manufactured under more stringent criteria with improved quality control for shell thickness and gel cohesiveness. Manufacturers 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.
1990 (December): A congressional hearing headed by Representative Ted Weiss addresses the safety of silicone breast implants. This hearing also discusses the fact that not all of the information that the manufacturers have is available for public scrutiny due to the court order from the Stern verdict in 1984.
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 (July): The Brenda Toole vs. Baxter/Heyer-Schulte case is heard in Alabama court. Toole shows only preliminary symptoms of systemic autoimmune problems; but she has silicone in her lymphatic system according to plaintiffs’ witnesses, and they argue she has an increased risk of developing an autoimmune disease. The jury decides against Baxter/Heyer-Schulte and awards the largest settlement so far, $5.4 million, to Brenda Toole.
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 that breast implants are harmful either. Manufacturers are told to submit further data.
1991 (November): The FDA brings together 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 is composed of a broad range of experts 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 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.
1991 (December): To date, 137 individual lawsuits have been filed against Dow Corning.
1991 (December): The Mariann Hopkins vs. Dow Corning case is heard in San Francisco. The largest award yet, $7.34 million (of which $6.5 million was punitive damages), is given to Ms. Hopkins whose mixed connective-tissue disease is linked to her ruptured silicone gel breast implants. The lawyer for the case, Dan Bolton, wins the suit with the help of internal memos and studies from the Maria Stern lawsuit, in addition to new studies he recently obtained from Dow.
1991 (December): Violating a court order that the Dow Corning documents be kept under seal, Attorney Dan Bolton gives several of the internal documents to FDA commissioner, David Kessler, who has never seen the documents before.
1992 (January 6): Based upon these internal Dow Corning documents, FDA Commissioner, David Kessler calls for a voluntary moratorium of at least 45 days on the distribution or implantation of silicone gel-filled breast implants, while the FDA reviews new safety and effectiveness information that has been submitted. The manufacturers agree. At this point since the mid-1960s, about 2 million women have received silicone-gel filled breast implants. Mr. Kessler’s call for an implant moratorium became the spark that really ignited the implant controversy. Within weeks, hundreds of lawsuits become thousands of lawsuits.
1992 (February): Based upon new information, 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. But the panel does recommend the limited use of silicone breast implants for reconstruction only. The panel correctly concluded that no causal link has been established between autoimmune diseases and silicone breast implants.
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 (February): Dow Corning CEO, Lawrence Reed, is replaced by Keith McKennon.
1992 (February): Many of Dow Corning’s internal memos regarding silicone gel implants are released to the public.
1992 (March): One of Keith McKennon’s first moves, as Dow Corning’s CEO, was to take Dow Corning completely out of the breast implant business. Many Dow employees saw this an action as an implicit admission of guilt. But McKennon knew it had to be done, if only to send a signal to women that Dow Corning was not an uncaring company. Bristol-Myers Squibb and Bioplasty also decide to stop manufacturing silicone breast implants. McGhan and Mentor continue to manufacture breast implants.
1992 (March): Dow Corning sets up a fund for further research into the safety of breast implants. McKennon hired Ralph Cook, a Dow chemical scientist to begin evaluating the complexities surrounding breast implants and a possible connection to health problems.
1992 (April): The FDA concludes that none of the PMAs submitted for silicone gel breast implants contained sufficient data to support approval. FDA Commissioner, David Kessler, 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 adjunct clinical studies. Epidemiologic studies will be conducted to assess the risk of autoimmune disease.
1992 (May): First woman to receive silicone gel breast implants under the new rules of the Adjunct Study.
1992 (July): The FDA approves Mentor’s Adjunct Study protocol for its silicone gel-filled breast implants to be used for reconstruction and revision patients only.
1992 (December): The Pamela Jean Johnson vs. Bristol-Myers Squibb case is presented in Houston, argued by Texas attorney John O’Quinn. Pamela Johnson was 45 years old, with a ruptured implant and the usual symptoms of fatigue and joint pain. She had implants put in for purely cosmetic reasons when she was 29 years old. Ms. Johnson smoked a pack of cigarettes a day, and didn’t receive any medical treatment for her ailments until she was in her 40s. She hadn’t lost much time at work, despite her illness, which Expert witnesses and lawyers admitted amounted to nothing more than a “bad flu” all the time. The case was shown on Court TV. Despite conclusive scientific evidence, the jury finds Ms. Johnson’s ruptured silicone implants were linked to her mixed connective tissue disease, autoimmune responses, chronic fatigue, muscle pain, joint pain, headaches, and dizziness. Pamela Jean Johnson wins $25 million; $5 million awarded in actual damages and $20 million awarded for punitive damages. This huge verdict, and the TV publicity, created huge expectations among women, and within months, the number of breast-implant lawsuits nationwide had doubled.
1992 (December): To date 3,558 individual lawsuits have been filed against Dow Corning.
1993 (June): Dick Hazleton becomes CEO of 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): A Houston jury awards three women a total of $27.9 million in a case filed against 3M: $15 million in punitive damages and $12 million in compensatory damages for illness. The women are represented by attorney John O’Quinn, the same lawyer who won a multi-million dollar case against Bristol-Meyers Squibb just over one year earlier. The three women suffered from either atypical lupus, neurological impairment, and a “silicone induced” autoimmune problem.
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 (April): Preliminary approval to class action by Judge Pointer. Clears the way for women to start applying for claims in the settlement.
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 (September): Final approval of class action/global settlement from Judge Pointer.
1994 (December): By this date there have been 19,092 individual lawsuits filed against Dow Corning.
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 (February 1): The Gladys J Laas vs. Dow Corning case was heard in the District Court of Harris County Texas. The jury found Dow Corning guilty of misrepresentation and engaging in a false, misleading or deceptive act or practice that was a producing cause of the plaintiff’s injuries. Gladys Laas was awarded $5.2 million in compensatory damages, and her husband was awarded $1 million for loss of consortium. Dow Corning was liable for 80% of the verdict. Dow Chemical was liable for the remaining 20%.
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 (October): The Charlotte Mahlum vs. Dow Chemical case is presented in Reno, Nevada. This is the first case where Dow Chemical, the parent company of Dow Corning, is the sole defendant. (Dow Corning is jointly owned by Dow Chemical and Corning Inc. Dow Corning produced much of the silicone used in breast implants.) Dow Chemical did not make silicone or breast implants and insisted it had no liability. But lawyers for Charlotte Mahlum argued that Dow Chemical was just as responsible for the safety of implants as Dow Corning because it had performed studies on silicone for Dow Corning, and because its scientists had been aware that silicone could migrate through the body and cause harm. A jury finds that Dow Chemical Company is solely liable for health problems caused by the implants. 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.
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 autoimmune related illnesses.
1996 (April): 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.
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. 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.
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. Nevertheless, a state jury in the first class-action suit finds that Dow Chemical (which owns half of Dow Corning; the other half is owned by Corning, Inc.) knowingly deceived women by hiding safety information about the silicone in their implants.
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.”
1997 (December): 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 which are too dissimilar to group into one lawsuit.
1998 (March): The FDA approves Inamed’s (currently Allergan) Adjunct Study protocol for its silicone gel-filled breast implants to be used for reconstruction and revision patients only.
1998 (April): Two large Scandinavian studies which investigated the risk of neurologic disease in women with breast implants were published in the journal Neurology. “Neurologic Disease Among Women with Breast Implants” (1998;50:951-955) reviewed the medical record s of 1135 women who received cosmetic silicone gel breast implants between 1977 and 1992. The study failed to show an association between silicone breast implants and neurologic diseases. “Breast Implants and the Risk of Neurologic Disease” (1998;50:956-961) reviewed the records of 7433 women who had breast implants between 1972 and 1993. The study failed to show that silicone implants are linked to neurological disease.
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. This is the Core Study for submission P020056.
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, a seven-member panel of scientists known as the Independent Review Group (IRG) report there is no convincing evidence that silicone gel implants cause disease. (The U.K., along with other countries, have never removed silicone gel-filled breast implants from the market.)
1998 (November): Dow Corning files for bankruptcy reorganization, which includes the $3.2 billion previously agreed-to settlement and offers claimants several payout options.
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.
1998 (December): The Nevada Supreme Court upholds a compensatory damage award of $3.9 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.
1999 (January): A jury in a Washington Federal court awards $10 million in compensatory damages against the Bristol-Myers Squibb Co. to an attorney who claimed her implants caused scleroderma.
1999 (June): Congress asks the Institute of Medicine to set up an independent committee to evaluate the safety of silicone gel-filled breast implants. The Institute of Medicine is part of the National Academy of Sciences, the nation’s most prestigious scientific organization. The committee was made up of13 scientists. 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. The Institute of Medicine 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 (March): The FDA holds an Advisory Panel meeting to discuss three saline-filled breast implant PMAs. The Panel recommends that the FDA approve two of the PMAs but not the third.
2000 (May 10): The FDA approves the first PMAs for saline-filled breast implants: P990074 for Inamed and P990075 for Mentor. 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. This is the Core Study for submission P030053.
2000: National Cancer Institute finds no link between breast implants and breast cancer.
2000: During this year, 203,310 women undergo breast augmentation surgery.
2002 (July): The FDA holds an Advisory Panel meeting to update the Panel on post-market (after approval) information and data for the two approved saline-filled breast implant PMAs.
2002 (December): Inamed submits a PMA (P020056) 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 (P020056). 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 (P030053) to obtain approval for its silicone gel-filled breast implants.
2004: NCI finds no link between breast implants and any type of connective tissue disease.
2004: During this year, nearly 330,000 women undergo breast augmentation in the United States.
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: After initially agreeing to be acquired by Medicis Pharmaceutical Company, Inamed accepts a higher offer to merge with Allergan, Inc.
2006 (March): Inamed’s merge with Allergan becomes official.
2006: Allergan 410 approved in Canada.
2006 (November 17): The FDA approves Allergan’s PMA (P020056) and Mentor’s PMA for silicone gel-filled breast implants. Allergan’s Natrelle® (styles 10, 15, 20, 40, 45, 110, 115, 120) and Mentor’s Memory Gel® (styles 350 and 354) silicone gel-filled breast implants are now available for augmentation (in women at least 22 years old), in addition to 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 6 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. The conclusion: breast implants, while not perfect, remain safe and effective. The most common problems associated with breast implants remain: capsular contracture, reoperation and implant removal (with or without replacement). Other frequent complications include: implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval, and there remains no apparent association between silicone gel filled breast implants and connective tissue disease, breast cancer, or reproductive problems. This FDA document also 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.
The conclusion: breast implants, while not perfect, remain safe and effective. The most common problems associated with breast implants remain: capsular contracture, reoperation and implant removal (with or without replacement). Other frequent complications include: implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval, and there remains no apparent association between silicone gel filled breast implants and connective tissue disease, breast cancer, or reproductive problems.
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 MemoryShape® (formerly known as the Contour Profile Gel, CPG) highly cohesive, anatomically shaped silicone gel implant receives FDA approval. They have been approved for more than a decade outside of the U.S. and are filled with a uniquely formulated cohesive gel that enables shape retention, while providing a natural silhouette and youthful firmness. The combination of teardrop shape and distinct gel formulation creates the optimal balance of shape and feel. Mentor MemoryShape® Breast Implants are indicated for breast augmentation in women at least 22 years old and for breast reconstruction.