Medical Devices

FDA Breast Implant Consumer Handbook – 2004 - TIMELINE OF BREAST IMPLANT ACTIVITIES

  • May 28, 1976: The Medical Device Amendments were enacted, giving FDA authority to regulate medical devices such as breast implants, which were already on the market.
  • July 23, 1976: The FDA General and Plastic Surgery Devices Panel (the Panel) recommended that breast implants be placed in class II, requiring general controls and performance standards. Under the law, there are three regulatory categories for medical devices. Class I devices are usually simple devices whose risks can be controlled by labeling and the manufacturing process. Class II devices require additional measures, called special controls, to control risks. Special controls may include performance standards, postmarket surveillance studies, user education, or other measures. If there is a lack of information about whether a device is safe and effective, it is put into class III, and the highest level of premarket review is required. Class III devices include innovative (creative), medical breakthrough, new technology devices, and devices with poorly established or questionable safety and effectiveness.
  • January 19, 1982: Because of some reports of adverse events in the medical literature, FDA announced a proposal to place breast implants in class III. Class III devices have strict controls for safety and effectiveness.
  • June 24, 1988: FDA classified all breast implants into class III. After a prescribed waiting period of 30 months, FDA could require the submission of PMAs in which manufacturers present data showing the safety and effectiveness of these devices.
  • January 6, 1989: FDA published a notice of intent to require submission of PMAs for saline-filled and silicone gel-filled breast implants.
  • January - March 1989: An unpublished study showed that polyurethane foam, which was used as a coating on certain types of silicone gel-filled breast implants, would degrade and release 2-toluene diamine (TDA), a chemical known to cause cancer in animals, under conditions of high temperature and alkalinity (high pH). FDA requested specific information from the manufacturer about the chemical make up and safety testing of polyurethane foam. Shortly afterwards, the manufacturer of polyurethane foam-coated breast implants removed them from the market.
  • May 17, 1990: FDA issued a proposed 515(b) regulation (call for safety and effectiveness data) in the Federal Register on silicone gel-filled breast implants.
  • February 1-2, 1991: FDA sponsored a Conference on Silicone in Medical Devices. This was an exchange of scientific information and views on the applications of silicone in medical devices.
  • April 10, 1991: FDA published a final 515(b) regulation in the Federal Register that required manufacturers of silicone gel-filled breast implants to submit PMAs with data showing a reasonable assurance of safety and effectiveness of the implants by July 9, 1991.
  • June 1991: FDA required the company of polyurethane foam-coated breast implants to conduct research on the material. In taking this action, FDA made the first use of new postmarket surveillance authority under the Safe Medical Devices Act of 1990.
  • July 31, 1991: The Panel reviewed FDA's risk assessment of polyurethane foam coating. The Panel found that the risk of cancer, if any, appears small and would very likely be outweighed by the surgical risk involved in removing a polyurethane-coated breast implant.
  • August 22, 1991: FDA determined that PMAs submitted by three companies of silicone gel-filled breast implants did not contain sufficient data to warrant a full review.
  • September 26, 1991: FDA issued a Notice in the Federal Register requiring distribution of information to patients on the risks associated with saline-filled and silicone gel-filled breast implants.
  • November 12-14, 1991: FDA convened the Panel to consider whether the PMA data received from the companies was sufficient to establish that the silicone gel-filled breast implants are safe and effective. Despite the lack of data, the Panel voted unanimously (complete agreement) to advise FDA that the implants filled a public health need for breast reconstruction and revision for medical or surgical reasons and that the implants should continue to be available while the companies collected additional data.
  • January 6, 1992: FDA called for a voluntary moratorium (delay) on the use of silicone gel-filled breast implants until new safety information could be thoroughly reviewed by the Panel.
  • February 18, 1992: The Panel met again to review new information on silicone gel-filled implants. This included case reports of autoimmune diseases, information not included in the companies' original submissions to FDA, and evidence that some early models may have leaked excessively.
  • March 19, 1992: Dow Corning withdrew from the silicone implant market but continued to supply gel to one implant company.
  • April 16, 1992: FDA lifted the voluntary moratorium on breast implants. FDA also announced its decision to allow access to silicone gel-filled breast implants only under controlled clinical studies for reconstruction after mastectomy, correction of congenital deformities, or replacement of ruptured silicone gel-filled implants due to medical or surgical reasons. Until the these clinical studies (adjunct studies) could be submitted and reviewed, FDA authorized temporary limited distribution of silicone gel-filled implants for reconstructive patients on an urgent need basis with a very detailed informed consent form. FDA denied applications for using silicone gel-filled breast implants for augmentation but planned that the companies would later conduct clinical trials that would include a limited number of augmentation patients (core or IDE studies).
  • July 24, 1992: FDA approved Mentor Corporation's adjunct study protocol for silicone gel-filled breast implants for reconstruction and revision patients only.
  • December 1992: Dow Corning announced that it would no longer make five implant grades of silicone for sale after March 31, 1993, but that it would continue to manufacture 45 other medical grades of silicone materials.
  • January 8, 1993: FDA published a 515(b) proposal in the Federal Register calling for safety and effectiveness data for saline-filled breast implants.
  • June 2, 1994: FDA sponsored a Part 15 Hearing on saline-filled breast implants to hear testimony from all interested parties concerning the timing of the agency's review of the safety and effectiveness of saline-filled breast implants. FDA promised to make a decision by the end of the year.
  • July 15, 1994: FDA granted conditional approval of an IDE pilot study of 50 patients for a breast implant filled with a purified form of soybean oil (TrilucentT implant).
  • October 21, 1994: FDA sponsored the workshop Alternatives to Silicone Breast Implants. The workshop provided a forum for FDA to present a draft guidance document for testing requirements for alternative breast implants.
  • December 23, 1994: FDA issued a Talk Paper describing the types of studies required to demonstrate the safety and effectiveness of saline-filled breast implants and the date the studies are expected to be completed. Preclinical data were submitted throughout 1995. Final clinical data were expected by early 1999.
  • April 20, 1995: FDA updated the patient information sheet (entitled "Information for Women Considering Saline-Filled Breast Implants") on the risks of saline-filled breast implants that companies give to physicians who, in turn, provide them to patients considering implant surgery.
  • January 11, 1996: FDA sent a letter to companies of silicone gel-filled breast implants detailing the type of information needed for core studies (IDE studies) of the silicone gel-filled breast implants for augmentation, reconstruction, and revision patients.
  • September 4, 1996: Poly Implants Protheses (PIP)'s 510(k) for their saline-filled breast implants was cleared for marketing by FDA.
  • September 19, 1996: FDA received a Citizen's Petition from the Y-Me National Breast Cancer Organization and other related organizations requesting that the FDA ease restrictions on the availability of silicone gel-filled breast implants for women who choose reconstruction after a mastectomy and who have other special medical needs. FDA denied this petition.
  • February 11, 1997: FDA received a Citizen's Petition from CanDo Organization requesting that the FDA revoke permission granted to companies to make silicone gel-filled breast implants available to women with breast cancer and women who previously had implants. FDA denied this petition.
  • May 20, 1997: Hutchinson International's 510(k) for their saline-filled breast implants was cleared for marketing by FDA.
  • 1997: The Department of Health and Human Services (DHHS) asked the Institute of Medicine (IOM) to conduct an independent, unbiased review of all past and ongoing scientific research regarding the safety of silicone breast implants. A committee of experts in relevant scientific and clinical areas was asked to evaluate past and ongoing studies of the relationship, if any, between implants and systemic disease; assess the biological and immunological effects of silicone and other chemical components of breast implants; assess the impact of breast implants, if any, on the offspring of women with implants; and assess the accuracy of mammograms.
  • Spring 1998: FDA completed a study to assess the rupture rate of silicone gel-filled breast implants.
  • March 30, 1998: FDA approved Inamed Corporation's adjunct study protocol for silicone gel-filled breast implants for reconstruction and revision patients only.
  • May 6, 1998: Mentor Corporation and its subsidiary, Mentor Texas, signed a consent decree of permanent injunction, promising to manufacture its breast implants in compliance with the Quality System Regulation. The Quality System Regulation is critical in helping to assure that medical devices are consistently high in quality and are safe and effective. FDA permitted Mentor Corporation to continue marketing its breast implants because the deficiencies in Mentor Corporation's manufacturing process were not shown to result in a significantly increased risk to women who received this company's breast implants.
  • June 5, 1998: FDA approved Inamed Corporation's IDE study for silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
  • November 12, 1998: FDA received a Citizen's Petition from Hyman, Phelps & McNamara requesting that FDA either withdraw the proposed rule calling for PMAs or PDPs for the saline-filled breast implant or reopen the comment period to allow interested persons to address the information that has become available since the publication of the 1993 proposed call for PMAs or PDPs. FDA denied this petition.
  • February 1, 1999: Silimed's 510(k) for their pre-filled and inflatable saline-filled breast implants was cleared for marketing by FDA.
  • June 22, 1999: The IOM released a comprehensive report of the published literature and ongoing studies on both saline-filled and silicone gel-filled breast implants entitled Safety of Silicone Breast Implants. The IOM made a clear distinction between local complications and systemic health concerns. The IOM determined that there was insufficient evidence to establish that either or both types of breast implants cause systemic health effects, such as autoimmune disease, and that there were no new health or safety issues associated with the use of both types of implants. The IOM also concluded that local complications are "the primary safety issue with silicone breast implants." These local complications, which include rupture, pain, capsular contracture, disfigurement, and serious infection, may lead to medical interventions and repeat surgeries.

    The IOM report, Safety of Silicone Breast Implants, is available for sale from National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055 or call 800-624-6242 or 202-334-3938 or through the web at http://books.nap.edu/catalog/9602.html. The IOM report may also be read at the same website for free. A consumer booklet on the IOM study, Information for Women about the Safety of Silicone Breast Implants, can be purchased from the National Academy of Sciences on their website at http://books.nap.edu/catalog/9618.html or read at the same website for free.
  • June 30, 1999: FDA received a Citizen's Petition from Anne Stanswell requesting that FDA ban the use of the silicone gel-filled breast implants. FDA denied this petition.
  • October 1999: FDA issued a draft guidance document entitled, "Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses." This guidance document was for saline, silicone gel, and alternative breast implants and replaced FDA's previous three guidance documents for the individual types of breast implants.
  • August 19, 1999: FDA published a final 515(b) regulation in the Federal Register that required manufacturers of saline-filled breast implants to file PMAs or completed PDPs within 90 days. The PMAs or PDPs were to include data showing a reasonable assurance of safety and effectiveness of the implants. One of the reasons for the time span between the January 1993 proposed call for PMAs/PDPs and this final one was to give companies time to collect data on their preamendments or 510(k)-cleared saline-filled breast implants.
  • December 17, 1999: FDA approved Silimed's IDE study for saline-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
  • March 1-3, 2000: FDA convened a Panel meeting to review a PMA submitted by Mentor Corporation, Inamed Corporation, and PIP for their saline-filled breast implants and make a recommendation to the FDA whether the PMAs are approvable. The Panel recommended that Mentor Corporation's and Inamed Corporation's PMAs be approved with conditions and that the PIP PMA be disapproved. Additionally, a day of this Panel meeting was dedicated to obtaining public input on patient labeling. The transcript for this Panel meeting is available at CDRH Advisory Committees.
  • April 28, 2000: FDA approved PIP's IDE study for saline-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
  • May 10, 2000: FDA granted approval of Mentor Corporation's and Inamed Corporation's saline-filled breast implant PMAs. Both PMAs included data on the types and rates of local complications experienced by patients. The 3-year complication rates are also summarized in our May 10, 2000 press release. Despite complications experienced by some women, the majority of those women still in the Inamed Corporation and Mentor Corporation studies after three years reported being satisfied with their implants.

    Both PMAs were approved for females for the following indications: breast augmentation (a woman must be at least 18 years old) and breast reconstruction. The approval letter, the labeling at the time of approval, and the Summary of Safety and Effectiveness (SSED) are available at Mentor Corporation Saline-Filled and Spectrum® Mammary Prostheses - P990075 for Mentor Corporation and at McGhan Medical RTV Saline-Filled Mammary Implant - P990074 for Inamed Corporation.
    Updated clinical data from Mentor Corporation's and Inamed Corporation's ongoing postapproval studies for these PMAs are available in the patient labeling on FDA's website at Breast Implants, as well as on the websites for both companies.
  • May 26, 2000: FDA approved Hutchison's IDE study for saline-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
  • August 2, 2000: FDA approved Mentor Corporation's IDE study for silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
  • September 8, 2000: FDA approved Inamed Corporation's IDE study for more-cohesive (firmer) silicone gel-filled breast implants for a limited number of augmentation and reconstruction patients at a limited number of sites.
  • June 29, 2001: FDA approved Mentor Corporation's IDE study for more-cohesive (firmer) silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
  • July 18, 2001: FDA approved Mentor Corporation's IDE study for saline/silicone gel-filled breast implants for a limited number of reconstruction patients at a limited number of sites. These implants have an inner lumen filled with saline and an outer lumen filled with silicone gel.
  • August 13, 2001: FDA issued an updated breast implant guidance document entitled, "Guidance for Saline, Silicone Gel, and Alternative Breast Implants." This version replaced the October 1999 version.
  • September 5, 2002: FDA approved Silimed's IDE study for silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
  • December 30, 2002: Inamed Corporation submitted a PMA for their silicone gel-filled breast implants.
  • February 11, 2003: FDA issued an updated breast implant guidance document entitled, "Guidance for Saline, Silicone Gel, and Alternative Breast Implants." This version replaced the August 2001 version.
  • April 29, 2003: FDA approved CSS' IDE study for saline-filled breast implants for a limited for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites.
  • May 14, 2003: FDA approved Inamed Corporation's IDE study for saline/silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. These implants have an inner lumen filled with saline and an outer lumen filled with silicone gel.
  • August 22, 2003: Consent Decree with Mentor Corporation was vacated by court. Mentor satisfied FDA's requirement that Mentor's Irving, Texas facility be in continuous compliance for at least five years with the FDA's current good manufacturing practices requirements.
  • October 14-15, 2003: FDA convened a Panel meeting to review a PMA submitted by Inamed Corporation for a silicone gel-filled breast implant and to make a recommendation to the FDA whether the PMA is approvable. The PMA included data collected in their core clinical study (the IDE), as well as information from the larger adjunct study, medical device reports from a variety of databases, and published scientific literature. Approximately 120 members of the public also were afforded an opportunity to address the Panel. The Panel voted nine to six to recommend approval of the PMA with certain conditions.
    A copy of the Panel meeting agenda, Panel package, Panel roster, FDA slides, brief summary of Panel meeting, and complete transcript are available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=388.
  • November 3, 2003: FDA received a Citizen's Petition from Kim Gandy, Sidney Wolfe, M.D., and Cynthia Pearson requesting the FDA to stop the review of the Inamed Corporation silicone gel-filled breast implant PMA until the information described in their petition was provided. FDA denied the petition because FDA is required to complete the review of an outstanding application and make a decision.
  • November 18, 2003: FDA received a Citizen's Petition from Marlene Keeling requesting the FDA to stop the review of any silicone gel-filled breast implant PMA until the information described in their petition was provided. FDA denied the petition because FDA is required to complete the review of an outstanding application and make a decision.
  • December 12, 2003: Mentor Corporation submitted a PMA for their silicone gel-filled breast implants.
  • January 7, 2004: As noted on their website at http://www.inamed.com, Inamed Corporation announced that they received a "Not Approvable" letter from FDA for their silicone gel-filled breast implant PMA and that the letter outlines the additional information that Inamed Corporation must provide prior to the FDA's further review of its PMA. FDA cannot discuss the specific details of that letter because it is considered confidential material.
  • January 13, 2004 (pre-publication release date of January 8th): FDA issued an updated (and in draft) guidance document entitled, "Saline, Silicone Gel, and Alternative Breast Implants." The substantive new recommendations in the draft guidance document involve mechanical testing, modes and causes of rupture, clinical study information, postapproval requirements, and labeling. FDA also issued a press release regarding this guidance document. The press release is available at FDA Provides Pathway for Sponsors Seeking Approval of Breast Implants. After the comment period, the guidance document will be finalized and then replace the February 2003 version.

Page Last Updated: 08/20/2013
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