Medical Devices

Regulatory History of Breast Implants in the U.S.

 

YearEvent
1976Congress passed the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.  Breast implants were placed into Class II and reviewed through the premarket notification [510(k)] process.
1988In response to emerging safety concerns, the FDA re-classified breast implants to class III devices (requiring premarket approval). However, in accordance with the law, they continued to be reviewed through the 510(k) process until the FDA issued a rule calling for submission of premarket approval applications (PMAs).
1991 - AprilThe FDA issued a final rule calling for submission of PMAs for silicone gel-filled breast implants.
1991 - NovemberThe FDA held an Advisory Panel meeting to discuss several PMAs for silicone gel-filled breast implants. While the panel concluded that the manufacturers had failed to provide adequate safety and effectiveness data for their implants, they unanimously recommended that the FDA permit the implants to remain on the market.
1992 - JanuaryThe FDA announced a voluntary moratorium on silicone gel-filled breast implants, requesting that manufacturers stop supplying them and surgeons stop implanting them, while the FDA reviewed new safety and effectiveness information that had been submitted.
1992 - FebruaryBased on new information, the FDA held a second Panel meeting to re-evaluate the safety of silicone gel-filled breast implants.  This time the panel recommended that silicone gel-filled breast implants be removed from the market pending further evaluation of the new data.
1992 - AprilThe FDA concluded:
  • None of the PMAs submitted for silicone gel-filled breast implants contained sufficient data to support approval.
  • Access to silicone gel-filled breast implants should continue for patients undergoing breast reconstruction or for replacement of existing silicone gel-filled breast implants (revision).  Implants used for these indications should be considered to be investigational devices, and women who received them should be followed through adjunct clinical studies.
1992 - JulyThe FDA approved Mentor's Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 - MarchThe FDA approved Allergan’s (formerly Inamed) Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 - JuneThe FDA approved Allergan’s investigational device exemption (IDE) study (i.e., Core Study) for 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.
2000 - MarchThe FDA held an Advisory Panel meeting to discuss three saline-filled breast implant PMAs.  The Panel recommended that the FDA approve two of the PMAs but not the third.
2000 - MayThe FDA approved the first PMAs for saline-filled breast implants.  P990074 for Allergan (formerly McGhan) and P990075 for Mentor.  These implants were approved for augmentation in women age 18 and older and for reconstruction in women of any age.
2000 - AugustThe FDA approved Mentor's IDE study (i.e., Core Study) for 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.
2002 - JulyThe FDA held an Advisory Panel meeting to update the Panel on postmarket (after approval) information and data for the two approved saline-filled breast implant PMAs.
2002 - DecemberAllergan submitted a PMA (P020056) for its silicone gel-filled breast implants.
2003 - OctoberThe FDA held an Advisory Panel meeting to review Allergan’s PMA for its silicone gel-filled implants (P020056). In a 9 to 6 vote, the panel recommended approvable with conditions, including a minimum age requirement for augmentation.
2003 - DecemberMentor submitted a PMA (P030053) for its silicone gel-filled breast implants.
2005 - AprilThe FDA held an Advisory Panel meeting to review Allergan’s updated PMA and Mentor’s PMA. In a 5 to 4 vote, the panel did not recommend approval of Allergan's PMA (due to a concern with one style in the application). In a 7 to 2 vote, the panel recommended approvable with conditions for Mentor's PMA. The panel recommended that FDA require conditions including a minimum age requirement for augmentation and Post-Approval Studies. 
2006 - NovemberThe FDA approved Allergan and Mentor’s PMAs for silicone gel-filled breast implants.  This was the first time silicone gel-filled breast implants were available for augmentation, in addition to reconstruction and revision, since the moratorium was established in 1992.  As conditions of approval, each manufacturer was 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.
2011 - JanuaryThe FDA issued 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 scar capsule adjacent to the implant.
2011 - JuneThe FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. It included 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.
2011 - AugustThe FDA held an Advisory Panel meeting to discuss and receive recommendations on postmarketing issues related to silicone gel-filled breast implants. Also discussed at this meeting were innovative methodological approaches to postmarket studies regarding silicone gel breast implants, as well as key long-term safety issues associated with silicone gel breast implants in the real-world setting.
2012 - MarchThe FDA approved Sientra Inc.’s PMA for a silicone gel-filled breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their silicone gel-filled breast implant and to answer scientific questions that the premarket clinical trial was not designed to answer.
2013 - FebruaryThe FDA approved Allergan's PMA for a silicone gel-filled breast implant that uses a more cohesive silicone gel, compared to their previously approved breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their breast implant and to answer scientific questions that the premarket clinical trial was not designed to answer.
2013 - JuneThe FDA approved Mentor's PMA for a silicone gel-filled breast implant that uses a more cohesive silicone gel, compared to their previously approved breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their breast implant and to answer scientific questions that the premarket clinical trial was not designed to answer.

 

Page Last Updated: 09/25/2013
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