FDA and breast Implants a Regulatory History
Regulatory History of Breast Implants in the U.S.
||Congress 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.
||In 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 – April
||The FDA issued a final rule calling for submission of PMAs for silicone gel-filled breast implants.
|1991 – November
||The 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 – January
||The 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 – February
||Based 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 – April
||The 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 – July
||The FDA approved Mentor's Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
|1998 – March
||The FDA approved Allergan’s (formerly Inamed) Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
|1998 – June
||The 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
|2000 – March
||The 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 – May
||The FDA approved the first PMAs for saline-filled breast implants. 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 – August
||The 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 – July
||The 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 – December
||Allergan submitted a PMA for its silicone gel-filled breast implants.
|2003 – October
||The FDA held an Advisory Panel meeting to review Allergan’s PMA for its silicone gel-filled implants . In a 9 to 6 vote, the panel recommended approvable with conditions, including a minimum age requirement for augmentation.
|2003 – December
||Mentor submitted a PMA for its silicone gel-filled breast implants.
|2005 – April
||The 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 – November
||The 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 – January
||The FDA issued a Safety Communications 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 – June
||The FDA issued an Update 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.
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