FDA > CDRH > Breast Implants > Silicone Gel Implant Approvals (2006) > Silicone Gel-Filled Breast Implant Timeline

Silicone Gel-Filled Breast Implant Timeline

• Breast implants were preamendments devices. With the passage of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in 1976, these devices were reviewed through the premarket notification (510(k)) process. In 1988, all breast implants were classified as class III devices (premarket approval). However, in accordance with the law, they continued to be reviewed through the 510(k) process until FDA issued a rule calling for submission of premarket approval applications (PMAs).
   
• April 1991: FDA issued a final rule calling for submission of PMAs for silicone gel-filled breast implants.
   
• November 1991: A Panel meeting was held to discuss several silicone gel-filled breast implant PMAs. A voluntary moratorium was issued after the November 1991 Panel meeting, requesting that industry cease marketing of silicone-gel filled breast implants while FDA reviewed new safety and effectiveness information that had been submitted. In February 1992, a second Panel meeting was held to discuss that new information.
   
• FDA concluded that none of the PMAs submitted at that time contained sufficient data to support approval. However, FDA found that the continued availability of the devices for patients undergoing breast reconstruction or replacement of existing silicone gel-filled breast implants (revision) was necessary for the public health. FDA determined that, to address this public health need, access to silicone gel-filled breast implants for reconstruction and revision patients should continue to be available through Adjunct Studies. FDA denied approval of the devices for augmentation. Accordingly, silicone gel-filled breast were no longer marketed in the U.S. and were, thus, considered to be investigational devices.
   
• July 1992: FDA approved Mentor's adjunct study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
   
• March 1998: FDA approved Allergan’s (formerly Inamed) adjunct study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
   
• June 1998: 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 P020056.
   
• August 2000: 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 P0300053.
   
• December 2002: Allergan submitted a PMA (P020056) for its silicone gel-filled breast implants.
   
• October 2003: FDA convened a Panel meeting to review Allergan’s PMA (P020056). In a 9 to 6 vote, the Panel recommended approvable with conditions.
   
• December 2003: Mentor submitted a PMA (P030053) for its silicone gel-filled breast implants.
   
• April 2005: FDA convened a Panel meeting to review Allergan’s updated PMA and Mentor’s PMA. In a 5 to 4 vote, the Panel recommended not approvable for Allergan's PMA and, in a 7 to 2 vote, recommended approvable with conditions for Mentor's PMA.
   
• July 2005: FDA issued an approvable letter to Mentor for its silicone gel-filled breast implants.
   
• September 2005: FDA issued an approvable letter to Allergan for its silicone gel-filled breast implants.
   
• November 2006: FDA issued letters to Mentor and Allergan approving their PMAs for silicone gel-filled breast implants.

Updated November 17, 2006