Timeline – Mentor Silicone Breast Implants
1976 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.
1988 In response to emerging safety concerns, the FDA issued a final ruling (53,FR 23856) classifying breast implants to class III devices (21 CFR 878.3530), 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).
1989 FDA published a notice of intent to require premarket approval (54 FR 550).
1991 FDA required a PMA for these devices be filed with the Agency within 90 days (56 FR 14620).
April 1992 silicone breast implants are banned (moratorium)
July 1992 FDA approved Mentor’s Adjunct Study for it silicone gel-filled implants for reconstruction and revision patients only
Aug. 2000 FDA approved Mentor’s premarket Core Study (IDE study) at a limited number of sites for augmentation, reconstruction, and revision patients
Oct. 2003 Mentor submitted its PMA (P030053) for silicone gel-filled implants
April 2005 FDA held an Advisory Panel to Mentor’s PMA. In a 7-2 the panel recommended approved conditions for Mentor to add a minimum age for augmentation and Post-Approval Studies
Nov 17, 2006 FDA approved Allergan and Mentor PMAs for silicone gel-filled breast implants for augmentation, reconstruction, and revision. As conditions of approval each manufacturer had to conduct 6 post approval studies, these are listed as conditions of the approval in the Approval Order.
June 2011 The 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.
Aug. 2011 The FDA held an Advisory Panel on post-marketing issues with silicone gel breast implants.
June 2013 FDA approved Mentor’s MemoryShape Silicone Gel-Filled Breast Implant
2013 American Society of Plastic Surgeons (ASPS) commissioned a systematic literature review to be conducted by Tufts Center for Clinical Evidence Synthesis, funded by three breast implant sponsors, and the advisory board approved the final report on 8/1/2014. (The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding).
From 2014-2015, some studies (e.g. the large study) have been restructured into multiple smaller studies (case control studies, Re-Op study, MemoryGel and Shape combined). Case-control studies were later terminated after the release of Tufts’s evidence report.