Timeline – Saline 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).

1993 FDA issued a proposed rule requiring a PMA (58 FR 3436).

1995 Allergan began a premarket study on its saline breast implants, which was used as the basis for PMA approval in 2000.

Unknown date in the 90’s Mentor conducts the premarket Saline Prospective Study (SPS), a 3-year prospective study, which was the basis for PMA approval in 2000.

1999 FDA required a PMA or PDP for these devices to be filed with the Agency within 90 days (64 FR 45155).

March 2000 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.

May 2000 The FDA approved the first PMAs for saline-filled breast implants.  P990074 for Allergan (formerly Inamed) and P990075 for Mentor.  These implants were approved for augmentation in women age 18 and older and for reconstruction in women of any age.

July 2002 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.

Jan. 2011 FDA issued a statement on the occurrence of Anaplastic Large Cell Lymphoma (ALCL) cancer in women with breast implants. See here as well.

Nov. 2014 Ideal Implants are FDA approved.

FDA Timeline