Historical Timeline of Silicone Breast Implants

From 1969 to Present Day

 

July 28, 2005 –

Mentor received an “approvable with conditions letter” from the FDA for their MemoryGel silicone gel-filled breast implants.

April 13, 2005 –

In a 7-2 vote, FDA advisory panel recommended Mentor’s silicone implants approvable with conditions.

April 12, 2005 –

FDA advisory panel recommended nonapprovable status on Inamed’s silicone implants and encouraged further data collection.

April 11, 2005 –

FDA advisory panel reviewed Mentor and Inamed silicone breast implants. 

August 2004 –

Mentor and Inamed submitted additional data to amend their PMAs.

January 2004 –

“Not approvable” letter issued to Inamed.  Issuance of new Draft Guidance for Industry and FDA Staff: Saline, Silicone Gel, and Alternative Breast Implants. http://www.fda.gov/cdrh/ode/guidance/1239.aspx

October, 2003 –

Advisory panel voted 9-6 to recommend approval of Inamed’s PMA, with conditions.

2003 –

National Institute of Health (NIH) issues a report to Congress that states there was not sufficient evidence to support any relationship between breast implants and connective tissue disorders. 

2002-3 – 

Silicone breast implant PMAs submitted by Mentor and Inamed.

2000 –

National Academy of Sciences’ Institute of Medicine report finds no scientific evidence of an association between silicone breast implants and disease. 

September, 1994 –

Final approval of class action/global settlement.

June, 1994 –

The Mayo Clinic epidemiologic study is published in the New England Journal of Medicine, which finds no increased risk of connective tissue disease.

1993 –

Global settlement talks begin with manufacturers.

1992 –

FDA issues a voluntary moratorium on silicone gel breast implants. FDA restricts use of silicone implants to breast reconstruction clinical studies.  Mentor is the only company able to sell silicone products in the U.S. under an Adjunct Study.

1991 –

U.S. silicone controversy draws world-wide attention, due to lawsuits brought against several manufacturers.  FDA concludes that the implant manufacturers’ data does not prove the devices are safe or harmful, and manufacturers are told to submit further data.

1990 –

CBS-TV’s “Face to Face with Connie Chung” episode generates concern about silicone breast implants.

1980s –

Low bleed technology introduced.

1976 –

Double lumen implants are introduced.

1976 –

Congress gives FDA authority to regulate medical devices; pre-existing devices grandfathered pending future evaluation.

1969 –

Mentor (Heyer-Schulte) begins manufacturing implants.

1963 –

First gel-filled silicone shell for mammary augmentation is introduced.