Monday, March 3, 2008

Breast Implants -- Some History

One of AOL News stories this morning is "Making a Comeback: 20 Trends to Watch in 2008". The number one listed is Silicone Implants. So I am going to try to look at "just the facts". I will try to cover some of the history of implants and the controversy.

Here is a time line of breast implants in the United States:

1962 -- Silicone gel-filled implants first available as a result of Tom Cronin, MD and Frank Gerow, MD's work with Dow Corning

1976 -- US Food & Drug Administration (FDA) given Congressional authority to regulate medical devices. Silicone gel-filled breast implants were "grandfathered in" pending further review.

1988 -- FDA classified breast implants as Class III medical devices. This set in motion a process requiring manufacturers to demonstrate safety and effectiveness in a pre-market approval application.

1962-1988 -- A number of different implant designs and modifications were developed. These included double-lumen, reverse double-lumen, triple-lumen, smooth surface, textured surface, polyurethane-covered, thick shell, thin shell, barrier shell, and implants of varying gel cohesivity. Also, during this time other manufactures joined Dow Corning in the marketplace. Some of these companies included Bioplasty, McGhan (became Inamed in 2001, then Allergan Corp in 2006), Mentor (absorbed American Heyer-Schulte in April 1984), and Surgitek .

1991 -- FDA held an advisory panel meeting on silicone gel-filled breast implants. In September, sent letter to manufacturers accepting Pre-market Approval Applications (PMAAs) for review with a listing of major and minor deficiencies.

Sept 1991 -- Bristol-Meyers Squibb Company announced its decision to withdraw from the breast implant market and closed the plastic surgery unit of its Surgitek subsidiary.

January 1992 -- FDA called for a 45 day moratorium on the sale and use of silicone gel-filled breast implants. Later moratorium extended until recently. Saline implant use allowed.

February 1992 -- FDA reconvened General and Plastic Surgery Devices Panel to review "new material". The Panel recommended limited availability of implants under carefully controlled clinical protocols for augmentation mammoplasty. The Panel recommended broader access for reconstruction patients.

March 1992 -- Bioplasty announced withdrawal of its PMAAs for its single and double-lumen gel-filled breast implants.

April 1992 -- Dow Corning Corporation announced it's withdraw for PMAAs for silicone gel-filled breast implants.

April 1992 -- FDA announced 1) extention of the PMAAs for silicone gel-filled breast implants for reconstruction under the public health extension while studies are conducted and 2) denial of PMAAs for silicone gel-filled breast implants for cosmetic purposes while studies are conducted (limited availability under investigational device study).

1992 -- Mentor began its Core and Adjunct Studies

1998 -- McGhan received approval to initiate its Core and Adjunct Studies.

2005 -- FDA approved Mentor's application to market its Memory Gel Implants.

In 2006 -- the FDA approved silicone implants for general clinical use in breast augmentation.

November 2007 -- FDA approved Allergan's application to market its Inamed silicone-filled breast implants.

REFERENCES

Silicone Breast Implants: Outcomes and Safety; Suppliment to Plastic and Reconstructive Surgery, Vol 120, No 7, Suppl 1, December 2007

ASPRS Breast Implant Resource Guide; May 1992

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