First silicone gel filled breast implants are devel- oped by Texas plastic surgeons Frank Gerow, MD, and Thomas Cronin, MD.
1962
Timmie Jean Lindsey (now 74) becomes the first woman to receive silicone breast implants. |
1976
May 28: The Medical Device Amendments are enacted, giving the FDA authority to regulate medical devices such as breast implants.
1977
Houston attorney Richard Mithoff wins the first lawsuit for a Cleveland woman who claims her ruptured implants and subsequent operations caused pain and suffering. She receives a $170,000 settlement from implant manufacturer Dow Corning. |
Ralph Nader's Public Citizen Health Research Group in Washington, D.C., warns that silicone breast implants cause cancer.
1988
June 24, 1988: The FDA puts silicone breast implants on its review schedule. |
1990
An episode of CBS-TV's "Face to Face with Connie Chung" generates public fear over potential danger of silicone gel-filled breast implants.
1992
In January, the FDA calls for a voluntary moratorium on the use of silicone implants.
In September, the FDA lifts the moratorium but restricts use of silicone implants to breast reconstruction and clinical studies.
1992
Global settlements talks begin with manufacturers.
1994
The Mayo Clinic epidemiologic study, published in the New England Journal of Medicine, finds no increased risk of connective-tissue disease and other disorders that were studied in women with silicone implants
1995
The American College of Rheumatology issues a statement saying the evidence is "compelling" that implants did not cause systemic disease.The "Harvard Nurses Epidemiologic Study" published in the New England Journal of Medicine, finds no increased risk of connective-Tissue disease or certain signs and symptoms of connective-tissue disease in women with silicone implants. |
1997
The Department of Health and Human Services asks the Institute of Medicine to conduct an independent, unbiased review of all past and ongoing scientific research regarding the safety of silicone breast implants.
The American Academy of Neurology reviews existing silicone implant studies and reports that "existing research shows no link between silicone breast implants and neurological disorders.
The Journal of National Cancer Institute publishes a review of multiple medical studies that conclude breast implants do not cause breast cancer.
1999
IOM releases a report prepared by an independent committee of 13 scientists who conclude that implants do not cause any major diseases such as lupus or rheumatoid arthritis. It releases a comprehensive report of the published literature and ongoing saline-filled and silicone gel-filled breast implants entitled "Safety of Silicone Breast Implants." |
2003
The FDA convenes a panel meeting to review a PMA submitted by Inamed Corporation for a silicone gel-filled breast implant. The panel vote is 9-6 to recommend approval of the PMA with certain conditions.
2004
Inamed Corportation announces Jan. 7 that it received a "Not Approved" letter from the FDA for its silicone gel-filled breast implant PMA. The FDA requests additional data for further review.
2005
On April 11-13, The FDA General Devices Panel holds hearings on silicone gel-filled breast implants PMAs from Mentor and Inamed corporations. The panel recommends approval of Mentor's application with several conditions. A final resolution by the FDA was still pending at PSN presstime. |
