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FDA Use of Company Data to Support Safety of Breast Implants Questioned

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The National Research Center for Women and Families (NRC) recently called the FDA on the carpet. According to a recent article by the Associated Press in The Washinton Post (January 5, 2012), the FDA did not include what the NRC believes to be important data in their conclusion that “silicone-gel implants are basically safe as long as women understand they come with complications.”

Data from two long-term studies showed that silicone breast implants not only fail over time, but that women who have received the implants do not necessarily fare well vis à vis their general emotional, mental and physical health after getting the implants. The FDA did say in their report that “More than one in five women who get implants for breast enhancement will need to have them replaced within five years.”

In addition, the group questioned why data presented by the FDA appeared to show problems with implants as declining over time, when the reverse is true. In a letter following the August FDA meeting on silicone gel breast implant safety, the NRC questioned why data on rupture rates, connective tissue diseases, and other complications were not included in the meeting discussion. Diana Zuckerman, president of the NRC, has written Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, for an answer.

Allergan Inc. of Irvine, Calif., and Mentor, a unit of Johnson & Johnson, based in New Brunswick, N.J., manufacturers of the implants, are waiting with baited breath for an answer as well because much of the data used was from their reports. Quality of life studies performed by both companies, Allergan and J&J, of women who had received the silicone implants showed some negative follow-on results in the area of mental, emotional and physical health and rates of rupture and breakage dropping over time.

Silicone-gel breast implants were banned by the FDA in 1992. For more than ten years, only saline-filled implants were available. After extensive scientific research allayed concerns about the use of silicone-gel in implants possibly causing cancer, silicone-gel implants were placed on the market again in 2006.