Tony Lambert delphine1939@videotron.ca

9 Janvier 2007

1999/07/14 13:17 The following press release was issued today by the National Center for Policy Research for Women & Families:

In its efforts to win FDA approval for silicone gel breast implants at hearings to be held on October 14th and 15th, implant manufacturer Inamed submitted hundreds of pages of research information from three

especially those with breast cancer. Released by the FDA October 10th, the company``s own research indicates high complication rates for the first three years, including the need for additional surgery for 46% of breast cancer patients.

Inamed``s "Core" study included 221 breast cancer reconstruction patients, 494 augmentation patients, and 225 revision (replacement) patients. According to the FDA, their complication rates are very high. For example, 46% of reconstruction patients underwent at least one re-operation within 3 years, 25% had removal or replacement, 6% had a diagnosed ruptured implant, 6% had breast pain, and 6% were diagnosed with necrosis, a painful and disfiguring condition where the skin or tissue dies. Complications were lower but still substantial for augmentation patients (for example, 21% with re-operations, and 1% diagnosed rupture) and revision patients (33% with re-operations and 4% diagnosed ruptures). The FDA assumed that the rupture rate was higher than reported, since three out of four ruptures would not be diagnosed unless a woman underwent an MRI.

The largest study, called the Adjunct Study, enrolled 15,465 reconstruction patients and 9,881 "revision" patients (who had replaced their previous breast implants with new Inamed silicone gel implants). The Adjunct Study was the compromise developed by the FDA to enable large numbers of mastectomy patients and women with broken gel implants to use silicone gel implants at a time when the company had not proven that their product was safe.
Although women wanting silicone breast implants were required to participate in the Adjunct Study, the company apparently made little effort to comply with this requirement: barely half (54%) of the breast cancer patients who received Inamed implants stayed in the study for one year. Even fewer