FDA Sends ‘Approvable’ Letter to Inamed for Application to Market Silicone Breast Implants
FDA on Wednesday sent an "approvable" letter to medical device company Inamed that said the agency would approve an application to market silicone breast implants, provided that the company meets certain conditions, USA Today reports (Rubin, USA Today, 9/22).
An FDA advisory committee in April voted 5-4 to recommend against agency approval of the Inamed application to market silicone breast implants to the general population because of concerns about a lack of long-term safety data. Committee members said that the safety data presented by Inamed were incomplete and that the company must submit more data on the causes of leaks in silicone breast implants, the effects of leakage and the long-term health risks of intact implants.
Inamed officials presented rupture data from a study of 940 women who received silicone breast implants manufactured by the company for reconstruction after breast cancer, replacement of previous implants or breast augmentation. According to the data, the silicone breast implants had an average annual rupture rate of 1.4% over three years. Inamed estimated that the silicone breast implants would have a rupture rate of 14% over 10 years based on the data (California Healthline, 4/13).
FDA officials in July indicated that they likely will approve an application from Mentor to market silicone breast implants, provided that the company meets certain conditions. A number of advocacy groups, such as the National Organization for Women, have issued complaints about how FDA has addressed the Mentor application. In addition, the Senate Health, Education, Labor and Pensions Committee has launched an investigation into whether conflicts of interest might have influenced the expected approval of the Mentor application (California Healthline, 8/10).
FDA said in a statement that, since the advisory committee recommended against approval of the Inamed application, the company "has provided FDA with additional information to address the primary safety concerns discussed by the panel" (USA Today, 9/22).
Inamed officials also said that the company will discontinue a certain silicone breast implant model that is more likely to rupture than other models (Lumpkin, AP/Las Vegas Sun, 9/21).
FDA officials said that the agency cannot provide information on the specific conditions included in the letter to Inamed (USA Today, 9/22). According to CQ HealthBeat, the letter indicates that FDA "intends to give final marketing approval once physician labeling is worked out" (CQ HealthBeat, 9/21).
Silicone breast implants likely will replace saline implants after they reach the market, with $75 million in sales expected in 2006, SunTrust Robinson Humphrey analyst Amit Hazan said (Henderson, Boston Globe, 9/22).
Inamed President Nick Teti said, "We respect the thoroughness of the FDA review process and are pleased with the decision." He added that the conditions included in the letter from FDA were "generally in line with our expectations" and said that the company plans to work with the agency to meet them (AP/Las Vegas Sun, 9/21).
However, Cindy Pearson, head of the National Women's Health Network, questioned how the company could have presented new long-term safety data on silicone breast implants to FDA only five months after the advisory committee recommended against approval of the Inamed application. She said, "It just doesn't make any sense. It actually frightens me. One way to interpret what I'm seeing is they (FDA) have just given up. They can't stand the constant applications, committee meetings."
FDA spokesperson Julie Zawisza said, "We are very accustomed to handling complicated and sometimes lengthy product evaluations, and we don't 'give up' just because we may be reviewing a controversial device" (USA Today, 9/22).