Diana Zuckerman, PhD, National Center for Health Research: February 21, 2013
Yesterday the FDA quietly approved yet another questionable style of breast implants, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant made by Allergan, Inc.
The FDA based its approval on data from 941 women, which is a very small sample. The FDA reports that the complications from these implants are similar to those for other breast implants: pain and hardness caused by scar tissue (capsular contracture), the need for additional operations to fix implant problems, the need to remove the breast implants because of problems, uneven appearance (asymmetry), and infection. The studies also found cracks in the gel of some Natrelle 410 implants, which has not been found in other breast implants.
Unlike other breast implant approvals, the FDA did not hold a public Advisory Committee Meeting to discuss the data, nor did they make the study data public for these new breast implants. What are they afraid of? It seems likely that the FDA decided it was better to hide this information than to make it public at a meeting where implant patients could talk about the health problems that have been caused by these implants.
The silicone gel in the Natrelle 410 implant contains more cross-linking compared to the silicone gel used in Allergan’s previously approved Natrelle implant. This increased cross-linking results in a silicone gel that’s firmer. Cross-linking refers to the bonds that link one silicone chain to another. Some physicians believe this will make the implant last longer, but there is no evidence to support that because these implants have only been studied for 7 years.
The FDA admits that Allergan’s studies did not compare the safety and effectiveness of the Natrelle 410 implant to other previously approved silicone gel-filled breast implants on the market.
As a condition of approval for the Natrelle 410 breast implants, Allergan must:
- Continue to follow, for an additional five years, approximately 3,500 women who received the Natrelle 410 implants as part of the company’s continued access study;
- Conduct a 10-year study of more than 2,000 women receiving Natrelle 410 silicone gel-filled implants post-approval to collect information on long-term local complications (e.g., capsular contracture, reoperation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications);
- Conduct five case-control studies to evaluate whether women with Natrelle 410 implants, or other silicone gel-filled breast implants, are more likely to develop rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma;
- Evaluate women’s perceptions of the patient labeling; and
- Analyze the Natrelle 410 implants that are removed from patients and returned to the manufacturer.
Unfortunately, Allergan has not done a good job of doing post-market studies once their implants have been approved. And, even if they do these studies, by the time these studies are done to find out what the risks are, hundreds of thousands of women could have these inadequately studied devices in their bodies, and could have been harmed by them.
All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.