Based on seven years of data from 941 women, the FDA has approved Allergan, Inc.’s Natrelle 410 silicone-gel breast implant for breast augmentation and reconstructive surgery. Allergan, as part of the FDA-approval process, has agreed to officiate over a series of post-approval studies. These studies will assess long-term safety, and effective outcomes as well as any associated risks with rare diseases.
According to Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health, “Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential.”
Other conditions Allergan must meet for FINAL FDA approval include submission of a report based on a 10-year clinical study, and participation in developing the National Breast Implant Registry (NBIR) in collaboration with the FDA and the American Society of Plastic Surgeons (ASPA).
“At Premier Plastic Surgery we are very excited about the FDA announcement that the 410 cohesive gel implant is more widely available. I’ve used this implant for the last 7 years for breast reconstruction cases and the most complicated breast augmentation patients thru an FDA research protocol and I’m very happy the FDA has allowed the use of this implant for more straight forward breast augmentation cases. In plastic surgery there are numerous situations in which the quality of the final result depends in part on the devices and technologies available. While the cohesive anatomical implant won’t replace the round gel implant and is not appropriate for all, it will allow better final results for a significant group of patients.” - Dr. Brad Storm.
The basis of this registry is to track cases of breast implants among women, and create a device surveillance registry to collect data on short and long-term safety outcomes associated with breast implants. Overall, the main focus is to monitor the safety and efficacy of these devices in patients who have used them. Since initiating the 10-year profile study, a cooperative research and development agreement has been signed by the FDA and the ASPS. Review of historical data, discussions on the aggregation of data and validation of inquiries continue on a weekly basis.
According to Shuren, the FDA will continue to look at results from the post-approval study to rate long-term safety and effectiveness. The silicone gel used in the Natrelle 410 implant contains more cross-linking than Allergan’s previously approved implant, resulting in an implant that is significantly firmer. The Natrelle 410 breast implant is the fourth FDA-approved silicone gel implant to be available in the United States.