Allergan Natrelle (Premarket application number: P020056) (Approved November 2006)
Description and Detailed Information Links:
Allergan’s Natrelle Silicone-Filled Breast Implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells. They are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.
- Patient Labeling for Augmentation Patients (2009) (PDF - 456KB)
- Patient Labeling for Reconstruction Patients (2009) (PDF -584KB)
- Physician Labeling (2009) (PDF - 370KB)
- Approval Order (PDF - 244KB)
- Summary of Safety and Effectiveness (PDF - 264KB)
- Consumer Information about P020056
- Post-Approval Studies (scroll to P020056)
Summary of Post-Approval Studies:
As conditions of approval, the FDA required Allergan to conduct six post-approval studies to characterize the long-term performance and safety of the devices. Due to the length of the studies required by the FDA, they have not all been completed. The post-approval studies for Allergan’s Natrelle Silicone-Filled Breast Implants included:
- Core Post-Approval Study (Core Study) – To assess long-term clinical performance of breast implants in women that enrolled in studies to support premarket approval applications. These studies were designed to follow women for 10 years after initial implantation.
- Large Post-Approval Study (Large Study) – To assess long-term outcomes and identify rare adverse events by enrolling more than 40,000 silicone gel-filled breast implant patients, following them for 10-years.
- Device Failure Study (Failure Study) – To further characterize the modes and causes of failure of explanted devices over a 10-year period.
- Focus Group Study – To improve the format and content of the patient labeling.
- Annual Physician Informed Decision Survey (Informed Decision Study) – To monitor the process of how patient labeling is distributed to women considering silicone gel-filled breast implants.
- Adjunct Study – To provide performance and safety information about silicone gel-filled breast implants provided to U.S. women from 1992-2006, prior to approval, when implants could only be used for reconstruction and replacement of existing implants.
The Allergan Core Study enrolled 715 patients and follow-up rates at 10 years post-implant were 66 percent. Allergan enrolled more than 40,000 women in their Large Study. In this study, Allergan has collected 2-year data for 71% of participants.
More information about the results of the post-approval studies is provided in the Update on the Safety of Silicone Gel-Filled Breast Implants (PDF - 1.45MB).