FDA approves new silicone-gel breast implant from Allergan
The Food and Drug Administration (FDA) on Feb. 20 approved the Natrelle 410 breast implant, a highly cohesive, anatomically shaped silicone-gel filled implant manufactured by Allergan, Inc., to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
"The ability to offer our patients a wide variety of treatment options is good for everyone," says ASPS President Gregory R.D. Evans, MD. "Innovation and patient safety drive our specialty, so we welcome the opportunity to provide yet another FDA-approved alternative for both breast augmentation and reconstruction patients."
As a condition of approval, Allergan is required to conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease. These conditions include:
■ Submission of the final report for the 10-year clinical study.
■ Continued follow-up through five years of patients in the Continued Access Revision/Reconstruction Expansion (CARE) and Continued Access studies.
■ A large study of newly enrolled patients followed for 10 years.
■ Participation in developing the National Breast Implant Registry (NBIR – a joint project of the FDA and ASPS which is being designed to include data from all three silicone breast implant manufacturers) and contributing data from the large new enrollment study upon implementation of the registry.
■ Completion of case-control studies on five rare disease outcomes.
■ Completion of a focus group study to evaluate the patient labeling.
■ Annual reporting of analyses conducted on all 410 devices explanted and returned to Allergan.
In addition to the Society's work with the FDA to establish the PROFILE Study to track cases of ALCL in women with breast implants, the FDA and ASPS are also partnering to establish a National Breast Implant Registry. The primary goal of the NBIR will be to create a device surveillance registry for persons with breast implants in the United States. The Registry will focus on collecting information on short- and long-term safety outcomes associated with all types of breast implants.
"In the process of launching PROFILE, it became apparent that the development of a National Breast Implant Registry would be beneficial to monitor the safety and efficacy of these devices in the patients who have used them," says The PSF President Charles Verheyden, MD, PhD. "A cooperative research and development agreement (CRADA) has since been signed with the FDA and weekly progress is being made in reviewing historical data, validating questions, and discussing the mechanics of harvesting and utilizing data."
The FDA based its approval on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including capsular contracture, re-operation, implant removal, asymmetry and infection. In addition, investigators observed fissures (cracks) in the gel of some Natrelle 410 implants. This is a characteristic called gel fracture and is unique to this implant.
"It's important to remember that breast implants are not lifetime devices. 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," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health.
"The data we reviewed showed a reasonable assurance of safety and effectiveness," said Shuren. "We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness."
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. The clinical significance of this type of silicone gel is not known.
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. Therefore, these implants cannot be directly compared to any previously FDA-approved implant.
The approval makes the Natrelle 410 the fourth FDA-approved silicone gel-filled breast implant available in the United States.
For more information, go to www.fda.gov/breastimplants.