Today the U.S. Food and Drug Administration announced approval of the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant, manufactured by Allergan, Inc. The implant is approved for augmentation in women at least 22 years old as well as to rebuild breast tissue in reconstructive surgery for women of any age.
FDA has approved implants for increasing breast size in women, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. Implants are also approved to correct or improve the result of a previous surgery. FDA has approved two types of breast implants for sale in the U.S.: saline (salt water solution)-filled and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness and shape.
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 implants as part of the company’s continued access study; Conduct a 10-year study of more than 2,000 women receiving the 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 the possible association between these implants, as well as other silicone gel-filled breast implants, and five rare diseases—rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma; Evaluate women’s perceptions of the patient labeling; and analyze the implants that are removed from patients and returned to the manufacturer.
The FDA based its approval of the Natrelle 410 on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (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, M.D., director of the FDA’s Center for Devices and Radiological Health.
The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery. The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape.
“The life of these devices varies according to the individual,” says Gretchen Burns, a nurse consultant at FDA’s Center for Devices and Radiological Health (CDRH). “All women with implants will face additional surgeries—no one can tell them when.” While a few women have kept their original implants for 20-30 years, “that is not the common experience.”
With today’s approval, there are now four FDA-approved silicone gel-filled breast implant products available in the U.S. manufactured by three companies: Allergan, Mentor, and Sientra. Allergan Inc. is based in Irvine, California.
FDA has a breast implants web page (www.fda.gov/breastimplants) with resources that include:
- Links to patient information and data for each product.
- Information about risks and complications
- Questions to ask health care professionals regarding breast implant surgery
- Contact information for manufacturers of FDA-approved breast implants and related professional organizations