FDA approves new "Gummy Bear" silicone breast implant
A new silicone breast implant is hitting the market.
The Food and Drug Administration has approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant. The implant is approved for the purpose of breast augmentation in adults 22 and older and in women of all ages who are undergoing a breast reconstruction following cancer.
Natrelle 410 implants are manufactured by Allergan, Inc.
Dr. Oren Lerman, a plastic surgeon at Lenox Hill Hospital's Institute for Comprehensive Breast Care in New York City, explained to CBSNews.com that this is the latest in a generation of silicone implants that may provide a more natural "tear-drop" look compared to other silicone options. The implants contain more cross-linking in the silicone gel than earlier models which makes it more cohesive, which in turn makes the implants firmer.
Doctors sometimes refer to these implants as "Gummy Bear" implants because of their feel and consistency when held outside the body, Lerman said.
A similar form-stable implant from Sientra was approved last year, he added.
The FDA's approval was based on seven years of data collected from 941 women. Side effects are similar to other breast implants, including tightening of the area around the implant, the need for re-operation or removal, an uneven appearance or infection. The investigators also observed cracks in some of the implants, which is characteristic of the silicone gel and is unique to this implant.
"The data we reviewed showed a reasonable assurance of safety and effectiveness," Dr. Jeffery Shuren, director of the FDA's Center for Devices and Radiological Health, wrote in a written statement. "We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness."
The studies did not compare safety data of the new Natrelle 410 to that of other implants on the market, the FDA said.
The FDA wants more studies, including a 10-year-study to collect information on long-term complications.
Lerman said these types of implants have been available for years in other countries besides the United States. The pros of the new implant, he said, is they give a more anatomical-looking, natural result and they are less prone to leading to wrinkling and visible edges that other implants may cause. The downsides, he said, is some women may not like the added firmness, and the implant requires a slightly larger incision.
These decisions will be very dependent on the patient's preferences, he said. He noted the implant may be especially beneficial for women who survived breast cancer and undergo reconstruction, because it wouldn't have to be fitted under the breast tissue which had been removed.
"These new form-stable implants are not necessarily a better product or a better choice for all women," he said. "They are just a new product and a new choice for women that fills a certain need and makes up for certain shortcomings."
Like other implants, the new Natrelle implants are not considered lifetime devices, according to the FDA. The longer a woman has them, the more likely she'll develop complications and need more surgery.
"All women with implants will face additional surgeries -- no one can tell them when," Gretchen Burns, a nurse consultant at FDA's Center for Devices and Radiological Health, said in an FDA Consumer Update. While a few women have kept their original implants for 20-30 years, "that is not the common experience," she added.
Lerman adds that it's important to get surgery done by an American Board of Plastic Surgery-certified plastic surgeon.
The FDA has more information in its "5 Things to Know About Breast Implants."
