New Breast Implant Passes Muster at FDA
Posted on February 27, 2013 @ 01:54 pm
Allergan Inc. has won approval from the U.S. Food and Drug Administration (FDA) for its new Natrelle 410 silicone-gel filled breast implant. FDA gave the ok for what the company terms a “highly cohesive anatomically shaped” implant to be used to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
Breast implants are controversial medical products, and approval doesn’t come easy. The passage of Allergan’s pre-market approval application was seven years in the making. FDA evaluated seven years of data from 941 women. According to the FDA, most complications and outcomes found in those years reflect the same issues found in previous breast implant studies: tightening of the area around the implant (capsular contracture); re-operation; implant removal; an uneven appearance (asymmetry); and infection. Investigators did find fissures in the gel of some of the Natrelle implants (a characteristic called “gel fracture”), which is a problem unique to this product.
Shuren assured the public that the data “showed a reasonable assurance of safety and effectiveness,” and that the agency will be looking at post-approval studies to continue to evaluate the long-term safety and effectiveness of the implants.
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. This may be an effort to separate the controversial reputation of breast implants in general; in any case, it prevents the FDA from making any direct comparisons between Natrelle and previous implants. The agency is, however, requiring that Allergan conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease. “Lessons learned from previous post-approval studies on silicone gel-filled breast implants informed the design of post-approval studies for the Natrelle 410,” read a statement from FDA.
According to the requirements, Allergan must:
For Allergan’s part, the company requires surgeons to complete a certification program—which includes instruction on surgical techniques and patient selection—before they are able to offer the Natrelle 410 shaped gel implant option to their patients.
“For many patients, round silicone and saline breast implants are good options. For others, they may not provide the aesthetic outcome they desire,” said Scott L. Spear, M.D., FACS, chairman of the department of plastic surgery at Georgetown University School of Medicine. “As well, patients may have minimal breast tissue remaining after the removal of a tumor or have lost breast volume over the years, so the option of a shaped breast implant designed with an anatomical shape that lasts over time is an important one as it may help these patients obtain the aesthetic look they are seeking.”
“The FDA approval of Natrelle 410 shaped gel implants provides an important new alternative to traditional round implants for women considering breast augmentation, reconstruction or revision surgery," said David E.I. Pyott, Allergan’s chairman of the board, president and CEO. “The Natrelle 410 is the most selected shaped gel implant in markets where the product is already available, such as Europe and Canada. We are pleased that the FDA has recognized the benefits and safety of the Natrelle 410, and has now made the product available as an additional option for women in the United States.”
Allergan makes a range of medical devices in eye care, the neurosciences, medical dermatology and urologics. The company is headquartered in Irvine, Calif.
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