Sientra’s breast implant approved by the U.S. FDA

By Dr. Ananya Mandal, MDMar 12 2012

The U.S. Food and Drug Administration (FDA) has conditionally approved a new silicone-gel breast implant. This is the third breast implant approval.

The implant, manufactured by Santa Barbara-based Sientra, can be used for breast tissue reconstruction for women of any age and for breast augmentation in women 22 or older. The approval resulted from three years of clinical studies on almost 1,800 patients. Tightening of the area around the implant, re-operation, implant removal, uneven appearance and infection were some of the complications experienced during the study. Sientra is required to continue studies on the implant's long-term safety, effectiveness and risks of rare diseases under the approval.

The company said it will offer implants in multiple shapes and sizes, in addition to the round implants currently sold by Allergan Inc. and Johnson & Johnson's Mentor unit. The privately held company, founded in 2007, specializes in plastic surgery implants, including those for the face, legs and buttocks. “Sientra has successfully broken the existing duopoly in the U.S. by offering surgeons and patients a new choice,” said CEO Hani Zeini, in a statement. Allergan Inc. is based in Irvine, Calif., and Mentor, a unit of Johnson & Johnson, is based in Santa Barbara.

More than one in five women who get implants for breast enhancement will need to have them replaced within five years, accord to an FDA analysis of company data released last summer. Despite that relatively high failure rate, FDA regulators concluded that the silicone-gel implants are basically safe as long as women understand they come with complications. Similar problems are connected with saline-filled versions of breast implants, which are less popular.

“Data on these and other approved silicone-gel filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” Dr. William Maisel, deputy director for science in the FDA's Center for Devices and Radiological Health, said in an agency news release.

Dr. John Oeltjen, an assistant professor of plastic surgery at the University of Miami School of Medicine, thinks the FDA decision is a good one. “The implant from Sientra is like the implants from other companies already marketing implants,” he said. “So that's not out of line.”

“In general, there are no problems with silicon gel implants,” he said. The advantage of silicon gel over saline implants is that the silicon has a more natural look and feel, he added, while saline implants can wrinkle, which can show through the skin. However, Oeltjen said he would like to see the FDA also allow marketing of contoured implants, which are not round, but shaped more like a natural breast.

Dr. Jeffrey C. Salomon, a clinical professor of plastic surgery at Yale University School of Medicine, noted, “Sientra is a brand that has been used in Brazil for an extended length of time, and I doubt that there were concerns about cancer, otherwise the FDA would have not approved them.” He added, “While the next generation of breast implants is the so-called form stable variety, those implants have not been released in the U.S. despite being used throughout the world for a few years.” “The form stable implant does not develop capsular contracture, which is a response by the body to a foreign object and can result in pain and discomfort as the implant is squeezed by fibers created by the immune system,” he added. “And that is really the category of breast implant surgeons are anticipating the release of.”

Dr. Alan Matarasso, a plastic surgeon at Lenox Hill Hospital and Manhattan Eye, Ear and Throat Institute in New York City, said, “This [the FDA decision] is exciting information for patients because it offers another choice for women undergoing breast cancer reconstruction or cosmetic breast augmentation.”

Common complications with breast implants include: hardening of the area around the implant; the need for additional surgeries; and implant removal. Other frequent problems include implant rupture, wrinkling, breast asymmetry, scarring, pain and infection, the FDA said. The FDA recommends that women who get silicone implants: follow-up regularly with their doctor, which includes occasional MRIs to detect potential ruptures; pay attention to any changes and notify their health-care provider if they notice any unusual symptoms such as pain, asymmetry or swelling; and educate themselves on the signs and symptoms of complications.

“It's important to remember that breast implants are not lifetime devices,” Maisel said. “Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”