FDA Approves a New Gummy Bear Breast Implant

Allergan’s new silicone breast implant, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Gel Filled Breast Implant, similar to “the Gummy Bear Implant” was approved by the U.S. Food and Drug Administration last Wednesday for breast augmentation in adults 22 and older and in women of all ages who are undergoing a breast reconstruction following cancer.

Photo Credit: MIGUEL MEDINA/AFP/Getty Images

Photo Credit: MIGUEL MEDINA/AFP/Getty Images

Breast implants are silicone gel filled medical devices that are implanted under the breast tissue of women, or under the chest muscle of women seeking breast augmentation or reconstructive surgery following accident or mastectomy. Breast implants generally have a silicone outer shell that is filled with a silicone gel.

The Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant marks the fourth silicone-filled breast implant product available in the United States, and is the latest in a generation of silicone implants that may provide a more natural, firmer shape than other silicone options, because it provides a different type of silicone gel which contains more cross-linking compared to the silicone gel currently used with Allergan’s other breast implant products. The increased cross-linking, which refers to the bonds that link one silicone chain to the next, have produced a silicone gel that’s firmer, and holds up better over time.

plasticbreastaug2Highly cohesive breast implants have been dubbed, “the Gummy Bear Implant” for their consistency when held outside the body and when cut open. Shaped to mimic the slope of the breast, the natural-looking gel implant is filled with a cohesive silicone gel that is not only soft to the touch, but also allows the implant to hold its shape over time with no risk of deflating or leaking.

91075937_a315bce9f1_zAllergan conducted a seven year trial, including 941 women. Side effects of the implant are known to be 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. Unique to this implant, clinical investigators noted cracks in some implants, which is characteristic of the silicone gel.

“The data we reviewed showed a reasonable assurance of safety and effectiveness,” says FDA Center for Devices and Radiological Health (CDRH) Director, Dr. Jeffery Shuren. However, the studies did not compare safety data of the new Natrelle 410 to other currently marketed implants. FDA will continue to monitor the results from post-approval studies, focusing on long-term safety and effectiveness.

As part of the Agency’s conditions of approval, Allergan is required to follow approximately 3,500 women who received the Natrelle 410 implants for an additional five years as part of a continued access study, and Allergan will conduct a ten-year study of more than 2,000 women receiving the Natrelle 410 silicone gel-filled implants to collect information on long-term local complications, such as capsular contracture, reoperation, removal of implant, and implant rupture.

Allergan will also monitor less common potential disease outcomes, such as rheumatoid arthritis, breast and lung cancer, and reproductive complications.

Additionally, FDA has required that Allergan conduct five case control studies to evaluate the possible association between the Natrelle 410 implants, as well as other silicone gel-filled breast implants, and five rare diseases, including rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma.

Implants like the Natrelle 410 have been available in Europe, Canada and Australia since 1995. Last March, FDA approved Sientra’s high-strength silicone gel implants. Dr. Grant Stevens, a prominent plastic surgeon in Marina Del Rey, Calif., coined the term “gummy bear breast implant.” He said he gave the implants their catchy nickname because when cut in half, the implant is stable and retains its shape, much like the chewy, gummy bear candies.

With four options now available, women are asking, “what’s the difference?”

Like other implants, the new Natrelle implants are not lifetime devices. The longer a woman has them, the more likely she’ll develop complications and need more surgery. While some women live with their breast implants for 20-30 years, it is not common. Shuren suggests that any woman considering a breast augmentation should consult an American Board of Plastic Surgery-certified plastic surgeon.

“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,” – Dr. Jeff Shuren, M.D., director of the FDA’s Center for devices and radiological health.

Stevens is an advocate of the “gummy bears” because he said he believes they look and feel more like natural breasts. He insists that “gummy bears” are also safer than other types of implants because they have a lower rupture rate.

Sientra CEO, Hani Zeini and FDA feel that it’s inappropriate for Stevens to compare a medical device to a piece of candy. However, for the cancer survivor, a little humor can go a long way. Learn more about five things the U.S. FDA wants every woman to know about breast implants here.

About Christopher Ford

Christopher Ford is an expert in global medical device manufacturing compliance with over 20 years of experience, specializing in Class II and Class III medical devices and combination products. He is a certified ISO 13485 Lead Auditor, with over 600 audits under his belt, and he works with organizations of all sizes. His approach to compliance requirements balances customer needs with business objectives, while assuring that all regulatory requirements are met.

  • http://www.mightycasey.com/ MightyCasey

    Understanding the risks of a treatment option is critical to making an informed decision. I hope that patients and surgeons are taking the time to walk through this info, particularly on the “it ain’t a lifetime thing” thing.

    • http://www.myfordassociates.com/ Christopher Ford

      Communication is vital, Casey. I also posted an article about the five things women should know about breast implants. It goes into that topic a bit further and includes FDA resources. http://myfordassociates.com/five-things-you-should-know-about-breast-implants/

      • http://www.mightycasey.com/ MightyCasey

        SUPERB post. Just shared it w/#bcsm hashtag. Thanks!!

        • http://www.myfordassociates.com/ Christopher Ford

          Thanks! I’ve got a great infographic I’ll share later, as well.

          • http://www.mightycasey.com/ MightyCasey

            Bring it on – all of it!

  • http://www.myfordassociates.com/ Christopher Ford

    Thanks for commenting, Anni. I agree with you 100%, and I personally don’t see anything about the comparison that minimizes the device or its application. Doctors and manufacturers do this all the time. Communication is of the utmost importance. It’s absolutely critical that a patient understand completely the procedure and device she’s getting involved with, as well as the ramifications. Dr. Stevens’ comparison describes the texture, pliability, and the feel of the device in terms that can be easily understood by the layperson. This is not only an encouraged practice, it’s required in many cases. The specific comparison of a piece of candy to a serious medical device with long term ramifications, on the surface may seem to trivialize the device and the importance of understanding the long term consequences, but I beg to differ.

    The description, Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant doesn’t quite describe the device to a layperson in the same way, “well… it’s like a Gummy Bear – it holds its shape, yet it’s soft, and it doesn’t leak when you cut it open.”

    It’s a well-known fact that humor in medicine is beneficial to healing and recovery, and I give the doc credit for the clever comparison. While he coined the term to describe Sientra’s device, the term was widely accepted, and is already being used to describe all “highly cohesive anatomically shaped silicone gel-filled implants,” including Natrelle.