"Gummy Bear" Sientra Implants Receive FDA Approval

Samantha Johnson

by Samantha Johnson | June 7, 2012 @ 02:00PM

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Sientra Silimed It was an exciting day for plastic surgeons and women alike when an implant named after the tasty little candies we all know as gummy bears received FDA approval.

It happened on March 9, 2012. A brand-new implant manufacturer known as Sientra received approval for not only the long-awaited gummy bear implants, but also their entire line of Silimed-brand silicone breast implants.

More technically referred to as form stable cohesive silicone gel implants, the gummy bears initially made their debut in the early 1990s and became coveted for their ability to maintain a predictable shape. The FDA banned all silicone implants in 1992 because of some health concerns, but silicone was back on the market after extensive testing in 2006. Every year since then, breast augmentation has remained the most popular cosmetic surgery procedure to date, with 307,000 procedures performed in 2011, according to the American Society of Plastic Surgeons.

The gummy bear hype began when Dr. Grant Stevens, who was one of the few surgeons chosen to work with these implants during their clinical trials, tried explaining them to his clients. He used to equate their leak-proof structure to that of JELL-O, but once he saw a child in his office snacking on some gummy bears, that name stuck. Unlike saline or the standard (Type 3) silicone implants, the gummy bear implants do not leak when cut or punctured.

Another version of silicone implants is often mistakenly referred to as the gummy bears. These Type 4 implants have been on the market in the U.S. since 2006 and have been widely available, but they are not as strong or “form stable” as the Type 5 implants manufactured by Sientra.

The new-and-improved Type 5 gummy bear implants underwent three years of clinical trials prior to their approval in March, and the data showed that complications and outcomes from these implants were no different than side effects of current generation implants. Some outcomes included tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

However, the data also showed some clear advantages:

Sientra round and shaped implantsMore natural breast shape: Included in their implant arsenal is Sientra's “teardrop” or anatomical gummy bear implant. These implants more closely mirror an actual breast shape: thin on the top by the chest wall, and thicker toward the bottom where fullness is desired. These implants are recommended for first-time breast implant patients, breast reconstruction and breast lift patients. The round version of these implants is more suited for women who wish to replace their previous implants.

Great for replacing previous implants: The round version of the Sientra gummy bears is the only round highly cohesive implant currently on the market. Since breast implants are not lifetime devices, they sometimes need to be replaced. The pocket that develops around the implant after initial surgery generally cannot contain a teardrop shaped implant because of its unique shape. The round implants work well for women who have had previous implants because they easily fit into the pocket without complications.

Lower capsular contracture rate: Capsular contracture can occur when any foreign object is placed in the body. During the healing process, the body uses its own tissue to form a lining, or capsule around the foreign object.  Under normal conditions, the pocket of tissue that surrounds the implant remains open, thus allowing the implant to look and feel natural. However, in some people, the capsule will tighten and squeeze the implant making the implant feel hard and look distorted. Studies have shown that capsular contracture is far less likely with Type 5 gummy bear implants, with only a three percent risk – another reason why women might consider replacing their current implants with gummy bears.

Less chance of wrinkling or folding: The Type 5s have significant advantages when compared to the standard breast implants, or Type 3s, which leak when cut. If you place a Type 3 implant on a flat surface, it is smooth, but once it is held upright, there is a rippling or folding effect that can sometimes show through the skin. Since gummy bear implants are thicker and stronger, this kind of wrinkling is far less likely.

Less chance of implant rupture: Since the gummy bear implants do not leak, there is also less of a chance of implant rupture. In the unlikely event that the implant did rupture, the implant material would remain intact and well confined within the pocket. Concerns have risen about how anyone would even know their implant had ruptured, which is why breast implant patients are encouraged to get regular MRIs. The FDA has recently patented a solution for this that will actually change the color of the patient's urine if the implant leaks, and may squelch the need for regular MRIs in the future.

In addition to other post-approval conditions, Sientra will:

  • continue to follow the 1,788 clinical trial participants in their pre-market study for an additional 7 years;
  • conduct a 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer; and
  • conduct five case-control studies that will evaluate the association between Sientra's silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

If you are considering breast augmentation, it is best to find a physician near you and book a consultation. A board-certified plastic surgeon can answer your questions and give you guidance based on your unique needs.

Photo Credit: www.sientra.com

Sources: 

  • Merrill, Shelli; plasticsurgerypractice.com; "W. Grant Stevens, MD, FACS, on Cohesive Gel Breast Implants," Sept. 2009
  • http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295437.htm
  • W. Grant Stevens, MD, FACS; http://aes.sagepub.com/content/30/5/693, "A Prospective Study of 708 Form-Stable Silicone Gel Breast Implants," Jul. 2010
  • http://abcnews.go.com/Health/gummy-bear-breast-implants-future-breast-augmentation-surgery/story?id=16370362#.T71RxnlYtLp

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