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Learn about the recently FDA-approved Sientra 'gummy bear' implants

"Gummy Bear" Sientra Breast Implants Receive FDA Approval


By Samantha Johnson
June 7, 2012

Gummy bear implants March 9, 2012 marked an exciting day in the realm of plastic surgery for surgeons and patients alike when the long-awaited “gummy bear” breast implants became FDA approved. Originally created in the early 1990s, the gummy bears gained a reputation for being a longer-lasting implant that maintains a predictable shape, especially in the vertical position. After three years of clinical trials, these, along with a complete portfolio of silicone implants, received approval for breast augmentation in women at least 22 years old and for breast reconstruction in women of any age.

The “gummy bear” nickname was made popular by Dr. Grant Stevens when he began using it to describe the fact that these implants retain their shape if they are cut, much like the gummy bear candy. But since the term was coined, there has been much confusion as to what exactly the gummy bears refer to. The gummy bear implants are also known as Type 5 highly cohesive or “form-stable” silicone gel implants. Type 5, because they are the fifth generation of silicone implants, and “form stable” cohesive because they are a soft solid that doesn't leak the way old silicone breast implants (which were banned by the the FDA in 1992) would. A cohesive silicone gel breast implant will shift shape as you move, but should not leak if ruptured.

Generations of silicone implants

  • Type 3 – Round silicone implants similar to a standard saline implant which leaks when cut. Available in the U.S since 2006 and currently supplied by all three manufacturers.
  • Type 4 – Known as the Mentor CPG (Contour profile gel) and the Allergan 410 cohesive silicone gel implants, available in the United States since 2006, only come in “teardrop” shape.
  • Type 5 – Supplied by Sientra, also known as “form stable” highly cohesive silicone gel implants, available in the U.S. as of March 9, 2012 in both round and “teardrop” shapes, popularly known as "gummy bear" implants.
  • A less cohesive version of the implants, referred to as Type 4, was already FDA approved and widely available in the U.S. since 2006, and some doctors began to market that version as the “gummy bears.” The newly approved Type 5 implants are the Silimed-brand implants that are supplied by Sientra, a brand new implant manufacturer. Because these silicone gels are more form stable, they are prone to even less leakage than the Type 4 implants supplied by Mentor and Allergan.

    The FDA based its approval for the Silimed-brand implants on three years of clinical data from 1,788 participants, and outcomes reflected those found in previous studies of other breast implants. Complications included tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

    Athough the data derived from the three year study is highly positive, some surgeons are hesitant to pioneer this new product.

    Dr. Stewart Linder, a board-certified plastic and reconstructive surgeon in Beverly Hills, Calif., currently uses 1,000 Allergan Natrelle 410 (Type 4) annually and found rupture rates to be quite low with these implants. “As a result, I personally need to see longer use history with rupture rate before I feel comfortable changing," Dr. Linder told cosmeticsurgery.com. “When a new product comes to market, there has to be a substantial advantage over what I'm currently using. It is great that the Silimed brand is now FDA approved, but it doesn't mean they are 100% safe, and I'd like to see more data before I implement them.”

    In addition to other post-approval conditions, Sientra will continue to follow the 1,788 participants from their pre-market study for an additional 7 years; conduct a 10-year study of 4,782 women receiving the implants to collect data on long-term complications; and conduct five case-control studies that will evaluate the association between Sientra's Silimed silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma.

    "It is great that the Silimed

    brand is now FDA approved, but it doesn't mean they are 100% safe, and I'd like to see more data before I implement them," says Dr. Linder

    Advantages of the new Gummy Bear Implants

  • Teardrop Shape: The “teardrop” shape has been widely available internationally for several years, and American women previously had to leave the country in order to get them. These implants allow for a more smooth transition to the chest at the top of the breast and adds greater fullness below, giving a more natural look. Because of their unique shape, however; they must be inserted more carefully. If the implant is placed incorrectly, it can make the breast look misshapen. There is also a chance that the implant could rotate early in the healing process. These implants also require a longer incision, which translates to a longer scar unless they are inserted through a periareolar or nipple incision.
  • Round Shape: According to Dr. Stevens, the "teardrop" shaped form-stable gummy bear implants are ideal for women who have never had an augmentation, but are not best for women who have had previous breast surgery. The pockets created by the previous implants are generally too large to safely accommodate the unique teardrop shape. The round Sientra form-stable silicone gel breast implants, however, can be safely placed in these patients.
  • Type 5 teardrop implant compared to Type 3
  • Less chance of wrinkling or folding: These Type 5 gummy bears 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 capsular contracture: Studies have shown that capsular contracture is also far less likely in the Type 5 gummy bear implants, with only a 3 percent risk. Capsular contracture can occur when any foreign object is placed in the body. At the time of the initial surgery, a pocket is made for the implant, and 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 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.
  • Type 5 gummy bear implant
  • 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.
  • 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.

    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

    Photo Credits:
    • http://www.dr-adams.com/clinical_trial.htm
    • http://www.dbreath.com/index.cfm/PageID/7249?tag=gummy-bear-implants



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