We have been hearing about their benefits for years as the federal Food and Drug administration methodically mulled over the safety data.
And the wait is finally over. The FDA has approved Allergan's Natrelle 410TM (http://www.natrelle.com) gummy bear breast implant late last week. According to Dr. Tracy Pfeifer, one of the clinical investigators for the FDA-approved study, "This is welcome, game-changing news for many women considering breast augmentation or in need of breast reconstruction. Most silicone breast implants have a silicone gel that feels like honey, while the 410 is more like Jell-O®."
Last March, the FDA first approved a form-stable implant by Sientra. Both of these have been used outside of the US for many, many years. In fact, in most plastic surgery circles outside of the US, this style of implant is their "go to" choice. They can now be used in the US in women at least 22 years old seeking cosmetic breast augmentation and to rebuild breast tissue (reconstruction) in women of any age. A third contender, Mentor's "CPG" implant, will undoubtedly follow soon.
So what took so long?
The FDA takes silicone breast implants very seriously, as their history has been marred in controversy. In fact, there was a moratorium on their use in the US from 1992 to 2006 due to concerns about health asks that first surfaced in the 1980s. Several class action lawsuits followed, and manufacturers had to pay out millions of dollars in damages. But in 1999, the Institute of Medicine concluded that silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, but that's it. In November 2006, the FDA re-approved the sale of two brands of silicone-filled breast implants, Allergan and Mentor. Arguably, the high cohesive gel breast implant is one of, if not the most, studied medical devices in the modern history of medicine.
The gummy bear approval is sweet news for plastic surgeons as well as women eagerly seeking natural looking enhanced breasts. One advantage of these implants is that if they rupture, the silicone gel will stay put. As Patrick Maxwell, MD, FACS, a plastic surgeon in Nashville, TN, explains that this new generation of implants contain gel that won't migrate in your body. As a developer of the 410 Matrix of "Form Stable,' 'Gummy Bear," or "Teardrop" implants, he is a big proponent of this advanced technology. Each patient is unique, and the wide range of choices in the 410 Matrix allows us to personally help a woman custom-select the size and shape of silicone gel implant that offers her the best results. He also invented an innovative 4-D imaging system to design a plan for each patient. He also invented an innovative 4-D imaging system to design a plan for each patient.
‘This is the latest generation of silicone implants that have evolved since the first one was introduced in 1962," says Oren Lerman, MD, a plastic surgeon in New York City. "Women in the U.S. will now have more options for breast augmentation and reconstruction. "
Both Sientra and the newly approved 410 can prevent some of the wrinkling and visible edges seen with the older, traditional implants. "They also can give a more natural shape although they are certainly not ideal for all patients and because they are more firm, some patients prefer the implants currently available," he says.
The new implants will be especially important in breast reconstruction for women with breast cancer after mastectomy where there is no breast tissue to hide the implant. "They can potentially lead to superior results and a more satisfying and natural appearance," he says.
"We are thrilled and excited to have another option available," says Anne Taylor, MD, a plastic surgeon in Columbus, Ohio. "It is thicker and has a firmer feel and may have more applications in reconstructive cases where there is no breast tissue," she says. "The 410 is a wonderful option for those women who need more shape and a firmer platform."
Now that there are more choices for reconstruction and cosmetic augmention, education plays an even bigger role, she says. "Have a good conversation with your surgeon about what is best for you," Taylor says. "They are all safe and effective, but there is no one-size or shape that fits all."
Together with your plastic surgeon, weigh the pros and cons of all of the available implants to make your decision. Find a board certified plastic surgeon on http://www.surgery.org or http://www.plasticsurgery.org
Wendy Lewis is President of Wendy Lewis & Co Ltd, Global Aesthetics Consultancy, author of 11 books and Founder/Editor in Chief of http://www.beautyinthebag.com.
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