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New Breast Implant Claims More Natural Look, Fewer Complications but Waits FDA Hearing

Oct. 17, 2005 – A researcher testing a new type of silicon breast implant is enthusiastic with his results. “The implants simply look and feel much more natural than saline implants,” says Mitchell Brown, M.D. “My patients are thrilled with their looks.” Although not yet approved by the FDA, the implants are also being described as having a “low complication rate.”

These augmentation and reconstruction implants are currently only available to women who agree to be part of a clinical study.

The study is published in Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS). The new gel implants will be the next type of silicone implant produced by manufacturers if the U.S. Food and Drug Administration (FDA) approves the devices to be marketed and sold in the United States.

"It is an extreme understatement to say our patients are happy with the more cohesive gel implants," said Mitchell Brown, MD, ASPS member and study author.

The new devices are more cohesive than those currently being considered by the FDA. They have a gummy consistency, which allows them to hold their shape better than saline. According to the study, the gummy consistency decreases the likelihood of rippling and provides greater safety because, being more solid, the silicone may not escape from the shell if it were to rupture. The more cohesive silicone material and its textured shell also give the implant a very natural and proportionate breast shape.

"I think this is a great device," said Walter Erhardt, MD, chair of the ASPS Public Education Committee and surgeon participant in the cohesive gel implant clinical study. "It's not perfect and there is going to be a learning curve for surgeons in terms of educating them on how to use the more cohesive gel implants. A big criticism of previous implants has been silent rupture and re-operation rates. In my opinion, this product has a good chance for a greater longevity rate as well as less complications."

According to the study, another benefit of the more cohesive gel implants is the availability of a wide variety of shapes and sizes to more closely match breast shapes and chest dimensions. For example, plastic surgeons can use a patient's breast measurements to custom select an implant specific to each breast.

Beyond the cosmetic advantages of the more cohesive implants, these implants have a low complication rate. Only 3.4 percent of the 118 breast augmentation patients in the study experienced complications, including hematoma, capsular contracture, and asymmetry.

Nineteen percent of the 32 breast reconstruction patients experienced complications – most were minor with only one patient requiring re-operation. According to Dr. Brown, this rate of re-operation for breast reconstruction patients is remarkably low considering the inherent challenges of breast reconstruction. He also noted that with an average follow-up of 21 months (ranging from 16 to 36 months), longer term data will be needed to further substantiate the promising short-term results.

"The more cohesive gel implants are going to play a major role in aesthetic and reconstructive breast surgery if they are approved for sale in North America," said Dr. Brown. "We have already seen their potential through studies in Europe. Now, through our own research, we are finding with these implants, re-operation is rare, the complication rate is low and patients are extremely pleased with their outcome."

According to the ASPS, more than 264,000 breast augmentations and nearly 63,000 breast reconstructions were performed in 2004.

The FDA is currently considering the reintroduction of silicone implants for sale in the United States, 13 year after it restricted access to them due to safety concerns.

In 1992, the FDA imposed a moratorium on the sale of silicone implants and saline implants have dominated the North American market. In the second half of 2005, after the manufacturers presented data at a panel hearing, the FDA issued "approval with conditions" for the sale of silicone implants, stipulating a number of conditions the manufacturers must satisfy in order to receive FDA approval.

Data regarding this new type of silicone implant, the more cohesive silicone implants, has not yet received an FDA panel hearing.

For referrals to ASPS Member Surgeons certified by the American Board of Plastic Surgery, call 888-4-PLASTIC (475-2784) or visit www.plasticsurgery.org where you can also learn more about cosmetic and reconstructive plastic surgery.

The American Society of Plastic Surgeons is the largest organization of board-certified plastic surgeons in the world. With more than 6,000 members, the society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises 94 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada.

FDA Site on Breast Implants – click here

National Cancer Institute on Breast Cancer – click here

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