A new type of silicone breast implant, currently available to women whoagree to be part of a clinical study, offers breast augmentation andreconstruction patients more natural looking breasts with a lowcomplication rate, according to a recent study in Plastic andReconstructive Surgery®, the official medical journal of the AmericanSociety of Plastic Surgeons (ASPS). The new gel implants will be thenext type of silicone implant produced by manufacturers if the U.S.Food and Drug Administration (FDA) approves the devices to be marketedand sold in the United States.
"It is an extreme understatement to say our patients are happy withthe more cohesive gel implants," said Mitchell Brown, MD, ASPS memberand study author. "These implants simply look and feel much morenatural than saline implants. My patients are thrilled with theirresults."
The new devices are more cohesive than those currently beingconsidered by the FDA. They have a gummy consistency, which allows themto hold their shape better than saline. According to the study, thegummy consistency decreases the likelihood of rippling and providesgreater safety because, being more solid, the silicone may not escapefrom the shell if it were to rupture. The more cohesive siliconematerial and its textured shell also give the implant a very naturaland proportionate breast shape.
"I think this is a great device," said Walter Erhardt, MD,chair of the ASPS Public Education Committee and surgeon participant inthe cohesive gel implant clinical study. "It's not perfect and there isgoing to be a learning curve for surgeons in terms of educating them onhow to use the more cohesive gel implants. A big criticism of previousimplants has been silent rupture and re-operation rates. In my opinion,this product has a good chance for a greater longevity rate as well asless complications."
According to the study, another benefit of the more cohesivegel implants is the availability of a wide variety of shapes and sizesto more closely match breast shapes and chest dimensions. For example,plastic surgeons can use a patient's breast measurements to customselect an implant specific to each breast.
Beyond the cosmetic advantages of the more cohesive implants, theseimplants have a low complication rate. In the study, only 3.4 percentof the 118 breast augmentation patients experienced complications,including hematoma, capsular contracture, and asymmetry. Nineteenpercent of the 32 breast reconstruction patients experiencedcomplications – most were minor with only one patient requiringre-operation. According to Dr. Brown, this rate of re-operation forbreast reconstruction patients is remarkably low considering theinherent challenges of breast reconstruction. He also noted that withan average follow-up of 21 months (ranging from 16 to 36 months),longer term data will be needed to further substantiate the promisingshort-term results.
"The more cohesive gel implants are going to play a major rolein aesthetic and reconstructive breast surgery if they are approved forsale in North America," said Dr. Brown. "We have already seen theirpotential through studies in Europe. Now, through our own research, weare finding with these implants, re-operation is rare, the complicationrate 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 siliconeimplants for sale in the United States, 13 year after it restrictedaccess to them due to safety concerns. In 1992, the FDA imposed amoratorium on the sale of silicone implants and saline implants havedominated the North American market. In the second half of 2005, afterthe 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 inorder to receive FDA approval. Data regarding this new type of siliconeimplant, the more cohesive silicone implants, has not yet received anFDA panel hearing.
For referrals to ASPS Member Surgeons certified by the AmericanBoard 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 ofboard-certified plastic surgeons in the world. With more than 6,000members, the society is recognized as a leading authority andinformation source on cosmetic and reconstructive plastic surgery. ASPScomprises 94 percent of all board-certified plastic surgeons in theUnited States. Founded in 1931, the society represents physicianscertified by The American Board of Plastic Surgery or The Royal Collegeof Physicians and Surgeons of Canada.
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