From his private practice in Nashville, Dr. Maxwell tells Cosmetic Surgery Times that he is optimistic about the new generation of implants, noting that while today's gel implants are much safer than previous models, new "form-stable gel" styles are the next phase in implant technology and will be a substantial improvement over previous devices. "Going forward, the safety and advantages of silicone gel set a much higher standard than we are accustomed to," Dr. Maxwell says. "They are the gold standard, and they will be for quite some time."
FORM-STABLE VS. STANDARD GEL "The 're-op' rate in FDA [Food and Drug Administration]-approved studies for standard gel implants is 15 percent to 20 percent at two years, predominantly for capsular contracture," says Dr. Maxwell. "But the form-stable gel has about a one percent contracture rate and the re-op rate is approximately 10 percent at two years. The cohesive nature of the gel keeps the device from collapsing and forming shell folds, which is where the breaks in implants usually occur," he explains.Their cohesive nature means that the total failure rate of these implants in test studies performed in Europe has been 0.3 percent over six years, compared to the failure rate for standard gel implants of 8 percent over 10 years."They have a consistency like Jello or soft brie," he says, "and the different heights and degrees of projection available mean they will be more customizable."
CONTROLLING CONTRACTURE According to Dr. Maxwell, the addition of textured surfaces to these form-stable implants has helped to reduce the instances of capsular contracture that have long been associated with breast implant surgery. Now, new possibilities may drive the number of these cases even lower. One such possibility is the application of coatings similar to those used in cardiac stents to prevent the build-up of fatty plaques or scar tissue. When applied directly to an implant or sprayed into the surgical pocket, Dr. Maxwell says that such coatings may help to neutralize contamination from the body's own flora, reduce blood leakage and fluid formation, or minimize the body's inflammatory response — all of which are presumed to play a role in the formation of contractures.
AN IMPLANT-FREE FUTURE? Fat grafting, or lipoinjection, is a procedure commonly used to restore volume in the face and hands, and questions have been posed as to whether a similar approach is suitable, long-term, for breast augmentation.
"Right now centers in Italy and Japan are taking fat obtained in liposuction from other locations," Dr. Maxwell explains. "They wash it, extract the stem cells, and inject the fat into the breast. Not into the parenchyma — into the peripheral fat only." Some sources report up to a one-half cup size enhancement in certain cases.
For now, the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) have cautioned against the use of fat grafting for breast enhancement based on a lack of safety and efficacy data and because the tissue scarring and calcification that may result from the procedure can either mimic or obscure the signs of breast cancer.
As far as using other materials such as various stable polymers to create breast implants, Dr. Maxwell says that implants created from new materials would have to undergo long-term studies unless those materials had already been used safely and effectively. And even then, it would have to be proven that they were more effective than the available gel implants. "Form-stable silicone gel implants set a high standard in terms of safety and aesthetic results. There is nothing on the horizon that can come close to them," he says.
BROADER CLINICAL REACH In Dr. Maxwell's opinion, one of the great advancements in implant technology is the growing ability to successfully address the needs of an entirely new group of women.
"The mature breast is finally being treated in a favorable way," Dr. Maxwell says. "We can enhance or recreate what's been lost. With the new devices we can better control shape, shorten scars and reduce down time and morbidity. Refinements in surgical technique and adjunctive measures will add to this already optimistic picture."
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