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PLASTIC SURGERY NEWS, SURGERY NEWS, COSMETIC SURGERY NEWS Current NEWS  |
Experimental breast implant could be safer
By IN-SUNG YOO / The News Journal
02/15/2005
Kristy Kraynak, a personal trainer and amateur bodybuilder, is a svelte fitness advocate with lean body fat - and, until recently, smaller than A-cup breasts.
The Frederick, Md., resident, who had been considering implants for 10 years, finally realized her dream in October, when she entered an investigational trial by Silimed Inc. to receive cohesive gel implants.
Kraynak, 45, is now a 34C and happy with the results.
"They do all the things breast implants are supposed to do," she said. "The way you feel about yourself, I love that I can wear any clothes that I want to, where it used to be very limiting."
Cohesive gel implants, in fact, are silicone gel implants. But unlike their predecessors, the filler in cohesive gel implants has a higher amount of "crosslinker," resulting in a firmer, gummy-bear consistency that does not wrinkle or deflate like saline, nor leak as easily as the more fluid filler of earlier-generation silicone implants.
"If you cut through it, the gel does not leak out," said Dr. Mark Solomon, a plastic surgeon in Bala Cynwyd, Pa., and a spokesman for the American Society of Plastic Surgeons. "It should allay the fears that patients have had about disruption of the shell of the device, causing dispersal of the gel. There's not a whole lot of data to support that that was a significant issue anyway, but this is going one step farther toward putting the whole issue to bed."
When concerns about increased risk for serious health conditions like breast cancer, rheumatoid arthritis and fibromyalgia came to a head in the early '90s, silicone implants were taken off the general market, and saline implants became the only option for women seeking breast augmentation. But despite public perception, saline implants aren't any safer than silicone, said Dr. Donald Kress, the Frederick, Md.-based plastic surgeon who performed Kraynak's implant.
"The saline implant, although at some level of your brain would seem like it would be the safer implant, really isn't," he said. "It has this incredibly high reoperation rate [between 29 percent and 40 percent], so it's not a safer implant."
Several companies are doing clinical trials on cohesive gel implants in the United States, but the devices have been available internationally - including Canada - for as long as eight years, said plastic surgeons.
Still, questions remain as to the safety of silicone implants. A Food and Drug Administration advisory panel could find no strong connection between the use of silicone implants and the occurrence of serious diseases and made a recommendation for approval of the devices in October 2003. But the FDA went against the recommendation - a rare occurrence, said Solomon - and called for further testing to prove long-term safety.
"They're being very cautious at this time," said Solomon.
Kraynak has no misgivings about the implants.
"I really don't believe that you could ever [make them leak]," she said. "You'd have to really injure yourself to rip them, and even if you did rip them, they couldn't leak. So I just don't see a problem with them. Plus I'm in the study, and I will be monitored for at least 10 years."
Clinical trials for cohesive gel implants by manufacturers Inamed and Mentor have been fully enrolled, but trials by Silimed - a Brazilian company with Dallas-based U.S. operations - are still open.
Because the cohesive gel implant has a more stable shape, it works well when implanted above the pectoral muscle, which eases post-operative pain. The firmer shape does necessitate a larger incision to insert the implant, which almost always is made under the crease of the breast.
Cohesive gel implants are not recommended for those seeking especially large implants. Additionally, patients must be in good health and cannot have conditions, such as arthritis, that have previously been tied to silicone implants. Side effects like infection, hematoma and contraction of the pocket holding the implant are still possible with any implant surgery.
Contact In-Sung Yoo at 324-2909 or iyoo@delawareonline.com.
SILICONE IMPLANTS
The Food and Drug Administration imposed a moratorium on silicone gel breast implants in 1992 to the general public until further studies prove their safety. They are still available to women who have had a mastectomy, need a revision or have a chest wall deformity.Cohesive gel implants, which have a firmer consistency, are available to women seeking first-time augmentation through investigational trials. Patients must agree to enroll in a study and be followed for a period of five to 10 years.
The cost for the implants is about $1,800 per pair, about 50 percent more than saline implants. Patients enrolled in the investigational trial must pay for the procedure but receive periodic reimbursement checks that total $650.
