Known as the form-stable cohesive gel implant, the device is gaining popularity in foreign countries, where it has been used for the past 10 years, and with patients involved in clinical trials around the United States. Yet debate may follow this gel's introduction, as well.
"The cohesive gel implants are pre-filled, causing you to force them in, possibly causing the gel to be fractured. Because of this you need a very sizeable incision, from 5 to 6 centimeters long, for insertion," said Richard A. Mladick, M.D., at the annual meeting of the American Society of Plastic Surgeons (ASPS) here."I don't like this approach for the very reason that I'm not a fan of silicone gel."
Established vs. novel
In a panel presentation, Dr. Mladick joined William P. Adams Jr., M.D.; Claudio L. De Lorenzi, M.D.; and Richard Sadove, M.D., to discuss current alternatives in breast augmentation. Dr. Adams is currently enrolling patients in a clinical trial to evaluate the cohesive gel implant, while Drs. De Lorenzi and Sadove offered their experience with the device's use in Canada and Tel Aviv, Israel, respectively.
"I have inserted a large number of the cohesive gel implants throughout the last five years due to patient-driven demand," says Dr. De Lorenzi, medical director, the De Lorenzi Clinic, Kitchener, Ontario.
"In terms of safety, there have been more studies on silicone gel than regarding heart valves. (Cohesive gel) implants are not showing safety concerns since I began using them in 2000."
When asked, a sizeable number of audience members at the panel presentation did admit they would switch to the cohesive gel implant upon its approval in the United States due to the enhanced "natural feel" the devices offer the patient. Yet the reason why patients would readily exchange saline for cohesive gel is incorrect saline implant technique, according to Dr. Mladick.
"The reason cohesive gel seems appealing is because many are not inserting saline implants correctly,"says Dr. Mladick, director, the Mladick Center for Cosmetic Plastic Surgery, Virginia Beach, Va..
"I only insert saline implants under the muscle using the 'no-touch' technique. This ensures a softer breast with no capsular contracture. If you fill it with the correct amount, which would be toward the higher end if it's an implant that is plus or minus 25 cc or 50 cc, the patient gets a very nice result. Also, saline implants cause less interference with mammograms than gel implants."
While saline is known as the safer alternative to silicone, the cohesive gel's "high strength" is leading to supportive clinical evidence that it is as safe as saline implants. The device's gel is thick due to the number of cross-linking silicone strands. Because of this, even when the device is cut, liquid and oil do not leak out, leaving the implant in its original shape.
German studies suggest that the environment necessary to cause leakage could not be created in a living human.
"Cohesive gel's complications are very much the same as saline and traditional silicone," Dr. De Lorenzi says.
"The exception is that cohesive gel does not cause rippling or wrinkling to the extent the other types do."
Patients prefer cohesive gel implants due to their "non-detectable" presence, and demand is eliminating the alternatives within his practice, according to Dr. De Lorenzi.