December 4, 2006 — Silicone gel breast implants are now available at the Center for Cosmetic Surgery in the metropolitan area. Dr. Andrew J. Wolfe and Dr. Steven D. Vath, both certified by the American Board of Plastic Surgery, applaud the Food and Drug Administration’s recent decision to approve the devices and are pleased to offer them as options for patients seeking breast enlargement in the areas.
In 1992, the FDA banned the use of silicone-filled breast implants in the United States for all but breast reconstruction and other select patients. The FDA then began an extensive review of silicone gel breast implants, placing them among the most widely studied of all medical devices. In the fourteen years since the ban, the FDA reviewed data from clinical trials following women up to four years, studied information from independent scientific bodies, and heard from outside experts who gathered and evaluated public comment.
Following the extensive study, the FDA approved silicone gel implants for use in the U.S. because they are safe. “Patients who have been eligible to receive silicone implants in recent years approve them as well,’ said Dr. Vath, “reporting they have a natural look and feel.”
The silicone gel used in the newly-approved implants has several advantages, according to Dr. Wolfe. The cohesive silicone material is soft and supple, enabling the surgeons to give their patients the natural feel they are seeking. There are several types of cohesive silicone implants available, including the form-stable silicone or “gummy bear” implants. The attributes of the silicone gel also give women another reason to feel comfortable. “If silicone gel implants rupture,” explained Dr. Wolfe, “the semi-solid material is maintained within the patient’s natural implant capsule and does not leak throughout the body.”
Dr. Wolfe and Dr. Vath are enthusiastic about the new option available to patients. “Naturally, no one solution fits everyone,” said Dr. Vath, “and we look forward to consulting with our patients about their choices.”