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How to Enroll in a Study on Silicone Breast Implants

Due to concerns about the possible effects of silicone-filled breast implants, the Food & Drug Administration (FDA) has limited silicone breast implants to women who are enrolled in an authorized clinical breast implant study such as the Inamed Medical Corporation (Inamed) Silicone-Filled Breast Implant Adjunct Clinical Study. Dr. Zevon is an approved plastic surgeon investigator in the Inamed Medical breast implant study. If you choose Dr. Zevon to perform your breast implant surgery, you may inquire about enrolling as a patient in the Inamed Medical breast implant study.

You may be eligible for the Inamed Medical breast implant study if you are a candidate for breast reconstruction with breast implants. Some examples of potential candidates include patients with: 1) mastectomy wishing breast reconstruction; 2) severe breast ptosis (sagging) requiring mastopexy; 3) tuberous breasts; 4) certain congenital or acquired deformities of the chest wall, sternum and anterior (front) ribs; 5) previous breast augmentation or breast reconstruction where problems exist such as breast implant rupture, leaking or significant capsular contracture.

After a physical examination, Dr. Zevon will determine if you are a good candidate for inclusion in the breast implant study. If you are eligible, you must also be willing to follow all breast implant study requirements, such as agreeing to all required follow-up visits during the five year breast implant study period, and acceptance of the risks involved.

   New Anatomical Breast Implant

If Dr. Zevon approves of your participation, he can make the necessary arrangements for your enrollment in the Inamed Medical breast implant study. An Institutional Review Board composed of unbiased scientists, health professionals and community members is overseeing the Inamed Medical breast implant study, and protecting the interests of participating patients. The breast implant study will monitor any patient history of rheumatologic disease before and/or after having silicone breast implants. During the Inamed Medical breast implant study, safety of the silicone breast implants will be assessed by documentation of the occurrence of complications, breast implant failure, and other serious potential adverse effects.

Neither the FDA nor Inamed Medical pays for breast implant surgery as part of the study. Study participants must pay for their own surgery. Ongoing breast implant studies such as this one will help determine whether silicone breast implants improve a woman's quality of life and provide scientific information about silicone breast implants.

The Shape of Things to Come New York City Breast Implant News Copyright Dr. Scott J. Zevon, Board Certified Plastic Surgeon of New York City at Central Park Plastic Surgery
The Shape of Things to Come with Plastic Surgery - Dr. Scott Zevon, Board Certified Plastic Surgeon of New York City at Central Park Plastic Surgery

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