Nina S. Naidu, MD, FACS, is currently recruiting patients ages 22 or older, in good health, and who have a history of Grade III capsular contracture to participate in a FDA-approved study.
The study is being conducted to evaluate the safety and effectiveness of the Aspen Ultrasound System, a noninvasive device engineered to treat capsular contracture.
Stage I of the study will evaluate and treat 10 women who have received saline breast implants placed into the subglandular (under the breast tissue) space for cosmetic enhancement of the breasts, and who have been diagnosed with Baker Grade III capsular contracture of the breast, which is associated with firmness and distortion of the breast.
Stage II of the study will evaluate an additional 50 women who have received silicone or saline breast implants placed into the subglandular (under the breast tissue) or submuscular (under the muscle) space for cosmetic enhancement of the breasts, and who have been diagnosed with Baker Grade III capsular contracture, explains a media release.
Study subjects will be treated with the ultrasound device twice per week for 5 weeks. At each treatment visit, the affected breast(s) will also be manually massaged and compression dressings will be applied. Follow-up visits will be performed at 6 weeks, 3 months, 6 months, and 1 year following the last treatment. Each visit will last approximately 30 minutes, and the breasts will be examined and photographed at each visit.
Subjects will be asked to complete a questionnaire both prior to treatment and at the final visit to assess their satisfaction with the results of the treatment and rehabilitation protocol. The data compiled from the study will be studied to determine if there are any safety issues with the device or the treatment, and if the protocol was effective in reducing the degree of contracture of the breast, the release continues.
For more information about the study or to determine eligibility for participation, contact Dr Naidu at (212) 452-1230.
[Source: Nina S. Naidu, MD, FACS, Plastic & Reconstructive Surgery]