Breast Implant Capsular Contracture Research Study
Capsular Contracture is scar tissue that can form in the breasts of women who have undergone breast implant surgery for cosmetic or reconstructive reasons. Sometimes, this tissue can become firm, painful,and even distort the appearance of the breast. Traditionally, this scar tissue has been treated with surgery.
We are currently recruiting patients to evaluate the effectiveness of a non-invasive device to treat capsular contracture. The device, the Aspen™ System, is an ultrasound machine which may soften breast implant capsules when used in conjunction with home exercises and special compression dressings. This machine is not yet FDA-approved in the United States for this use. The study investigator has no financial affiliation with the manufacturer of the device.
To determine if you qualify, you would need to see our study investigator for an initial evaluation and a further discussion of the study. The treatment period will consist of ten treatments performed over the course of 5 weeks (i.e., two visits per week for five weeks). Our study investigator will need to see you again for brief follow-up visits at 6 weeks, 3 months, 6 months, and one year following the last treatment. Each visit will last approximately 30-60 minutes, and your breasts will be examined and photographed at each visit.
Although compensation is not available for this study, subjects will not be charged for any of the visits, whether or not they qualify for the study and complete all visits. Possible benefits of the study include softening of the breast tissues and implant and improved cosmetic appearance of the breasts.
If you would like to be considered a candidate, please fill out the info below and details of how to enroll will be emailed to you.
Note: This study is only open to candidates who live in the Manhattan/NY area.