Capsular Contracture Study Houston, TX

Benefits for Study Participants 

Patients are eligible for potential benefits, including: 

• Surgery fees waived (excluding anesthesia and facility fees) 
• Study device [provided at no cost] 
• Compensation for follow-up visits when completed as requested 

By joining this study, you not only receive access to an advanced treatment option for capsular contracture, but you also play an important role in helping shape the future of breast implant revision surgery. 

Potential Risks Include: 

• Breast asymmetry (when one breast has a different size, volume, position, or form from the other) 
• Allergic reaction to materials used to manufacture the mesh, including kanamycin and tetracycline, which might lead to serious health issues 
• Allergic reaction to Betadine (a solution used to clean the pocket) in patients with a hypersensitivity to Betadine 
• Breast/nipple sensitivity change (a change in what or how much you feel on/in your breast or nipple) 
• Capsular contracture (when the scar tissue around the implant constricts) 
• Breast deformity (when the breast does not have a normal or typical shape) 
• Erosion (breakdown of the outer layers of the skin) 
• Erythema (abnormal redness of the breast) 
• Explantation: Implant + Scaffold (when the implant and the remaining scaffold need to be surgically removed) 
• Scaffold extrusion (when the scaffold becomes exposed, when the incision doesn’t close correctly) 
• Hematoma (collection of blood in tissues, like a very bad bruise) 
• Imaging artifact(s) (when something is seen in a radiology picture (like an X-ray) that might make the picture difficult to interpret) 
• Impaired wound healing (when one or more issues lead to delayed wound healing) 
• Implant rupture/silicone bleed (when the implant breaks open and/or silicone leaks out) 
• Infection 
• Inflammation (swelling) 
• Implant malposition (the implant not being in the right place / out of place) 
• Necrosis (dead or dying tissue) 
• Pain 
• Ptosis (drooping or sagging of the breast) 
• Skin Rash / Red Breast Syndrome (when the skin is red and inflamed; abnormal redness of the breast that can look like a skin infection) 
• Scaffold/implant malposition (the implant or the scaffold not being in the right place / out of place) 
• Scaffold palpability (being able to feel the scaffold through the skin) 
• Scaffold visibility (being able to see the scaffold through the skin) 
• Seroma (a collection of fluid under the skin, usually near the incision) 
• Soft tissue defect 
• Wound dehiscence (when the surgical wound partially or completely opens) 
• There may be other potential unknown risks associated with the surgical procedure or study device, such as the safety and effectiveness of device usage in proximity to existing or excised cancer, or the impact on breastfeeding. 
• There is a potential unknown impact on the ability to detect breast implant rupture, breast cancer, or other breast diseases. 

What Follow-Up is Required? 

Participants will be followed closely for 24 months to ensure the best possible outcomes. Required visits include: 

• Post-Operative Visit (approx. 90 days post-op) – In-person exam, photos, and review of healing progress 
• 6-Month Phone Visit – Virtual check-in to document healing, side effects, or life changes 
• 12- and 24-Month Follow-Ups – In-person exams, breast imaging, questionnaires, and documentation of results 
• Additional follow-up may be requested if necessary for safety or regulatory purposes.