Capsular Contracture Study

What Is Capsular Contracture?

Capsular contracture is one of the most common complications following breast implant surgery. It happens when the scar tissue that naturally forms around an implant becomes unusually tight or firm. This can cause the breast to feel hard, look distorted, or become painful.

The condition is graded on a scale from I to IV:

• Grades I–II: Mild cases, often with no visible symptoms.
• Grades III–IV: Moderate to severe cases that can cause pain, firmness, and visible distortion.

Patients with Grade III or IV capsular contracture typically require revision surgery to restore comfort and a natural breast appearance.

Call our office today at (713) 799-9999 or request a consultation using the online form.

Who Qualifies To Participate?

You may be eligible to join the study if you:

• Are a woman between the ages of 22 and 66
• Have capsular contracture (Baker Grade III or IV)
• Plan to receive a new implant with a volume change of no more than ±150cc
• Can commit to required follow-up visits for 24 months

Who Is Not a Candidate?

You may not be eligible to join the study if you have:

• A BMI below 18 or above 35
• Implants larger than 800cc
• A history of breast cancer, chest radiation, or autoimmune disease
• Recent nicotine use, active infections, or systemic illness
• Plans for additional elective breast surgery during the study period

If you’re unsure whether you qualify, our surgeons will review your health history and goals during your consultation to determine eligibility.

Potential Risks

As with any surgery, participation in this study carries some potential risks. These may include, but are not limited to:

• Breast asymmetry (a difference in breast size, shape, position, or contour)
• Allergic reaction to materials used in the mesh, including kanamycin or tetracycline, which in rare cases could cause serious health issues
• Allergic reaction to Betadine, an antiseptic solution, in individuals sensitive to this product
• Changes in breast or nipple sensation (an increase or decrease in how much you feel in these areas)
• Capsular contracture (tightening of the scar tissue around the implant)
• Breast deformity (an abnormal or uneven breast shape)
• Skin erosion (thinning or breakdown of the outer skin layers)
• Erythema (abnormal redness or irritation of the breast skin)
• Explantation: implant and scaffold removal (when both need to be surgically taken out)
• Scaffold extrusion (exposure of the mesh through the incision if the wound doesn’t close properly)
• Hematoma (a collection of blood under the skin, similar to a severe bruise)
• Imaging artifacts (findings on imaging studies—such as X-rays—that make interpretation more difficult)
• Delayed or impaired wound healing (when incisions take longer than expected to heal)
• Implant rupture or silicone leakage (when an implant breaks or leaks)
• Infection
• Inflammation or swelling
• Implant malposition (the implant shifting from its intended placement)
• Tissue necrosis (areas of damaged or dying tissue)
• Pain or tenderness
• Ptosis (drooping or sagging of the breast)
• Skin rash or red breast syndrome (skin redness and inflammation resembling infection)
• Scaffold or implant displacement (movement of the mesh or implant out of proper position)
• Scaffold palpability (being able to feel the mesh under the skin)
• Scaffold visibility (seeing the mesh through the skin surface)
• Seroma (a buildup of clear fluid near the incision)
• Soft tissue defect (an area where the soft tissue is thinner or uneven)
• Wound dehiscence (partial or full reopening of a surgical incision)

There may also be unanticipated risks associated with either the surgical procedure or the study device, such as how it performs near existing or previously removed cancerous tissue or how it might affect breastfeeding. Additionally, the presence of the device may have an unknown impact on imaging, potentially affecting the ability to detect implant rupture, breast cancer, or other breast conditions.