A Study for Women Having Revision Breast Implant Surgery

About the Study

This study is evaluating whether a surgical support mesh called GalaFLEX LITE™ Scaffold can improve outcomes for women undergoing revision breast implant surgery due to complications such as capsular contracture (hardening of scar tissue around the implant).

The goal is to determine if the mesh helps:

• Keep the implant in place
• Reduce the risk of capsular contracture returning
• Improve overall surgical outcomes

Researchers will also study:

• Patient satisfaction and quality of life
• Short-term safety (such as infection or fluid buildup)
• Longer-term complications, including:
  • Implant loss
  • Wound healing problems
  • Need for additional surgeries
  • Recurrence of capsular contracture

What the Study Involves

Participants are randomly assigned to one of two groups:

• Group 1: Revision surgery using the GalaFLEX LITE™ Scaffold (support mesh)
• Group 2: Standard revision surgery without the mesh

Participants will not be told which group they are in until the study is completed.

All participants will:

• Have revision breast implant surgery
• Complete follow-up visits for up to 2 years
• Fill out surveys about quality of life, comfort, and satisfaction (at about 12 and 24 months)

This study is open to women ages 22–66 who:

• Have breast implants and moderate to severe capsular contracture
• Are planning a revision breast implant surgery
• Plan to replace the implant with a similar size
• Plan to have surgery through the crease under the breast
• Live within about 3 hours of a study site
• Are willing to attend follow-up visits for up to 2 years

You may not be eligible if you:

• Have a BMI below 18 or above 35
• Have implants not approved in the U.S.
• Have a ruptured or leaking implant
• Have had 2 or more prior surgeries for capsular contracture
• Previously had mesh or similar material placed in the breast
• Plan to use another type of surgical mesh or matrix
• Plan additional breast surgeries within the next 2 years
• Have a history of breast cancer or current signs of breast cancer
• Have had radiation to the chest
• Had chemotherapy within the past year
• Have a history of implant-related cancers
• Have autoimmune or connective tissue diseases
• Have serious medical conditions that increase surgical risk
• Take medications that suppress the immune system
• Take blood-thinning medications
• Are currently pregnant, breastfeeding, or have recently given birth
• Plan to become pregnant within the next 2 years
• Had breast infection (mastitis) in the past 6 months
• Currently use nicotine products
• Have had alcohol or substance abuse within the past year
• Plan to use other treatments to manage scar tissue (such as massage therapy)