Integra LifeSciences (IART) Issues Statement Regarding FDA Safety Communication on Acellular Dermal Matrix Products Used in Implant-Based Breast Reconstruction
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Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company and manufacturer of SurgiMend Collagen Matrix, today issued the following statement regarding the U.S. FDA safety communication on the differences in complication rates between acellular dermal matrix (ADM) products used in implant-based breast reconstruction.
“Integra LifeSciences supports the efforts of the U.S. FDA to protect women’s health, including its recent safety communication on ADM products used in implant-based breast reconstruction.
SurgiMend Collagen Matrix is currently cleared by the FDA for use in certain types of surgeries to reinforce tissue where weakness exists, such as plastic and reconstructive surgery, and hernia repair. Neither SurgiMend nor any other ADM (human or xenograft) is currently approved for use in breast reconstruction in the United States. It is important for patients to discuss the use of medical technologies, including SurgiMend, with their healthcare providers.
Integra is committed to delivering safe and effective medical technologies and products to our customers and their patients, including securing clearance or approval for a product indicated for breast reconstruction. We work to consistently meet or exceed industry and global regulatory standards to provide quality products and technologies designed to meet the needs of our customers and their patients.
We applaud the ongoing work of the various surgeon associations and patient advocacy groups in reinforcing the importance of quality patient care and promoting education, advocacy, and public awareness of various healthcare issues. Integra continues to collaborate with the clinical community to pursue solutions to advance women’s health.”
About the SurgiMend Collagen MatrixSurgiMend Collagen Matrix is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for:
- Plastic and reconstructive surgery.
- Muscle flap reinforcement.
- Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernia.
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