Seri Surgical Scaffolding use as Breast mesh

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The SERI Surgical Scaffold mesh is unique from other mesh options, as it is engineered by silk, rather than human or other animals. The company touts its product as being strong and effective as a base for the body to regenerate tissue. However, when the product is used in manners not approved by the FDA, many women face life-threatening infections, such as "red breast".  In one lawsuit against the makers of the mesh, also referred to as a sling or screen, the plaintiff contends that she began experiencing chest pain, right arm pain, swelling and immobilization and infections at the surgery site. She also asserted that the pain was so bad, she eventually became "incapacitated in her normal lifestyle". 

In 2015, the FDA sent a letter to Allergan, the makers of SERI Surgical Scaffold, warning the company they were marketing their product for use in a way that was not approved. The letter noted that Allergan's claims that the mesh could be used for various types of breast surgeries constituted “major changes or modifications” to the mesh's intended use - which were not permitted. The FDA letter also described the SERI Surgical Scaffold as misrepresented, because the surgical mesh was not cleared for use in breast revision surgery, muscle flap reinforcement, breast reductions, and mastopexies. Some patients have contended that their doctors were essentially experimenting on them by using the mesh in an off-label capacity.