Beth Clark, 48, was diagnosed with invasive ductal carcinoma three months ago and planned to undergo a full double bilateral mastectomy with reconstruction. Less than 24 hours before her reconstruction surgery, Anthem Blue Cross and Blue Shield denied coverage for the procedure. According to the denial letter, the surgery involving a surgical mesh called GalaFlex is still considered investigational and there is no or not enough proof it improves health. GalaFlex is a synthetic surgical mesh that is popular among plastic surgeons and approved by the FDA for some uses in the body, but it is not approved for breast reconstruction and is still considered an off-label, investigational, and experimental treatment. In a 2023 letter to health care providers, the FDA stated its efficacy and safety for breast cancer patients have not been determined.
Dr. Alicia Billington, Clark's plastic surgeon, uses GalaFlex mesh on most of her breast reconstruction patients and believes the product gives patients the least amount of complications compared to other options. Despite the insurer's denial, Clark received her reconstruction surgery with the GalaFlex mesh a little more than a week ago after Billington found a mechanism to make it happen. An Anthem spokesperson said the company regularly reviews medical coverage policies to ensure they are based on medical evidence and aligned with the latest treatment standards, adding that without FDA approval, the mesh does not currently meet the standards required for coverage by their medical policy. Clark and Billington are still fighting the denial.