Anthem Blue Cross Blue Shield has reversed a longstanding policy and will now cover a synthetic surgical mesh used in breast reconstruction surgery, a shift that comes after a Florida breast cancer patient was denied the same coverage less than 24 hours before her scheduled double mastectomy this past July. The insurer updated its medical necessity guidelines in August, officially classifying GalaFLEX and related bioabsorbable scaffolds as medically necessary rather than experimental.
The change followed a yearlong investigation into health insurance denials for breast cancer patients, according to Tampa Bay 28, whose reporter Katie LaGrone tracked the case of Florida patient Beth Clark. Clark was denied coverage for GalaFLEX mesh by Anthem just before her double mastectomy reconstruction surgery in July, a denial that drew local scrutiny after her surgeon publicly challenged it. Clark is now in post-surgery recovery and told the station she learned of Anthem's policy change from her own doctor, adding that while the reversal will not directly affect her own care, she believes it will benefit other breast cancer patients.
How Anthem Explains the Reversal
Anthem previously classified GalaFLEX and similar synthetic mesh devices as investigational and denied coverage on that basis, according to the station's report. The insurer says it regularly reviews medical literature for updated recommendations, and that its policy changed after additional studies and more data became available. Anthem now describes GalaFLEX, GalaFLEX Lite, GalaFLEX 3D, and GalaFLEX 3DR as medically necessary when used for breast reconstruction, per its updated medical policy dated August 13.
Anthem is now one of only two major U.S. health insurers to approve the mesh for breast reconstruction, the same report notes. Cigna set that precedent first, updating its own commercial coverage policy in April 2025 to classify GalaFLEX as medically necessary — a move confirmed in Cigna's April 2025 policy update, roughly 16 months ahead of Anthem's own reversal.
A St. Petersburg Surgeon's Advocacy
Dr. Alicia Billington, a plastic surgeon in St. Petersburg, publicly challenged Anthem's denial of Clark's case and has continued advocating for better coverage for breast cancer patients. She told the station that the back-to-back policy reversals by Cigna and Anthem reflect growing pressure from patients and physicians, and said she wants all patients to have access to the products and procedures they need. Billington is working with the American Society of Plastic Surgeons on a campaign to modernize the Women's Health and Cancer Rights Act so that it explicitly requires coverage for modern reconstructive materials like bioabsorbable mesh — an effort the organization launched in September 2025, according to background from the American Society of Plastic Surgeons.
Surgical mesh is widely used by plastic surgeons performing breast reconstruction, but it remains an off-label, experimental treatment in a regulatory sense: the U.S. Food and Drug Administration has not approved any surgical mesh product specifically for breast reconstruction or augmentation. The agency's November 2023 safety letter to healthcare providers made that gap explicit, noting that Becton Dickinson's GalaFLEX scaffolds — like other surgical meshes — lack dedicated clearance for breast procedures even though surgeons frequently use them off-label. That regulatory ambiguity is what insurers had long cited to label the devices investigational and deny reimbursement.
The Federal Law Behind the Fight
The Women's Health and Cancer Rights Act, signed by President Bill Clinton in 1998, was created to ensure breast cancer patients are covered for needed treatments at every stage of their cancer journey, mandating that health plans covering mastectomies also pay for all stages of reconstruction, symmetry procedures, and complication treatments. But the law predates modern synthetic matrix meshes and does not explicitly detail which device categories must be covered, according to the American College of Surgeons — a gap advocates say insurers have exploited through investigational-product denials. Research published on PubMed found that federal coverage mandates like the 1998 law increased post-mastectomy reconstruction rates by 36 percent within two years in states that previously had no such protections, at a time when national reconstruction rates stood under 18 percent.
Breast reconstruction remains common nationally: board-certified plastic surgeons performed 162,579 such procedures in 2024, making it the third most frequent reconstructive surgery in the country, according to the American Society of Plastic Surgeons. GalaFLEX itself, made by Becton, Dickinson and Company, is a bioabsorbable scaffold built from poly-4-hydroxybutyrate that supports tissue or implants before absorbing over 18 to 24 months as the body's own collagen replaces it, according to Wisner Baum.
Not everyone views the insurer reversals as an unqualified win. Dr. Hooman Noorchashm, a former Becton Dickinson medical director, raised concerns in late 2025 that GalaFLEX lacks dedicated long-term safety data in breast tissue and may produce scar tissue that complicates mammograms for cancer survivors, according to AboutLawsuits.com. That tension — surgeons welcoming expanded access while safety advocates question off-label mesh usage absent long-term clinical trial data — remains unresolved even as coverage expands.
For Clark, the policy change came too late to change her own path through recovery, but she said she hopes it clears the way for other patients facing the same fight. Her case, and the broader investigation into breast cancer insurance denials, now sits alongside Billington's push to update federal law so that future patients do not have to rely on last-minute insurer reversals to get the reconstruction their doctors recommend.
