Breast Reconstruction Mesh Market Expands Despite Lawsuits Over Synthetic Mesh Failures

Analysts predict greater use of breast reconstruction mesh through 2030 as women pursue lawsuits alleging synthetic mesh caused painful complications and additional surgery.

A new analysis indicates the breast reconstruction mesh market is expected to expand substantially over the next several years, potentially exposing more women to products that are already the subject of lawsuits involving painful and disfiguring complications.

Breast mesh products are implanted to reinforce weakened tissue and provide additional support during breast reconstruction following a mastectomy. Surgeons also use the mesh during breast augmentation, implant revision, breast-lift and corrective procedures, where it may function as an “internal bra” that helps maintain the breast’s position and shape.

However, the FDA has repeatedly warned that surgical mesh products have not been approved for breast reconstruction, augmentation or any other form of breast surgery, even as their use in these procedures has become increasingly common. As a result, the agency has not determined that the products are safe and effective when implanted in the breast.

Breast Mesh Complications & Side Effects

Despite the lack of FDA approval, breast mesh, particularly GalaFLEX, has become increasingly popular in recent years, and has been accompanied by a growing number of breast mesh complications and side effects. These reports include chronic pain, inflammation, infections, nerve damage, breast deformity, tissue damage and reconstruction failure.

Many women have reported to the FDA that the mesh contracted, migrated or failed to dissolve as expected, requiring breast mesh explant surgery, along with months of additional treatments for their injuries.

The growing number of adverse events has prompted a series of GalaFLEX lawsuits to be filed against the manufacturer, alleging the products were defectively designed and sold without adequate warnings about the risk that the mesh may fail to absorb properly, cause a prolonged inflammatory response or leave women with permanent injuries requiring revision surgery.

Breast Reconstruction Mesh Market Expected to Reach $840 Million

Against that backdrop, a market analysis released by The Business Research Company on July 6 predicts continued growth in breast reconstruction mesh use through the end of the decade.

The report estimates the global market will reach $840 million by 2030, reflecting a compound annual growth rate of 6.6%. Analysts attribute the projected increase to advances in biological and absorbable mesh technologies, greater demand for personalized reconstruction outcomes, the expansion of cancer treatment centers and a growing number of surgeons trained to perform reconstructive procedures.

The market includes synthetic and biological mesh products used during implant-based reconstruction, procedures involving a patient’s own tissue, breast implant revision surgery and correction of asymmetry or deformities. The report also points to wider use of pre-pectoral reconstruction, which places the breast implant above the chest muscle, as well as growing demand for minimally invasive procedures and improved cosmetic results.

The analysis highlights the development of bioabsorbable monofilament mesh, which is made from a single strand of material and designed to gradually dissolve after providing temporary tissue support. Manufacturers believe the design may reduce infection risks while still reinforcing tissue during staged breast reconstruction.

As one example, Integra LifeSciences completed enrollment in a multicenter U.S. study of its DuraSorb Monofilament Mesh in 2023. The study is evaluating the product’s safety and effectiveness during breast reconstruction and is intended to support an application for FDA premarket approval.

Breast Mesh Lawsuits

While the report points to growing interest in biological and absorbable mesh products, it does not indicate that synthetic breast mesh is being phased out.

That is notable as medical device manufacturers continue to face breast mesh lawsuits alleging they sold the products for use in breast procedures without FDA approval or adequate long-term safety data.

Plaintiffs also claim they were not sufficiently warned that the mesh could contract, migrate, fail to dissolve or cause complications requiring additional treatment and surgery, including:

• Infections
• Mesh migration or contraction
• Implant or reconstruction failure
• Chronic pain and inflammation
• Tissue damage or breast deformity
• Breast mesh explant or revision surgery

As use of these products expands, breast mesh injury lawyers are evaluating potential claims for women who were not adequately warned about the lack of FDA approval for cosmetic breast procedures and later suffered mesh failure, serious injuries or the need for revision surgery.

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