Breast Mesh Reconstruction Surgery Gaining Popularity Despite Safety Concerns, Lawsuits

Complications and injuries from breast mesh are expected to rise as industry sales grow, with the market projected to surpass $1 billion by 2035.

The use of breast mesh in reconstructive surgery is rapidly expanding, as manufacturers continue to sell the products to surgeons for use as an “internal bra” in women recovering from mastectomy or augmentation procedures. However, there are growing concerns over the safety of the products, which have never been approved by federal regulators for use in breast reconstruction surgery.

A variety of synthetic and biologic breast mesh products—often called mesh scaffolds—have gained popularity in reconstructive and cosmetic surgery over the past few years, involving “off-label” use to reinforce weakened tissue, improve implant positioning, and provide added support after mastectomy.

Products like Phasix, GalaFLEX and Strattice were cleared through the FDA’s 510(k) process for soft-tissue reinforcement, but were later sold to surgeons who have used them for breast reconstruction without agency review or clinical trials confirming their safety for use in breast tissue.

Amid large-scale repurposing efforts by manufacturers, the commercial success of these products continues to grow. 

According to a November Future Market Insights report, the global breast mesh market is currently valued at about $600 million, but it is projected to exceed $1 billion by 2035 as breast reconstruction procedures become more common and device makers expand partnerships. The United States accounts for the majority of global sales, with companies such as Allergan, Johnson & Johnson and Stryker leading the industry.

However, as sales and usage continue to climb, an increasing number of women are reporting painful breast mesh side effects, including infections, mesh migration, implant failure, and the need for revision surgery.

These reports of injuries have prompted many women to begin investigating whether they may be eligible to file a breast mesh lawsuit over the sale of these devices used for breast surgery without FDA approval or adequate safety testing.

Breast Mesh Concerns

The FDA has been raising concerns about problems with breast mesh implants since 2021, when it issued a safety communication warning that it has never approved any of these mesh devices for breast implant procedures, and that all reconstruction or augmentation use is off label.

Recent studies have reinforced the FDA’s concerns, finding that breast mesh use is associated with measurable rates of infection, implant displacement and revision surgeries. The FDA’s own 2021 analysis reported increased risks of infection and implant loss, a greater need for reoperations, and inconsistent performance across different mesh products.

In November 2023, the agency sent letters to healthcare professionals warning them that the 510(k) approval was not meant to include use in the human breast, after Becton, Dickinson and Company (BD) updated the labeling on several of its mesh implants to include new warnings and precautionary language. The FDA instead instructed providers to review the updated labeling carefully, disclose the off-label status to patients, and report any mesh-related injuries or revision surgeries through the MedWatch surveillance system.

Breast Mesh Reconstruction Lawsuits

Despite these warnings, manufacturers have continued to widely sell these products for use during breast surgery, which has now led to a growing number of breast mesh reconstruction complications being reported, as sales continue to rise. 

As a result, breast mesh injury lawyers are now investigating potential lawsuits for women who claim they were never informed that the products were not approved for use in the breast, or of the injuries or side effects that have become so common. 

These investigations allege that manufacturers sold breast mesh products used for reconstruction and augmentation without FDA approval or federally approved long-term safety data. As awareness of the risks spreads, a growing number of injured women are expected to seek legal representation and pursue compensation for complications linked to the implants, including:

• Infections
• Mesh migration
• Implant failure
• Chronic pain
• Revision surgery

Sign up for more health and legal news that could affect you or your family.