Growing Concerns Over GalaFLEX Breast Mesh Prompt Lawsuits in Rhode Island

Amid growing concerns over the potential complications associated with surgical mesh used in breast reconstruction and augmentation procedures, a number of women have initiated breast mesh lawsuits against Becton Dickinson in Rhode Island state court. These legal claims allege that the off-label use of GalaFLEX breast mesh has resulted in severe injuries, necessitating additional surgeries to remove the mesh.

GalaFLEX Mesh Used in Breast Surgeries 

GalaFLEX is a type of surgical mesh designed to provide internal support during breast surgeries. Initially approved for soft tissue reinforcement, its use as an “internal bra” in breast augmentation and reconstruction has raised significant safety concerns. The mesh is intended to dissolve over time, but many patients report that it fails to do so, leading to painful complications.

Allegations Raised in Breast Mesh Lawsuits

The breast mesh lawsuits filed in Rhode Island state court allege that Becton Dickinson and its subsidiaries marketed GalaFLEX for uses that had not been approved by the U.S. Food and Drug Administration (FDA). Plaintiffs claim that the company failed to adequately inform both patients and healthcare providers about the potential risks associated with the breast mesh devices, including:

• Infection: Many women have reported severe infections following the implantation of the mesh.
• Migration: There are claims that the mesh can shift from its original position, leading to further complications.
• Chronic Pain: Numerous plaintiffs have experienced ongoing pain that has significantly impacted their quality of life.
• Need for Revision Surgery: Many women have had to undergo additional surgeries to remove the mesh due to alleged complications.

A Growing Number of “Internal Bra” Breast Mesh Lawsuits

The legal claims against Becton Dickinson are part of a broader trend of litigation surrounding breast mesh devices that have allegedly caused harm to patients. The lawsuits are currently centralized in Rhode Iscaland’s Superior Court, which aims to streamline the legal process for the claims being filed.

The foundation of these breast mesh lawsuits rests on several legal theories, including:

• Strict Liability: Plaintiffs argue that the mesh was defectively designed and unreasonably dangerous.
• Negligence: Claims suggest that Becton Dickinson failed to exercise reasonable care in the design and marketing of the surgical mesh.
• Failure to Warn: Lawsuits allege that the company did not provide adequate warnings about the potential risks associated with the mesh.

Alleged Breast Mesh Complications Reported by Plaintiffs

Women who have undergone procedures involving GalaFLEX breast mesh have reported a range of serious injuries and complications. These include:

• Nerve Pain: Many plaintiffs describe debilitating nerve pain that has persisted long after surgery.
• Breast Ptosis: Some women have experienced sagging or drooping of the breast tissue, which they attribute to the mesh.
• Seroma Formation: Fluid accumulation around the mesh has been reported, leading to additional discomfort and medical interventions.
• Tissue Necrosis: In severe cases, the mesh has allegedly caused tissue death, necessitating further surgical procedures.

FDA Never Approved Surgical Mesh for Internal Bra Procedures

The FDA issued a labeling update for mesh products in 2023, indicating that no surgical mesh product is approved for use in breast augmentation or reconstruction procedures. “The FDA is aware of increased use of surgical mesh products in breast surgery,” officials stated at that time. “However, the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

A clinical review published in 2021 found that 34% of women who received breast mesh experienced complications within six months, including hematoma, seroma, infection, necrosis, wound dehiscence and delayed wound healing. Of the 154 patients, 13% needed to have the breast mesh surgically removed. A 2024 review of 31 clinical studies involving surgical mesh used in breast reconstruction procedures found that nearly 10% of patients required additional surgery, many for mesh-related complications, and about 3% experienced mesh failure.

A Lack of Regulatory Oversight

The FDA’s oversight of medical devices is crucial in ensuring patient safety. However, the approval process for surgical mesh products has been criticized for being too lenient, allegedly allowing devices to enter the market without rigorous testing. This has led to a growing number of lawsuits as patients seek accountability for their alleged injuries.

As awareness of the potential risks associated with GalaFLEX mesh grows, the ongoing litigation in Rhode Island may set important precedents for future claims against medical device manufacturers. A successful outcome for plaintiffs could lead to increased scrutiny of surgical mesh products and prompt manufacturers to improve safety measures and transparency regarding potential risks.

Are Surgical Mesh Manufacturers Accountable?

The rising number of breast mesh lawsuits against Becton Dickinson highlights the urgent need for accountability in the medical device industry. As more women come forward with legal claims involving alleged mesh injuries, it is essential that manufacturers prioritize patient safety and provide clear information about the potential risks associated with their products. The ongoing legal battles surrounding GalaFLEX mesh serve as a reminder of the importance of informed consent and the need for rigorous testing of medical devices before they reach the market.