Who can be held liable for injuries caused by breast mesh?

Breast mesh lawsuits may name one or more defendants. Most product liability actions are filed against the manufacturer of the product, and current litigation is against Becton, Dickinson and Company and its GalaFLEX and Phasix product lines.

Plaintiffs commonly allege that manufacturers:

• Designed an unreasonably dangerous product
• Failed to warn about known or reasonably knowable risks
• Marketed the product for uses lacking sufficient clinical evidence
• Failed to adequately test the product before surgical use

A product's marketing or distribution chain can also bring distributors and suppliers into litigation. Some cases include separate claims against physicians for informed consent failures, not disclosing off-label use, surgical negligence, or untimely responses to complications. Where infection control, credentialing, or staff negligence is alleged, hospitals and surgical centers may also be named.

Many breast mesh cases involve off-label use, where the mesh was used for a purpose not included in its FDA-authorized labeling. That fact alone doesn't establish negligence on the part of a healthcare provider or liability for a manufacturer. In 2023, the FDA said that updated labeling was required but nothing beyond that. That may still carry some weight as evidence in some cases.

Identifying the mesh manufacturer is one of the earlier steps in determining who may be held accountable, and that detail can usually be tracked down through operative reports, implant stickers, or device identification labels in your medical chart.

Atraxia Law can assist you with your breast mesh claim

Our team has over 35 years of experience in defective medical device litigation and can review your records to determine which parties may be responsible for your complications. Viable breast mesh claims are connected with a qualified attorney to pursue deserved compensation. Contact Atraxia Law today to get started.