Galaflex Breast Mesh Lawsuits Filed Against Becton Dickinson in Rhode Island

Over the past week, a number of women have filed lawsuits against Galaflex manufacturers, alleging the breast mesh left them with painful and devastating injuries.

Amid rising concerns about the risk of complications associated with the use of surgical mesh during breast reconstruction or augmentation surgery, a number of women are now pursuing GalaFLEX lawsuits in Rhode Island state court, each raising nearly identical allegations that the off-label use of the product left them with painful injuries and the need for additional surgery to remove the mesh from their body.

GalaFLEX is one of a number of surgical mesh products on the market in the United States, which are used to reinforce weakened tissue. However, in recent years, the product has been increasingly used by cosmetic surgeons as an “internal bra” during breast surgery, to improve the breast implant positioning and give added support.

While the breast mesh is designed to dissolve into the body within a year and a half, women have been experiencing painful and disfiguring injuries linked to internal bra failures, raising questions about whether the products were ever safe for use during breast implant surgery.

Although the GalaFLEX was first approved as a scaffold mesh in 2014, the U.S. Food and Drug Administration (FDA) has issued several warnings that the devices are not cleared for breast implant surgery, noting that the agency cannot confirm their safety or effectiveness. No scaffold mesh, or mesh of any kind, has ever been granted that approval as a breast mesh, yet they continue to be widely used by cosmetic surgeons.

Breast Mesh Lawsuits Over GalaFLEX

Complications linked to the widespread use of GalaFLEX mesh as internal bras has led to the emergence of breast mesh lawsuit investigations by lawyers nationwide over the past year, looking into whether the manufacturers provided adequate warnings about the implants’ safety risks.

Over the past few weeks, the first in what is expected to be a series of GalaFLEX breast mesh lawsuits have been brought in Rhode Island state court, where the complaints allege BD maintains its surgical mesh device headquarters. The filings name Becton Dickinson and Co. and several subsidiaries, including Davol Inc., C.R. Bard Inc., Tepha Inc. and Galatea Surgical Inc., as defendants.

Each of the claims involve similar allegations, indicating that the GalaFLEX products were unreasonably dangerous and defectively designed, causing nerve pain, swelling, breast ptosis, seroma and inflammation. Plaintiffs also indicate that the scaffolds do not dissolve properly, leading to additional breast mesh side effects.

Breast Mesh Failure Allegations

According to the lawsuits, Becton Dickinson (BD) has known about the potential risks with using scaffold mesh as an internal bra for years, yet continued to sell their products to be used in such a manner.

FDA officials warned the industry as far back as 2019 that no scaffold mesh, which were all approved through the fast-track 510(k) program, has ever been evaluated and granted approval for use as a breast mesh. Regulators note that “any mesh manufacturer would need to pursue Pre-Market authorization to market a mesh for use in breast surgery.”

Each of the recently filed lawsuits describe similar reports of breast mesh pain, complications and the need for revision surgery experienced by women nationwide. One such complaint was filed by Katherine Jamfar (PDF), of Texas, on April 28. Another was brought by Laura Shrock-Popson (PDF), of Michigan, that same day. The lawsuits present claims such as negligence, strict product liability, negligent infliction of emotional distress, failure to warn, breach of warranty and fraud.

Plaintiffs in these GalaFLEX breast mesh lawsuits and other claims outline a long history of problems involving use of the products in the breast, indicating that did not stop the manufacturers from selling GalaFLEX for off label use.

In November 2023, the FDA sent a letter to BD, noting that the GalaFLEX and Phasix scaffold mesh were being increasingly used in breast surgery. The company has updated the label warnings for the product, yet it continues to sell the mesh directly for breast reconstruction in Europe.

Jamfar alleges she received GalaFLEX during a March 27, 2024 breast augmentation procedure. According to her complaint, she underwent surgery to remove the mesh on April 15, 2025 due to pain, followed by an additional procedure on October 28, 2025 due to ongoing complications.

Shrock-Popson received her GalaFLEX breast mesh in September 2022 during a breast mastopexy procedure. Severe pain also led her to have the implant removed, which her lawsuit indicates left her severely and permanently injured.

The lawsuits allege that defendants sold GalaFLEX for breast surgery despite the lack of FDA clearance or approval for that specific use.

“The conduct of Defendants in continuing to market, promote, sell and distribute the GalaFLEX after obtaining knowledge that the products were failing and not performing as represented and intended, showed a complete indifference to or conscious disregard for the safety of others,  justifying an award in such sum which will serve to deter Defendants and others from similar conduct.”

– Katherine Jamfar v. Davol Inc. et al

Both women seek compensatory and punitive damages.

Breast Mesh Lawsuits

Manufacturers continue to sell these scaffold mesh products as internal bras, which breast mesh injury lawyers anticipate will lead to a growing number of breast mesh lawsuits being filed nationwide in the coming months and years, as sales rise and more implants potentially fail.

Attorneys are now investigating possible lawsuits for women claiming they were never informed that the mesh was not approved for use in breasts before suffering severe injuries and the need for breast mesh explant surgery.

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

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