Phasix Lawsuit

Internal bra surgery is growing increasingly common, as are concerns about the safety risks of using breast mesh in unapproved “off-label” surgeries, especially for breast cancer.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Phasix injury cases in all 50 states. If you experienced breast mesh side effects, infection, tissue damage, reconstruction failure, or surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Internal Bra Mesh Litigation Group or call toll free 24 hours a day at (866) 920-0753.

What is Phasix?

Phasix mesh is a bio-absorbable mesh that is approved for hernia repairs and soft-tissue reconstruction surgeries. It is designed to reinforce soft tissue, where weakness exists, and then slowly dissolve.

How Does It Work?

Phasix Mesh is a knitted monofilament mesh scaffold that uses Poly-4-hydroxybutyrate (P4HB). This is a thermoplastic polyester material is created on an industrial scale using genetically-engineered E. coli bacteria.

P4HB breaks down into 4-hydroxybutyrate, a compound that is naturally found in the human body.

The mesh is designed to trigger an inflammatory response, so that scar-tissue grows on the mesh like a scaffold. The mesh slowly dissolves and is replaced by scar-tissue as the body absorbs P4HB.

FDA Warning: Phasix is NOT Approved for Breast Surgery

In November 2023, the FDA sent a Letter to Health Care Providers, reminding doctors that Phasix Mesh has NOT been approved or evaluated by the FDA for any breast surgeries.

Types of BD Mesh Products

Phasix and GalaFLEX are manufactured by Becton Dickinson (BD). The FDA urged healthcare providers to be aware of updated warnings and precautions for BD mesh products, including:

• Phasix Mesh
• Phasix ST Mesh
• Phasix Plug and Patch
• Phasix ST Mesh with Open Positioning System (OPS)
• Phasix ST Mesh with Echo 2 Positioning System
• GalaFLEX Lite Scaffold
• GalaFLEX Scaffold
• GalaFLEX 3D Scaffold
• GalaFLEX 3DR Scaffold
• GalaFORM Internal Bra

What Should I Do?

The FDA said it is aware of an increasing use of surgical mesh for breast surgery, but the FDA did not recommend routine re-operation or removal of implanted surgical mesh in asymptomatic patients.

“The FDA stresses the importance of clinical evaluations to evaluate the safety, effectiveness, and benefit-risk profile of these products when used for breast surgery. There are no surgical mesh products cleared or approved by the FDA for use in breast surgery, including in augmentation or reconstruction.”

The FDA also urged healthcare providers and patients to use the MedWatch website to report serious problems.

Thousands of Mesh Lawsuits Have Been Filed Nationwide

Phasix mesh was originally developed by Tepha Inc., a company that was acquired by Becton Dickinson (BD) in July 2021. BD is also the parent company of C.R. Bard.

Together, these companies are very familiar with mesh injury lawsuits. Over 24,000 hernia mesh lawsuits and 9,000 vaginal mesh lawsuits have been filed against C.R. Bard in recent years, with many lawsuits ending in settlements or jury verdicts.

Breast Mesh & Phasix Lawsuits

Instead of avoiding internal mesh products with potentially severe side effects and unknown long-term risks, especially in certain patients (such as breast cancer survivors), BD has continued to sell mesh products that are actually shaped like a bra cup, and widely used in “off-label” in breast surgeries like the internal bra.

Despite a lack of FDA approval, BD mesh products are aggressively advertised for breast surgeries by companies like Galatea Surgical and countless plastic surgeons in the U.S.

This may open up a new Phasix Breast Mesh litigation against BD and other companies, with lawyers and innocent victims claiming that they were injured by a product that was not adequately tested for safety.

Legal Claims & Liability Issues

Women who were injured by Phasix, and attorneys who file lawsuits against BD might also argue that the FDA never would have approved Phasix (or other types of BD mesh used in breast surgery, like GalaFLEX) if the agency had been fully informed that these products would be so widely used in breast surgeries like the “internal bra.”

Unknown Safety Risks for Breast Cancer Patients

Breast surgery is not like hernia repairs or other soft-tissue reconstruction, because many patients are actually breast cancer survivors. There are serious safety questions around the use of mesh, which triggers an inflammatory response in the breast tissue. The use of mesh in the breast could also interfere with imaging scans to check for cancer recurrence, which might delay treatment until it is too late.

How Can a Phasix Lawsuit Help?

If you (or a loved one) were injured by Phasix Breast Mesh or the “Internal Bra,” our lawyers may be able to help you file a lawsuit.

Thousands of mesh injury lawsuits have already been filed for other types of products. Every case is unique, but these lawsuits typically seek justice and financial compensation for the victim’s physical and emotional pain and suffering, medical bills, lost income, permanent injuries or disfigurement, decreased quality of life, and other damages.

Do I Have a Phasix Lawsuit?

The Schmidt Firm, PLLC is currently accepting Phasix injury cases in all 50 states. If you were injured by breast mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Internal Bra Mesh Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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