GalaFlex Mesh Lawsuit

GalaFlex is a resorbable surgical mesh implant made from poly-4-hydroxybutyrate (P4HB) designed to provide soft tissue support in alloplastic breast reconstruction, breast lifts (mastopexy), and body contouring procedures.

BD (Becton, Dickinson and Company) manufactures several BD mesh products including GalaFlex Scaffold, GalaFlex 3D Scaffold, GalaFlex 3DR Scaffold, and GalaFlex Lite Scaffold.

These devices were marketed to plastic surgeons and other specialists as an “internal bra” solution to provide additional support for breast implants, support breast tissue, and prevent sagging after surgery.

The mesh is composed of high-strength P4HB monofilament fibers knitted into a macroporous scaffold.

FDA Clearance and Off-Label Use

GalaFlex received FDA 510(k) clearance in 2014 for repair and reinforcement of soft tissue where weakness exists, but was not approved by the FDA for breast surgery.

Despite this limited clearance, surgeons increasingly adopted GalaFlex mesh for off-label use in breast procedures.

This regulatory gap manifested in several ways:

• FDA 510(k) clearance granted May 21, 2014 (K140533) authorized GalaFlex only for general soft tissue repair and reinforcement applications
• Surgeons began using the device off-label in breast reconstruction and cosmetic surgery procedures like breast augmentation and mastopexy as an “internal bra” technique to improve aesthetic outcomes without specific FDA approval for these applications
• November 2023 FDA safety communication emphasized that no surgical mesh products have been determined safe or effective for breast surgery

Following the FDA’s November 9, 2023 letter to health care providers, BD updated labeling for all GalaFlex products in 2024.

The revised warnings and precautions sections now explicitly state that “the safety and effectiveness of surgical mesh in breast surgery has not been determined by the FDA.”

This labeling change acknowledges the widespread off-label use while clarifying the absence of FDA authorization for breast mesh surgery applications.

If you received GalaFlex mesh during a breast procedure and experienced complications from this off-label use, you may have grounds to pursue legal action against the manufacturer.

Contact TruLaw using the chat on this page to receive an instant case evaluation and learn if you qualify to file a GalaFlex Mesh lawsuit today.

Patients have reported a range of adverse events after receiving GalaFlex mesh implants, leading to revision surgeries, permanent injuries, and substantial medical expenses.

Both short-term and long-term complications linked to GalaFlex have been documented in clinical studies and adverse event reports submitted to the FDA.

The Food and Drug Administration (FDA) warnings in the 2023 safety communication specifically highlighted concerns about surgical mesh use in breast surgery, noting the lack of safety determinations for these applications.

Former BD Medical Director Dr. Hooman Noorchashm, a known safety advocate, raised alarms about unreported adverse events and breast cancer recurrence data.

Types of Complications Reported

Adverse events from GalaFlex mesh have emerged at various timeframes following implantation, ranging from immediate post-operative problems to issues developing months or years later.

Patients have experienced the following adverse events at various time frames after implantation:

• Infections, seromas (fluid accumulation), and delayed wound healing occurring within weeks to months after surgery, often requiring antibiotic treatment or surgical drainage
• Internal bra complications including chronic inflammation, chronic pain, mesh migration, device failure, and palpable or visible mesh edges requiring revision surgery to remove or reposition the implant
• Scar tissue formation, tissue necrosis, skin breakdown, allergic reactions, and breast cancer recurrence concerns raised by former company medical director regarding unreported safety data

Medical records show patients experiencing complications from synthetic mesh use, including implant loss, often require multiple corrective procedures.

Revision surgeries to remove failed GalaFlex mesh from the chest wall can result in additional scarring, breast deformity, and permanent disfigurement.

If you suffered infections, chronic pain, mesh migration, tissue necrosis, or required revision surgeries after receiving GalaFlex mesh, you may be entitled to compensation for your injuries and medical expenses.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a Breast Mesh claim today.

Patients are filing claims alleging the manufacturer failed to warn about serious risks and promoted the device for off-label uses without adequate safety testing.

Lawsuits involving defective medical devices are in early stages with attorneys evaluating cases nationwide.

Similar surgical mesh litigation, including cases involving acellular dermal matrix products, has resulted in settlements and verdicts compensating injured patients for medical expenses, lost wages, pain and suffering, and other damages.

Former BD Medical Director raised concerns about withheld adverse event reports and breast cancer recurrence data.

Lawsuit Allegations Against Manufacturers

Plaintiffs allege BD failed to warn about risks of internal bra mesh implants despite mounting evidence of complications.

Plaintiffs have brought forward the following allegations:

• Failure to warn healthcare providers and patients about risks of using GalaFlex mesh in breast surgery despite documented complications
• Off-label marketing of the internal bra device for breast procedures without proper FDA authorization or clinical trials establishing safety
• Withholding adverse event reports and breast cancer recurrence data from FDA, as alleged by former BD Medical Director Dr. Hooman Noorchashm who raised concerns about 400-500 reports before termination

If you were harmed by GalaFlex mesh that was marketed for off-label use without proper FDA authorization or adequate safety warnings, you may be eligible to seek compensation from the manufacturer.

Contact TruLaw using the chat on this page to receive an instant case evaluation and find out if you qualify to file a GalaFlex lawsuit today.

Who Qualifies for a GalaFlex Mesh Claim

Patients who received GalaFlex mesh implants during certain procedures may qualify.

You may qualify to file a claim if any of the following apply:

• Patients who received GalaFlex mesh during breast reconstruction, breast lift, augmentation, or body contouring
• Individuals who suffered severe injuries including infections, chronic pain, device failure, mesh migration, tissue necrosis, or other serious complications
• Those who underwent mesh removal to address failed devices or experienced permanent injuries

Statutes of limitations vary by state, typically 1-3 years from injury discovery.

If you meet any of the qualifications listed above and suffered harm from GalaFlex mesh implants, time may be limited to protect your legal rights due to statutes of limitations.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine if you qualify to file a Breast Mesh litigation claim today.

Our Breast Mesh attorney at TruLaw is dedicated to supporting clients through the process of filing a Breast Mesh lawsuit.

With extensive experience in product liability cases, Jessica Paluch-Hoerman and our partner law firms work with litigation leaders and medical experts to prove how defective breast mesh implants caused you harm.

TruLaw focuses on securing compensation for medical expenses, revision surgeries, pain and suffering, lost income, and other damages resulting from your breast mesh injuries.

We understand the physical and emotional toll that Breast Mesh complications, including reconstructive breast surgery failures, have on your life and provide the personalized guidance you need when seeking justice.

Meet the Lead Breast Mesh Attorney at TruLaw

Meet our lead Breast Mesh attorney:

• Jessica Paluch-Hoerman: As founder and managing attorney of TruLaw, Jessica brings her experience in product liability and personal injury to her client-centered approach by prioritizing open communication and personalized attention with her clients. Through TruLaw and partner law firms, Jessica has helped collect over $3 billion on behalf of injured individuals across all 50 states through verdicts and negotiated settlements.

How much does hiring a Breast Mesh lawyer from TruLaw cost?

At TruLaw, we believe financial concerns should never stand in the way of justice.

That’s why we operate on a contingency fee basis – with this approach, you only pay legal fees after you’ve been awarded compensation for your injuries.

If you or a loved one experienced chronic pain, infection, mesh migration, capsular contracture, implant failure, or other complications from breast mesh implants, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a Breast Mesh lawsuit today.

Breast mesh lawsuits, also known as internal bra lawsuits, are being filed by women across the country who suffered serious complications from surgical mesh used in breast reconstruction surgery and augmentation procedures.

TruLaw is currently accepting clients for the Breast Mesh lawsuit.

A few reasons to choose TruLaw for your Breast Mesh lawsuit include:

• If We Don’t Win, You Don’t Pay: The Breast Mesh lawyers at TruLaw and our partner firms operate on a contingency fee basis, meaning we only get paid if you win.
• Expertise: We have decades of experience handling product liability cases similar to the Breast Mesh lawsuit.
• Successful Track Record: TruLaw and our partner law firms have helped our clients recover billions of dollars in compensation through verdicts and negotiated settlements.

If you or a loved one suffered mesh migration, chronic pain, infection, or other complications after receiving breast mesh implants, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation that can determine if you qualify for the Breast Mesh lawsuit today.