Breast Mesh Lawsuits

Breast mesh implants, commonly referred to as “internal bra” devices, are surgical products used during breast reconstruction and augmentation procedures to provide structural support.

Surgeons increasingly use these materials as scaffolding or support systems for tissue expanders and implants in implant based breast reconstruction.

With approximately 105,000 breast reconstruction procedures performed annually following breast cancer and nearly 300,000 augmentation surgeries, many women now receive mesh products during their breast surgeries.

These devices function as internal scaffolding designed to lift and support breast tissue and implants during healing to preserve aesthetic outcomes.

What Are Breast Mesh Internal Bra Implants?

Internal bra mesh consists of synthetic or biologic scaffolding materials placed during breast surgery to lift and support tissue.

These surgical mesh products serve as temporary structural reinforcement while the body develops new supporting tissue.

Surgeons apply breast mesh products in the following two primary contexts:

• Breast reconstruction surgery after mastectomy: Surgeons place mesh along the chest wall to support tissue expanders and implants following cancer treatment in alloplastic breast reconstruction
• Cosmetic breast augmentation and breast lift procedures: Mesh provides internal support for implant placement and tissue repositioning
• Material composition: Products include synthetic or biologic mesh including P4HB (poly-4-hydroxybutyrate) polymer scaffolds and acellular dermal matrices made from processed human or animal tissue

These mesh products provide temporary structural support during the healing process.

Manufacturers claim the scaffolding materials encourage the body’s natural collagen production to create permanent tissue reinforcement.

As new collagen develops around the mesh, the synthetic or biologic material is designed to gradually absorb or integrate into surrounding tissue, theoretically creating long-term structural support for breast tissue and implants.

If you received GalaFLEX, Phasix, AlloMax, or FlexHD mesh during breast reconstruction or augmentation and experienced serious complications, you may have grounds for legal action.

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

FDA Clearance Status and Off-Label Use Concerns

Mesh products used in breast surgery received Food and Drug Administration clearance for soft tissue repair, not specific breast approval.

The FDA issued a letter to healthcare providers in November 2023 clarifying this regarding BD mesh products.

The regulatory landscape presents several key concerns:

• Limited Food and Drug Administration (FDA) clearance: Products like GalaFLEX and Phasix received 510(k) clearance only for soft tissue repair in areas such as hernia treatment, not premarket approval for breast-specific applications
• FDA’s explicit warning: The November 2023 letter states “there are no surgical mesh products cleared or approved by the FDA for use in breast surgery, including in augmentation or reconstruction” and that safety and effectiveness have not been determined for these uses
• Off-label marketing concerns: Lawsuits allege manufacturers promoted these products for breast surgery applications without conducting breast-specific clinical trials or adequately warning patients about risks

The widespread use without FDA approval raises questions about patient safety, informed consent, and potential medical malpractice.

Manufacturers marketed these products to health care providers for breast surgery despite lacking clinical trial data and regulatory approval demonstrating safety and effectiveness for these applications.

If you underwent breast surgery involving mesh products that lacked FDA approval for breast applications and suffered complications, you may be entitled to compensation.

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

Women who received breast mesh implants report serious medical complications linked to these devices requiring additional surgeries.

Medical research documents complication rates including infections (3.61%), fluid buildup (5.04%), and reconstructive failure (13% of patients).

These complications impact quality of life and often require multiple revision procedures.

Studies show overall reoperation rates ranging from 15.5% to 18.8%, with approximately 8.6% requiring complete implant removal.

Short-Term Complications Within Six Months

Infections, delayed wound healing, tissue death, and early tissue reactions commonly occur within the first six months following mesh placement.

These early complications often signal problems with how the body responds to the implanted material.

Patients may experience any of the following early-stage complications:

• Infections and abscess formation: Meta-analysis shows a pooled infection rate of 3.61%, requiring antibiotic treatment or surgical drainage
• Delayed wound healing with fluid accumulation: Seroma occurs at a 5.04% rate, while hematoma affects 1.34% of patients, both potentially requiring drainage procedures
• Tissue necrosis and early mesh rejection: Fat necrosis occurs in approximately 0.86% of cases, with some patients experiencing signs of immune rejection

These complications typically manifest during the initial healing period and require prompt medical intervention.

Infections can spread rapidly, potentially leading to systemic illness if not treated aggressively.

Fluid accumulation may require repeated drainage procedures, prolonging recovery and increasing infection risk.

Long-Term Complications and Mesh Failures

Persistent issues often develop months to years after mesh placement, reflecting ongoing problems with mesh integration and device performance.

These long-term complications frequently require extensive revision surgery or complete implant removal.

Medical literature documents these persistent complications:

• Persistent pain and nerve damage: Chronic pain develops as mesh materials irritate surrounding tissue, while capsular contracture affects 2.51% of patients, causing breast hardening and discomfort
• Mesh migration and extrusion: Mesh materials may shift position or break through skin, requiring mesh removal and tissue repair
• Reconstructive failure requiring revision: Studies document 13% of patients experience reconstructive failure requiring implant removal, with overall reoperation rates between 15.5-18.8%

Long-term complications including chronic inflammation and scar tissue substantially impact quality of life and often necessitate complete removal of both mesh and breast implants.

Many women face multiple reconstructive surgeries as complications worsen over time, resulting in mounting medical expenses and prolonged physical and emotional distress.

Women who have experienced any of these complications following breast mesh surgery may qualify for legal action.

If you experienced persistent pain, mesh migration, reconstructive failure, or other long-term complications after breast mesh implantation, you may qualify for legal action.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine if you’re eligible to file a Breast Mesh Claim today.

Major medical device manufacturers face investigation for marketing mesh products for off-label breast surgery applications.

Lawsuits allege these companies promoted mesh products without adequate safety testing or proper warnings about risks.

BD updated their product labeling following FDA concerns, but allegations of insufficient warnings and unreported adverse events continue emerging through whistleblower disclosures.

GalaFLEX and Phasix Mesh by BD (Becton Dickinson)

BD’s GalaFLEX and Phasix product lines experienced widespread use in breast procedures despite receiving FDA clearance only for soft tissue repair.

These P4HB polymer-based mesh products became popular among plastic surgeons for breast reconstruction and augmentation surgical procedures.

BD’s product portfolio facing legal scrutiny encompasses:

• GalaFLEX Scaffold variations: GalaFLEX Lite, GalaFLEX 3D, and GalaFLEX 3DR versions made from poly-4-hydroxybutyrate (P4HB) polymer, marketed for tissue reinforcement
• Phasix Mesh products: Phasix Mesh and Phasix ST Mesh received clearance for soft tissue repair but were widely used in breast surgery
• Whistleblower allegations: Former BD medical director Dr. Hooman Noorchashm, a safety advocate, raised alarms about potential pro-oncogenic immune responses and unreported adverse events related to these products

The FDA addressed BD’s products in a November 2023 letter requiring labeling updates to clarify that these devices lack approval for breast surgery.

Lawsuits allege BD marketed these products to plastic surgeons for breast procedures while downplaying risks.

Other Manufacturers and High-Risk Products

Additional manufacturers face scrutiny after FDA identified specific products with notably higher rates of complications linked to mesh devices.

These findings regarding synthetic mesh outcomes parallel patterns seen in previous mass tort litigation involving surgical mesh devices.

Legal claims now target these additional manufacturers and devices:

• AlloMax and FlexHD: FDA analysis showed notably higher rates of explantation, reoperation, and infection for these acellular dermal matrix products manufactured by C.R. Bard/BD and Ethicon/Johnson & Johnson
• Widespread ADM usage: Acellular dermal matrix products were used in approximately 55% of immediate breast reconstruction procedures between 2015-2020
• Pattern of allegations: Claims mirror previous mesh litigation involving transvaginal and hernia mesh, including promoting unapproved uses, downplaying risks, and delaying warning updates despite accumulating adverse event reports

These allegations follow an established pattern in medical device litigation where manufacturers promoted products for applications beyond their regulatory clearance while failing to adequately warn physicians and patients about known risks.

If you received any of these mesh products during breast surgery and suffered complications, you may have grounds for legal action against the manufacturers.

If you received AlloMax, FlexHD, GalaFLEX, or Phasix mesh products during breast surgery and suffered infections, reoperation, or implant removal, you may have legal options.

Contact TruLaw using the chat on this page to receive an instant case evaluation and learn if you qualify to pursue a Breast Mesh Product Liability Lawsuit today.

Women who experienced complications from breast mesh implants have legal pathways to pursue compensation through product liability claims.

These lawsuits mirror successful mass tort patterns in previous mesh cases.

Product liability law compensates victims for economic losses including medical expenses and lost wages, plus non-economic losses such as pain and suffering.

Early case evaluation proves important for preserving legal rights.

Who Qualifies to File a Breast Mesh Lawsuit?

Women who underwent breast surgery involving internal bra mesh products and subsequently experienced complications may qualify for legal action.

Qualification depends on injury circumstances and documentation linking complications to mesh implantation.

Women may qualify to file lawsuits if they meet these criteria:

• Received breast mesh implants: Women who underwent breast reconstruction after mastectomy or cosmetic augmentation/lift procedures involving internal bra mesh products like GalaFLEX, Phasix, AlloMax, or FlexHD
• Experienced qualifying complications: Injuries including infection requiring treatment, persistent pain affecting daily life, mesh failure or migration, nerve damage, tissue damage, or reconstructive failure requiring revision surgery or implant removal
• Possess necessary documentation: Surgical records identifying the specific mesh product used, medical records documenting complications and treatments received, and records of any revision surgeries or ongoing care requirements

Product liability operates through the court system, allowing patients harmed by design, manufacturing, or marketing defects to bring lawsuits against manufacturers.

Timely action remains important as statute of limitations vary by state, typically two to four years from injury or discovery.

Types of Compensation Available in Breast Mesh Claims

Medical device litigation provides compensatory damages addressing financial losses and personal suffering from defective products.

Compensation calculations consider injury severity, reduced earning capacity, pain, and long-term quality of life impact.

Breast mesh claims provide access to the following damage categories:

• Medical expenses: Economic damages cover emergency treatment costs, revision surgery expenses, ongoing care, physical therapy and rehabilitation, and future medical needs
• Pain and suffering: Non-economic compensation addresses physical pain endured, emotional distress and psychological impact, diminished quality of life, and loss of enjoyment of normal activities
• Lost income and earning capacity: Economic damages include wages lost during recovery, income lost due to additional procedures, reduced earning capacity from permanent limitations, and compensation for career impact

Compensatory damages in medical device cases include economic losses like medical expenses and lost wages, plus non-economic losses such as pain and suffering.

Similar mesh litigation resulted in settlements ranging from individual awards to multi-million dollar verdicts based on injury severity.

The breast mesh lawsuit process begins with a thorough case evaluation.

TruLaw provides instant eligibility assessments and connects qualified claimants with breast mesh injury lawyers dedicated to pursuing the compensation they deserve.

Please be advised that any projected or estimated breast mesh lawsuit settlement amounts mentioned on this page are general estimations and are not guaranteed.

These figures are based on opinions of legal experts based on the nature of the injuries and estimated costs of damages.

They are meant to provide a general idea of what breast mesh settlement ranges could look like and should not be taken as definitive expectations for your case.

Contact TruLaw using the chat on this page to receive a free consultation and instant case evaluation.

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 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.

Internal bra lawsuits are being filed by women across the country who suffered serious complications from surgical mesh used in breast reconstruction and cosmetic surgery 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 internal bra 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.