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 have increasingly used 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 primary contexts:

• Breast reconstruction surgery after mastectomy involves surgeons placing 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 use mesh to provide internal support for implant placement and tissue repositioning.
• Material composition includes synthetic mesh such as P4HB (poly-4-hydroxybutyrate) polymer scaffolds, as well as acellular dermal matrices made from processed human or animal tissue.
• These products received FDA 510(k) clearance for soft tissue repair and reinforcement, though they have not been cleared or approved specifically for breast surgery applications.

These mesh products provide temporary structural support during the healing process. Manufacturers state 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 pursue a Breast Mesh Lawsuit 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 clearance or approval for breast applications. The FDA issued a letter to healthcare providers in November 2023 informing them of labeling updates to BD mesh products.

The regulatory landscape presents several key considerations:

• 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.
• The FDA’s November 2023 letter to healthcare providers 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 the safety and effectiveness of surgical mesh in breast surgery has not been determined by the FDA.
• Legal teams are examining whether manufacturers adequately warned healthcare providers and patients about the distinction between FDA clearance for soft tissue repair and the off-label use of these products in breast surgery.
• Healthcare providers can legally prescribe medical devices for off-label uses, though questions remain about informed consent and whether patients fully understood the regulatory status of these products.

The widespread use of these products in breast surgery—an application for which they have not received specific FDA clearance—raises questions about patient safety and informed consent. These products came to be widely used by healthcare providers for breast surgery despite lacking FDA clearance or approval specifically for breast applications.

If you underwent breast surgery involving mesh products that lacked specific FDA clearance 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 have reported medical complications following these procedures that required additional surgeries. Medical research documents complication rates including infections (3.61%), fluid buildup (5.04%), and reconstructive failure (13% of patients), though it should be noted that many of these complications can also occur in breast surgery without mesh.

These complications can impact quality of life and may 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 have been reported within the first six months following mesh placement. These early complications may signal problems with how the body responds to the implanted material, though similar complications can occur in breast surgery generally.

Patients have reported the following early-stage complications:

• Infections and abscess formation occur at a pooled rate of approximately 3.61% based on meta-analysis data, requiring antibiotic treatment or surgical drainage in affected patients.
• 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 (fat necrosis) occurs in approximately 0.86% of cases, with some patients experiencing signs of immune rejection or adverse tissue reactions.
• These complication rates should be considered in the context of general breast surgery risks, as similar complications occur in procedures without mesh.

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

Long-Term Complications Reported After Mesh Placement

Some patients report persistent issues developing months to years after mesh placement. As with all implantable medical devices, complications can occur for various reasons, and these issues are not necessarily unique to mesh use.

Medical literature documents these reported complications:

• Chronic pain may develop in some patients, while capsular contracture affects approximately 2.51% of patients, causing breast hardening and discomfort.
• Mesh migration and extrusion have been reported, where mesh materials may shift position or break through skin, requiring mesh removal and tissue repair.
• Studies document that approximately 13% of patients experience reconstructive failure requiring implant removal, with overall reoperation rates between 15.5-18.8%, though these rates reflect breast reconstruction outcomes generally and are not necessarily attributable to mesh alone.
• One comprehensive review of mesh use in breast surgery noted that there does not seem to be a marked difference in risk profile between breast surgeries with and without mesh use.

In some cases, long-term complications including chronic inflammation and scar tissue may substantially impact quality of life and necessitate complete removal of both mesh and breast implants. Some women face multiple reconstructive surgeries as complications develop over time, resulting in mounting medical expenses and prolonged physical and emotional distress.

Women who have experienced complications following breast mesh surgery may wish to consult with an attorney to evaluate potential legal options.

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.

Legal teams are reviewing the conduct of major medical device manufacturers regarding the marketing of mesh products for off-label breast surgery applications. Attorneys are examining whether these companies adequately tested and warned about risks associated with breast surgery applications.

BD updated their product labeling prior to the FDA’s November 2023 letter to healthcare providers. Separately, a former BD medical director has raised questions about adverse event reporting related to these products.

GalaFLEX and Phasix Mesh by BD (Becton Dickinson)

BD’s GalaFLEX and Phasix product lines have been widely used 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 under legal review encompasses:

• GalaFLEX Scaffold variations including GalaFLEX Lite, GalaFLEX 3D, and GalaFLEX 3DR versions are made from poly-4-hydroxybutyrate (P4HB) polymer and were cleared for tissue reinforcement applications.
• Phasix Mesh products including Phasix Mesh and Phasix ST Mesh received clearance for soft tissue repair and have been widely used in breast surgery despite lacking specific clearance for that application.
• Dr. Hooman Noorchashm, a former BD medical director and patient safety advocate, has raised questions about potential adverse events and reporting practices related to these products.
• BD states it has not marketed GalaFLEX or Phasix for breast surgery applications, and its Instructions for Use note that FDA has not determined safety and effectiveness for breast surgery.

The FDA addressed BD’s products in a November 2023 letter to healthcare providers informing them of labeling updates clarifying that these devices have not been cleared or approved for breast surgery. Attorneys are investigating how BD’s products came to be widely used in breast procedures despite being cleared only for soft tissue repair.

Other Manufacturers and High-Risk Products

Additional manufacturers are under review after FDA analysis identified specific products with notably higher rates of certain complications. These findings regarding surgical mesh outcomes parallel patterns seen in previous mass tort litigation involving surgical mesh devices.

Legal investigations now include these additional manufacturers and devices:

• AlloMax and FlexHD were identified in FDA analysis as showing notably higher rates of explantation, reoperation, and infection compared to other acellular dermal matrix products used in breast reconstruction.
• Acellular dermal matrix products were used in approximately 55% of immediate breast reconstruction procedures between 2015-2020, representing widespread use of these materials.
• The pattern of legal investigation mirrors previous mesh litigation involving transvaginal and hernia mesh, examining questions of off-label promotion, risk disclosure, and warning adequacy.
• These investigations follow an established pattern in medical device litigation where attorneys examine whether manufacturers adequately informed physicians and patients about uses beyond FDA clearance.

If you received any of these mesh products during breast surgery and suffered complications, you may wish to consult with an attorney about potential legal options.

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 Claim today.

Women who experienced complications from breast mesh implants may have legal pathways to pursue compensation through product liability claims. These potential claims follow patterns established in previous mesh litigation.

Product liability law allows individuals to seek compensation 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 within applicable statutes of limitations.

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 pursue legal claims if they meet these criteria:

• Women who underwent breast reconstruction after mastectomy or cosmetic augmentation/lift procedures involving internal bra mesh products like GalaFLEX, Phasix, AlloMax, or FlexHD may have potential claims.
• Qualifying complications may include 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.
• Documentation requirements typically include 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 claims allow patients harmed by alleged design, manufacturing, or marketing defects to bring legal action against manufacturers through the court system.

Timely action remains important as statutes of limitations vary by state, typically two to four years from injury or discovery. Consulting with an attorney promptly helps ensure legal rights are preserved.

Types of Compensation Available in Breast Mesh Claims

Medical device litigation may provide compensatory damages addressing financial losses and personal suffering from allegedly defective products. Compensation calculations typically consider injury severity, reduced earning capacity, pain, and long-term quality of life impact.

Breast mesh claims may provide access to the following damage categories:

• Medical expenses as economic damages may cover emergency treatment costs, revision surgery expenses, ongoing care, physical therapy and rehabilitation, and future medical needs related to mesh complications.
• Pain and suffering as non-economic compensation may address physical pain endured, emotional distress and psychological impact, diminished quality of life, and loss of enjoyment of normal activities.
• Lost income and earning capacity as economic damages may 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 typically include economic losses like medical expenses and lost wages, plus non-economic losses such as pain and suffering, with amounts varying based on individual circumstances.

Similar mesh litigation has resulted in settlements ranging from individual awards to multi-million dollar verdicts based on injury severity. The breast mesh claim process begins with a thorough case evaluation.

TruLaw provides eligibility assessments and connects individuals with breast mesh injury lawyers dedicated to pursuing compensation for those who may have valid claims.

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 evaluating and filing potential Breast Mesh claims. With extensive experience in product liability cases, Jessica Paluch-Hoerman and our partner law firms work with litigation leaders and medical experts to evaluate how mesh products may have caused harm.

TruLaw focuses on pursuing compensation for medical expenses, revision surgeries, pain and suffering, lost income, and other damages resulting from breast mesh injuries. We provide personalized guidance to those seeking to hold manufacturers accountable for alleged product defects.

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 pursue a Breast Mesh claim today.

Attorneys are investigating potential claims on behalf of women across the country who suffered serious complications from surgical mesh used in breast reconstruction and cosmetic surgery procedures. TruLaw is currently accepting consultations for potential Breast Mesh claims.

A few reasons to choose TruLaw for your Breast Mesh claim 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 potential Breast Mesh claims.
• 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 to pursue a Breast Mesh claim today.