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Thousands of patients have undergone breast surgeries involving surgical mesh products, often marketed as an “internal bra,” only to experience painful, life-altering complications. These patients trusted that the products used in their breast reconstruction, augmentation, or lift surgeries were tested, approved, and safe.
But according to allegations in breast mesh lawsuits, the manufacturers failed to warn of serious health risks, including infections, mesh migration, scarring, and pain.
The U.S. Food and Drug Administration (FDA) has confirmed that no surgical mesh product has been cleared or approved for use in breast surgery, including breast reconstruction, augmentation, or mastopexy (breast lift) procedures. Despite this, mesh products have been widely used off-label in these surgeries, and individuals are now reporting serious complications ranging from chronic pain and infection to complete reconstruction failure requiring additional operations.
At Wisner Baum, we are investigating breast mesh claims on behalf of anyone who believes they have suffered harm as a result of these devices. If you or someone in your family experienced complications following a breast procedure involving mesh, you may be entitled to compensation. Contact us today or call (310) 207-3233 for a free case evaluation. Our breast mesh attorneys represent clients on contingency, which means we only collect a fee if we successfully obtain compensation for you.
The breast mesh litigation is in its early stages. No formal multidistrict litigation (MDL) has been established, and no class action lawsuit has been certified. Individual lawsuits are being filed and investigated across the country. While there have been no breast mesh settlements or jury verdicts to date, it is worth noting that BD (Becton, Dickinson and Company), the manufacturer of two of the most widely used breast mesh products (GalaFLEX and Phasix), previously settled a large hernia mesh MDL, which may inform how future breast mesh claims against the company are evaluated and valued.
The transvaginal mesh litigation, which involved similar polypropylene and biologic mesh products used in pelvic floor repair, resulted in many thousands of lawsuits, with manufacturers collectively paying billions of dollars to resolve claims. Boston Scientific alone settled approximately 52,000 transvaginal mesh cases over multiple years, and other manufacturers, including C.R. Bard and Johnson & Johnson, paid hundreds of millions more.
Breast mesh is a surgical device made from synthetic polymers or biologic scaffolds derived from processed human or animal tissue. Surgeons implant these devices inside the breast to provide structural support. In practice, they can be used in several types of breast procedures, including:
The so-called “internal bra” technique involves placing a mesh scaffold beneath the breast tissue or implant to create a long-term sling intended to reduce sagging, stabilize implant position, and/or improve aesthetic outcomes over time.
While the concept sounds promising, the reality has allegedly been far more complicated for many patients.
Synthetic mesh products used in breast procedures are typically made from bioresorbable polymers that dissolve slowly as the body forms new connective tissue. Biologic mesh is created from processed human or animal tissue and is designed to integrate more naturally with surrounding anatomy.
Both types have been marketed as improvements over traditional surgical techniques, but neither category has been specifically approved by the FDA for use in the breast.
The central issue driving breast mesh litigation is straightforward: these products were never approved for the purpose they were being used for, and patients allege they were not adequately informed of that fact or the risk of harm.
The legal claims against breast mesh manufacturers generally focus on several key allegations, most notably:
These allegations are backed by peer-reviewed research documented alarming complication rates when surgical mesh is used in breast procedures.
A 2021 randomized controlled trial published in the Journal of Surgical Oncology found a total complication rate of 34% among patients who received breast mesh, with approximately 13% requiring complete implant removal. The study compared biological and synthetic mesh in the same patients and found that complication rates varied significantly by material. Per the authors, the biological mesh group experienced a 38% seroma rate, compared with 3.8% in the synthetic mesh group (Hansson et al., J Surg Oncol, 2021).
A 2025 meta-analysis of 13 studies and 1,305 patients published in Plastic and Reconstructive Surgery – Global Open found pooled complication rates of 3.61% for infection, 5.04% for seroma, and 2.5% for capsular contracture among patients who received synthetic mesh internal bra devices (Williams et al., PRS Global Open, 2025).
A 2024 systematic review in Aesthetic Surgery Journal Open Forum analyzing 31 studies found reoperation rates approaching 10% and implant loss in roughly 3% of cases involving synthetic mesh (Aesthetic Surgery Journal Open Forum, 2024).
These figures are especially significant given that the Mastectomy Reconstruction Outcomes Consortium has reported overall complication rates of 26.6% to 31.3% for implant-based breast reconstruction generally (Meshkin et al., Ann Transl Med, 2023), raising questions about whether the use of mesh provides a net benefit in breast surgery.
Over the last several years, the FDA has issued multiple communications raising concerns about the use of surgical mesh in breast surgery. Below is a timeline of FDA safety announcements and a notable warning from cosmetic surgeons concerning breast mesh:
In 2021, FDA warned about differing complication rates among acellular dermal matrix (ADM) products used in implant-based breast reconstruction. The agency’s analysis found that certain ADM products — specifically FlexHD and AlloMax — appeared to carry a higher risk of major complications, explantation, reoperation, and infection compared with other ADM brands or with not using ADM at all. This communication made clear that not all mesh products perform the same way and that risk profiles vary significantly by brand.
In November 2023, FDA issued a letter to healthcare providers regarding labeling updates for several Becton, Dickinson and Company (BD) mesh products, including Phasix and GalaFLEX. In that letter, the FDA stated explicitly that while it was aware of the increased use of mesh in breast surgeries, no surgical mesh product is cleared or approved for breast augmentation or reconstruction, and the benefit-risk profile for this use remains undefined. BD was required to update its product labeling to reflect these uncertainties and potential risks.
In late 2025, members of the medical community began raising public concerns about internal bra procedures. Among the most prominent voices was Dr. Hooman Noorchashm, a former medical director and safety monitor for BD, who has publicly stated that he raised safety concerns about GalaFLEX while employed by the company — including concerns about breast cancer recurrence in clinical trial patients that he alleges were not reported to the FDA as required.
Other plastic surgeons have cautioned that mesh products used in breast lifts and augmentations may offer limited proven benefit while exposing patients to serious risks, including infection, inflammation, deformity, and failed reconstruction.
Taken together, the regulatory notices and medical community warnings paint a clear picture: the FDA has not determined that breast mesh is safe and effective for use in breast surgery, and the risks may be substantially greater than what patients were told.
While the FDA has not issued a blanket recall of all breast mesh products, the agency has issued safety communications and labeling requirements that have put several manufacturers and products under heightened scrutiny. The following manufacturers and products have been identified in FDA safety communications, peer-reviewed medical literature, and/or legal investigations related to the off-label use of surgical mesh in breast procedures. This list may be updated as litigation develops.
Becton, Dickinson and Company (BD) — GalaFLEX Scaffold, Phasix Mesh, and AlloMax. BD is the most prominent company under investigation in breast mesh litigation. GalaFLEX, a bioresorbable scaffold made from poly-4-hydroxybutyrate (P4HB), was cleared by the FDA for soft-tissue reinforcement but has been widely used off-label in internal bra breast procedures. Phasix Mesh, also manufactured by BD, is similarly cleared for soft-tissue repair — not for breast surgery. In November 2023, the FDA issued a letter to healthcare providers requiring BD to update its labeling for these products to reflect that they have not been determined to be safe or effective for use in breast surgery. Through its 2017 acquisition of C.R. Bard, BD also inherited AlloMax, an acellular dermal matrix that the FDA specifically identified in its 2021 safety communication as having a higher risk of complications, including explantation, reoperation, and infection, compared with other ADM brands. BD settled approximately 38,000 hernia mesh lawsuits in October 2024 for an amount estimated to exceed $1 billion, establishing a pattern of litigation related to the company’s mesh products.
MTF Biologics — FlexHD. FlexHD is a human acellular dermal matrix used in implant-based breast reconstruction. The FDA’s 2021 safety communication specifically named FlexHD as having a higher risk profile than other ADMs, citing significantly higher rates of major complications, explantation, reoperation, and infection in an analysis of patient-level data from the Mastectomy Reconstruction Outcomes Consortium (MROC) study across 11 high-volume centers in the U.S. and Canada.
Allergan / LifeCell — AlloDerm. AlloDerm is one of the most widely used acellular dermal matrices in implant-based breast reconstruction. It is derived from donated human skin tissue and was one of the first ADMs adopted for breast reconstruction, though it has never been specifically approved by the FDA for that use. While the FDA’s 2021 MROC analysis found that AlloDerm had a comparatively lower complication profile than FlexHD and AlloMax, it remains under review as part of the broader category of mesh products used off-label in breast surgery. Allergan is also the manufacturer of Natrelle BIOCELL textured breast implants, which were voluntarily recalled in 2019 due to their association with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Integra LifeSciences — SurgiMend. SurgiMend is a bovine-derived acellular dermal matrix used in breast reconstruction. It was one of the ADM products evaluated in the FDA’s 2021 MROC analysis. In 2023, the FDA convened an advisory panel specifically to review Integra’s PMA submission for SurgiMend PRS, a product intended for use in implant-based breast reconstruction — reflecting the FDA’s broader effort to scrutinize mesh products being used in the breast. SurgiMend outcomes are being compared against higher-risk ADM brands in the ongoing litigation.
Ethicon (Johnson & Johnson) — Physiomesh and other surgical mesh products. Ethicon, a subsidiary of Johnson & Johnson, manufactures a range of surgical mesh products that have been used in various soft-tissue repair procedures. Ethicon’s Physiomesh was voluntarily withdrawn from the global market in 2016 after studies showed higher-than-expected rates of recurrence and reoperation in hernia repair. J&J and Ethicon were also major defendants in the transvaginal mesh litigation, with Ethicon paying $120 million in January 2016 to resolve over 2,000 cases and facing additional jury verdicts including an $80 million verdict in 2019. While the company’s involvement in breast-specific mesh claims is still being evaluated, its history of mesh-related litigation and product safety issues makes it a manufacturer of interest in this space.
Other manufacturers. Several additional companies manufacture synthetic and biologic mesh devices that have been used off-label in breast procedures. These include, but may not be limited to, manufacturers of polydioxanone (PDO) mesh scaffolds such as DuraSorb and other branded internal bra products marketed for soft-tissue reinforcement. As more patients come forward and more data is analyzed, additional manufacturers and products may be identified and added to this litigation.
If you are unsure whether a mesh product was used in your breast surgery, your operative report — which can be obtained from your surgeon’s office or the hospital where your procedure was performed — should identify the specific product by name and manufacturer. An attorney experienced in breast mesh litigation can also help you obtain and interpret these records.
Patients with breast mesh report a wide range of serious complications. In many cases, these complications do not appear immediately but develop weeks, months, or even years after the initial surgery. Reported complications include the following:
As attorneys with experience litigating medical device cases, we understand that these complications are not minor inconveniences; many patients have undergone two, three, or more additional surgeries to address adverse events caused by breast mesh and continue to endure significant physical pain, emotional distress, and financial hardship in the process.
If you have experienced any of the above after a breast mesh surgery, contact us today at (310) 207-3233 to discuss your legal options.
You may have a breast mesh claim if you underwent a procedure involving surgical mesh or an internal bra device and you subsequently experienced complications. Procedures that may involve breast mesh include:
If you experienced any complications after the procedures listed above, including chronic pain, infection, implant failure, tissue necrosis, deformity, or the need for additional corrective surgeries, you may qualify for a breast mesh lawsuit.
If you were not told that mesh was used in your procedure, if you were unaware the product was being used off-label, or if you only recently began experiencing symptoms, we encourage you to reach out to an attorney to discuss a potential claim. A lot of people who contact breast mesh lawyers say they did not know that mesh was implanted until they requested their operative reports or began investigating the cause of their complications.
At Wisner Baum, our legal team can help you obtain your medical records, identify the specific product used in your surgery, and evaluate whether you have a viable claim. There is no cost for an initial consultation.
Those who have been harmed by breast mesh products may be able to recover compensation for a broad range of losses. While every case is different and the specific damages available in a case depend on the facts of your situation, potential categories of compensation in breast mesh lawsuits include the following:
In cases involving particularly egregious or reckless conduct by manufacturers, punitive damages may also be available to punish the wrongdoer(s) and deter similar conduct in the future.
Every state has a statute of limitations that sets a deadline for filing a breast mesh lawsuit. If you miss that deadline, you may lose your right to pursue compensation entirely, regardless of the strength of your claim.
The specific time limit varies from state to state. In many jurisdictions, the clock does not begin running until the date you discovered (or reasonably should have discovered) that your injuries were caused by the mesh product. This is known as the “discovery rule,” and it can be particularly important in breast mesh cases because many complications develop gradually over time.
Because statutes of limitations are strict and the rules differ depending on where you live and the specific circumstances of your case, it is important to consult with an attorney as soon as possible. Waiting too long could jeopardize your ability to pursue the compensation you may be entitled to.
Wisner Baum is a nationally recognized plaintiffs' litigation firm with decades of experience handling complex product liability and mass tort cases against large corporations. Our attorneys have secured billions of dollars in verdicts and settlements on behalf of individuals harmed by dangerous products and corporate misconduct.
We understand the science and we have the resources required to hold medical device manufacturers accountable, even some of the largest in the world. Most importantly, we understand what our clients are going through. A breast mesh injury is not just a legal matter; this is a deeply personal experience that affects your health, your confidence, your relationships, and your daily life. We treat everyone who retains us with the compassion and individual attention their case deserves.
If you are dealing with complications from breast mesh or an internal bra procedure, we encourage you to contact us at (310) 207-3233 today. The consultation is free, confidential, and comes with no obligation. We will review your situation, help you understand your legal options, and advise you on the best path forward.
"Wisner Baum gave exceptional attention to all aspects of the case, detailed inquiry, and tenacious overview of all the information submitted. The paralegals are efficient and diligent. I was completely surprised to find an empathic personal message to take care of my own health during the challenging time of being a full-time caretaker.*"
In May of 2019, the jury in the case of Pilliod et al. v, Monsanto Company ordered the agrochemical giant to pay $2.055 billion in damages to the plaintiffs, Alva and Alberta Pilliod, a Bay Area couple in their 70s. R. Brent Wisner served as co-lead trial attorney for the Pilliods, delivering the opening and closing statements and cross-examining several of Monsanto’s experts. Wisner Baum managing shareholder, Michael Baum and attorney Pedram Esfandiary also served on the trial team in the Pilliod case.
The judge later reduced their award to $87M. Monsanto appealed the Pilliod’s verdict which the California Court of Appeal for the First Appellate District denied on August 9, 2021. Monsanto then requested the California Supreme Court review the appeal’s court decision, which the court denied on Nov. 17, 2021. Monsanto (Bayer) then submitted a petition for a writ of certiorari with the U.S. Supreme Court which SCOTUS denied on June 27, 2022, allowing the final judgment of $87M to remain intact.
$289.2 million jury verdict in Monsanto Roundup trial
Wisner Baum co-represented Dewayne “Lee” Johnson in the first Roundup cancer lawsuit to proceed to trial. On Aug. 10, 2018, a San Francisco jury ordered Monsanto to pay $39.25 million in compensatory damages and $250 million in punitive damages to Mr. Johnson, a former groundskeeper who alleged exposure to Monsanto’s herbicides caused him to develop terminal non-Hodgkin lymphoma.
Months after the jury verdict, the judge overseeing the trial reduced the punitive damages to $39.25 million. Mr. Johnson decided to accept the remittitur, bringing the adjusted amount awarded to Mr. Johnson $78.5 million.
Monsanto (Bayer) appealed the verdict and Johnson cross appealed. On July 20, 2020, the First Circuit Court of Appeals upheld the verdict against Monsanto but reduced Mr. Johnson’s award to $20.5 million. The company chose not to take the case to the U.S. Supreme Court, ending the litigation.
In 2016, Wisner Baum attorney Timothy A. Loranger and six other attorneys in the Plaintiffs’ Management Committee were able to secure a $265 million settlement for victims of the 2015 Amtrak 188 derailment in Philadelphia, one of the largest in the U.S. for 2016.
A breast mesh lawsuit is a civil legal claim filed by an individual who experienced complications after a breast procedure involving surgical mesh or an internal bra device. These lawsuits allege that manufacturers failed to adequately test their products for use in breast surgery, promoted the products for unapproved purposes, and failed to warn patients and surgeons about the specific risks involved. The goal of the lawsuit is to recover compensation for the injuries and losses caused by the defective product.
No. The FDA has confirmed that no surgical mesh product is currently cleared or approved for use in breast augmentation, reconstruction, or lift procedures. Any use of surgical mesh in these procedures is considered off-label use. In 2023, the FDA issued a letter to healthcare providers explicitly stating this and requiring manufacturers to update their product labeling accordingly.
The internal bra is a surgical technique in which a mesh scaffold is implanted beneath the breast tissue or implant to act as an internal support structure. It is used in breast augmentation, reconstruction, and lift procedures to reduce sagging and stabilize implant position. Despite its growing popularity among some plastic surgeons, the mesh products used in this technique have never been specifically approved for breast surgery by the FDA.
Reported complications include chronic pain, infection, abscess formation, tissue necrosis, delayed wound healing, capsular contracture, mesh migration, seroma (fluid buildup), mesh extrusion, reconstruction failure, implant loss, breast deformity, permanent scarring, and the need for multiple revision surgeries. Some patients also report nerve damage, tightness, and reduced range of motion in the chest and arm.
Several products and manufacturers are under investigation, including GalaFLEX Scaffold and Phasix Mesh by BD (Becton, Dickinson and Company), AlloMax (inherited by BD through its acquisition of C.R. Bard), FlexHD by MTF Biologics, AlloDerm by Allergan/LifeCell, and SurgiMend by Integra LifeSciences. This list may expand as litigation continues.
Your operative report should identify any products implanted during your surgery, including the specific type and brand of mesh. You can request this report from your surgeon’s office or the hospital where your procedure was performed. An attorney can also help you obtain and review these records.
As of early 2026, there is no certified breast mesh class action lawsuit or formal multidistrict litigation (MDL). Cases are currently being filed and investigated individually. However, as the number of claims grows, consolidation into an MDL or other coordinated proceeding is possible.
It is too early in the litigation to predict specific settlement amounts or verdict ranges for breast mesh cases. The value of any individual case depends on the severity of the complications, the number of surgeries required, the impact on the patient’s daily life and ability to work, and other case-specific factors. Prior mesh litigation, such as transvaginal mesh cases, resulted in individual settlements ranging from tens of thousands to hundreds of thousands of dollars or more, though past results do not guarantee future outcomes.
The deadline to file a lawsuit varies by state and depends on the applicable statute of limitations. In many states, the clock begins running when you discover (or should have discovered) that your injuries were related to the mesh product. Because these deadlines are strict, it is important to consult with an attorney promptly to ensure your rights are preserved.
No. Wisner Baum offers free, confidential consultations for potential breast mesh clients. We handle these cases on a contingency fee basis, meaning you pay no attorney fees unless we recover compensation on your behalf.
