GalaFLEX & Phasix Breast Mesh Lawsuit | Law Offices of Steven Gacovino P.C.
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Were you implanted with GalaFLEX or Phasix mesh during breast reconstruction, augmentation, or reduction surgery — and later suffered necrosis, capsular contracture, infection, seroma, or revision surgery? You may be entitled to significant financial compensation.
The Law Offices of Steven Gacovino P.C. and our national partners are actively investigating claims against Becton, Dickinson and Company (BD) on behalf of injured women nationwide.
Contact us today for a free, completely confidential consultation. If we don’t win, you don’t pay.
What Is the GalaFLEX & Phasix Breast Mesh Lawsuit? What You Need to Know Right Now
Thousands of women across the United States underwent breast reconstruction, augmentation, or reduction surgery only to discover — often months or years later — that the surgical mesh implanted in their bodies was causing serious, debilitating, and sometimes permanent harm. The products at the center of this emerging national litigation are GalaFLEX and Phasix, both manufactured by Becton, Dickinson and Company (BD).
These mesh products were marketed and sold to plastic surgeons as an “internal bra” — a structural scaffold designed to support breast implants and tissue — and became widely used in breast procedures across the country. But here is the critical fact at the heart of every lawsuit being filed: no surgical mesh product has ever been cleared or approved by the FDA for use in breast surgery.
GalaFLEX and Phasix received FDA clearance only for soft tissue repair in areas like hernia treatment — not for breast reconstruction or augmentation. Every woman who received these devices in a breast surgery received them in an off-label application that was never adequately studied for safety.
In November 2023, the FDA sent a formal letter to healthcare providers stating unambiguously: “The safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.” Becton Dickinson was required to update its product labeling.
Yet women who underwent these procedures beginning as early as 2015 had already been implanted — without adequate warning, and without informed consent reflecting the true risks they were taking on.
The Basis for Breast Mesh Harm Lawsuits
The core legal claim is straightforward and powerful: Becton Dickinson promoted and sold products for breast surgery procedures those products had never been approved for, without adequate safety testing, and without adequately warning surgeons or patients — and women were seriously harmed as a direct result. Former Becton Dickinson medical director Dr. Hooman Noorchashm — a cardiothoracic surgeon and patient safety advocate — has publicly stated that he raised internal safety concerns about GalaFLEX while employed by the company, including concerns about breast cancer recurrence in clinical trial patients that he alleges were not properly reported to the FDA. He was fired by BD in 2022 after objecting to what he describes as unsafe off-label marketing of GalaFLEX for breast procedures. His public statements provide powerful evidence of what BD’s own leadership knew — and chose not to act on.
In October 2024, Becton Dickinson settled approximately 38,000 hernia mesh lawsuits for an amount estimated to exceed $1 billion — establishing a clear and documented pattern of mesh-related liability that is directly relevant to the breast mesh litigation now building.
GalaFLEX and Phasix: What These Breast Mesh Products Are and Why They Are Dangerous
Understanding the products at the center of this litigation is essential to understanding your rights. Both GalaFLEX and Phasix are manufactured by Becton Dickinson — the same company that in 2024 agreed to pay more than an estimated $1 billion to settle approximately 38,000 hernia mesh lawsuits, establishing a significant pattern of liability for its mesh products.
GalaFLEX is a bioresorbable scaffold made from poly-4-hydroxybutyrate (P4HB), a synthetic polymer. It was marketed as a temporary internal support structure designed to reinforce soft tissue while the body’s own collagen grows around it, theoretically absorbing into the body over approximately 18 to 24 months. Becton Dickinson acquired GalaFLEX through its purchase of Tepha Inc. and Galatea Surgical. GalaFLEX products used in breast surgeries include the GalaFLEX Scaffold, GalaFLEX Lite, GalaFLEX 3D, and GalaFLEX 3DR. Plastic surgeons began widely adopting these devices for breast procedures — sometimes describing them to patients as receiving a “forever bra” or permanent internal support — but the device was never cleared by the FDA for breast applications. Reports in the FDA’s MAUDE adverse event database document GalaFLEX implants linked to capsular contracture, revision surgeries, infection, seroma, and necrosis. Critically, multiple patients have reported that the GalaFLEX mesh did not absorb as expected, instead remaining in the body long after the anticipated absorption window and causing ongoing chronic inflammation, pain, and structural failure.
Phasix Mesh, also manufactured by Becton Dickinson through its acquisition of C.R. Bard, is similarly constructed from P4HB polymer. It was originally developed and cleared for hernia repair and general soft-tissue reinforcement — not for breast surgery. Like GalaFLEX, Phasix was cleared through the FDA’s 510(k) process, which does not require proof of safety and effectiveness for specific new applications. Phasix was widely adopted for off-label use in breast reconstruction and augmentation procedures despite never being tested or approved for those applications. The FDA’s 2023 letter to healthcare providers explicitly named Phasix alongside GalaFLEX, requiring updated labeling to reflect that these devices had not been studied for breast surgery. FDA adverse event reports describe Phasix devices requiring removal due to complications, including at least one documented MAUDE report involving mesh fracture requiring reoperation.
Many patients were told by their surgeons that GalaFLEX or Phasix would function as a “forever bra” — providing permanent internal support for their implants or reconstructed tissue. This characterization, widely used in marketing directed at plastic surgeons, implied long-term structural benefit that the FDA had never validated and that has not been established by clinical evidence. Women who consented based on this representation may have additional grounds for claims based on inadequate informed consent.
Both GalaFLEX and Phasix reached the market through FDA 510(k) clearance — a pathway that requires only that a product is “substantially equivalent” to a previously cleared device, not that it is safe and effective for specific new uses. Neither product was ever studied or approved for breast surgery. The widespread off-label use in breast procedures was driven by manufacturer marketing, not FDA authorization — a fact that sits at the center of every lawsuit now being filed.
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GalaFLEX & Phasix Breast Mesh Complications: Understanding Each Injury and Its Legal Significance
The complications reported by women who received GalaFLEX or Phasix breast mesh are not minor inconveniences. They are serious medical events that have caused lasting physical harm, required additional surgeries, and devastated the quality of life of thousands of women who sought breast surgery hoping to improve their health or confidence. Below is a detailed explanation of each qualifying injury, its connection to the mesh, and why it matters in your legal claim.
Skin Necrosis — Tissue Death
Skin necrosis — the death of skin and underlying tissue — is among the most severe complications associated with GalaFLEX and Phasix breast mesh. It occurs when the inflammatory response triggered by the foreign mesh material compromises blood supply to the overlying skin and tissue, causing cells to die. Necrosis can manifest as blackened or darkened skin, open wounds, foul-smelling discharge, and in severe cases, deep tissue destruction that exposes the underlying implant or chest wall.
The connection between breast mesh and necrosis is well documented. Studies have found that synthetic mesh materials like GalaFLEX can provoke an exaggerated immune and inflammatory response in surrounding tissue, restricting the microcirculation that keeps skin cells alive. Because many breast reconstruction patients — particularly those who have undergone mastectomy — already have compromised tissue and thinner skin flaps, the introduction of a foreign mesh scaffold dramatically elevates the risk of necrosis. When necrosis occurs after breast mesh implantation, it frequently requires debridement (surgical removal of dead tissue), implant removal, additional reconstruction, and in some cases skin grafting. The physical and emotional toll is profound.
Capsular Contracture — Painful Hardening of the Breast
Capsular contracture occurs when the body’s natural scar tissue response around a breast implant becomes excessive and abnormal, causing the capsule to tighten, harden, and contract around the implant. The result is a breast that feels firm, distorted, and often intensely painful — sometimes described by patients as feeling like the breast is being squeezed in a vice. In advanced stages (Baker Grade III and IV), the breast becomes visibly deformed and the pain becomes constant and debilitating.
GalaFLEX and Phasix mesh were actually marketed to plastic surgeons with the implication that they would reduce the risk of capsular contracture by stabilizing the implant pocket and modulating scar response. The tragic irony documented in adverse event reports and medical literature is that the presence of a foreign mesh scaffold can actually trigger or worsen capsular contracture by initiating a heightened inflammatory response that drives the very myofibroblast activation responsible for pathological scar formation. When capsular contracture occurs in a patient who has also received breast mesh, the mesh itself can become embedded in the hardened capsule, making surgical correction far more complex and requiring additional operations to remove both the hardened tissue and the mesh material.
Infection and Abscess — Including Late-Onset Infection
Infection and abscess formation following breast mesh implantation can occur both acutely (within days to weeks of surgery) and, critically, on a delayed basis — months or even years after the procedure. Late-onset infection, occurring 60 or more days after implantation, is a well-recognized complication of synthetic mesh in any anatomical location and has been specifically documented in GalaFLEX and Phasix cases. This delayed infection pattern is significant because it often catches patients and physicians off guard, leading to misdiagnosis and delayed treatment that allows the infection to progress.
Surgical mesh creates a porous, biofilm-friendly surface within the body. Bacteria can colonize the mesh structure in ways that are effectively shielded from both the body’s immune response and systemic antibiotics — creating a protected reservoir of infection that can smolder for months before producing obvious symptoms or erupting into a full abscess. When mesh-related infection is diagnosed, it almost always requires surgical intervention: drainage, debridement, and frequently the removal of both the mesh and the breast implant. Patients who receive this diagnosis face additional major surgery, prolonged antibiotic treatment, potential permanent tissue damage, and the emotional devastation of losing their reconstruction outcome.
Seroma — Chronic Fluid Accumulation
A seroma is an accumulation of serous fluid in a cavity created by surgery — in this case, within the breast pocket following mesh implantation. While minor seromas sometimes resolve on their own, chronic or recurring seromas associated with breast mesh represent a serious complication requiring repeated medical intervention. Clinical data documents a seroma rate of approximately 5% in breast mesh procedures.
The relationship between GalaFLEX, Phasix, and seroma formation is biologically direct. The P4HB polymer mesh material triggers an ongoing inflammatory response as the body attempts to process the foreign material, stimulating fluid production in the surrounding tissue. Patients with mesh-related seromas experience swelling, pressure, tenderness, and visible distortion of the breast. Treatment typically requires repeated needle aspiration to drain the fluid — a painful, recurring procedure — or, in persistent cases, surgical intervention to address the underlying cause. Seromas also significantly increase the risk of subsequent infection, creating a cascade of complications that can ultimately result in implant loss.
Nerve Damage — Chronic Pain and Sensory Dysfunction
Nerve damage associated with GalaFLEX and Phasix breast mesh can manifest as chronic pain, burning sensations, shooting or stabbing pain, numbness, tingling, hypersensitivity, or complete loss of sensation in the breast and surrounding chest wall area. This neuropathic injury can result from the mechanical compression of nerves by the mesh scaffold or developing scar tissue, from the inflammatory environment created by the mesh triggering chemical sensitization of pain receptors, or from direct nerve trauma during the surgical placement of the mesh device.
What makes nerve damage particularly devastating is its persistence. Unlike other surgical complications that may resolve with treatment, nerve injuries can become chronic pain conditions that significantly impair quality of life indefinitely. Patients have reported that even after explant surgery — the removal of the mesh — neuropathic pain has continued, suggesting that permanent nerve injury occurred during the period the mesh was in place. This long-term pain burden translates directly into significant compensable damages, including ongoing medical treatment costs, pain and suffering, and the impact on ability to work and participate in daily life.
Mesh Migration and Displacement
Mesh migration or displacement occurs when GalaFLEX or Phasix mesh shifts from its originally implanted position within the breast. This movement can distort the breast’s shape, compromise the support it was intended to provide, and create new areas of pressure, pain, and tissue injury wherever the mesh migrates. FDA MAUDE adverse event reports describe instances where mesh shifted, detached, or failed to remain in position — sometimes identified only during follow-up imaging or during revision surgery. By the time migration is identified, significant secondary damage — including tissue erosion, asymmetry, and compromised implant support — may have already occurred. Migrated mesh material can become embedded in scar tissue in its new location, making surgical removal substantially more complex.
Explant, Revision Surgery, and Reconstructive Failure
For many women, the ultimate consequence of GalaFLEX or Phasix breast mesh complications is the need for explant surgery (removal of the mesh), revision surgery (corrective procedures to address mesh-related damage), or complete reconstructive failure — the loss of the reconstruction outcome entirely. Clinical data documents reoperation rates of 15.5% to 18.8% in breast mesh procedures, with approximately 13% of patients experiencing complete reconstructive failure requiring implant removal when synthetic mesh was used.
Explant surgery for embedded breast mesh — particularly when the mesh has become incorporated into scar tissue, capsule, or chest wall — can be extraordinarily complex, carrying significant risks of additional nerve injury, bleeding, and further compromised tissue. Patients who undergo explant surgery face extended recovery, potential permanent disfigurement, breast asymmetry, and often the need for yet another reconstructive procedure to rebuild what was lost. For women who underwent the original breast surgery as part of cancer treatment — a mastectomy reconstruction — the failure of that reconstruction carries an additional layer of trauma and loss that goes far beyond the physical.
Implant Rupture
Implant rupture — the failure of a breast implant — can be directly caused or accelerated by the presence of GalaFLEX or Phasix mesh. When mesh-related complications including infection, seroma, capsular contracture, or mechanical stress compromise the structural environment of the breast pocket, the risk of implant shell failure increases substantially. A ruptured implant requires immediate surgical intervention, and when the rupture occurs in the context of pre-existing mesh complications, the surgical management becomes significantly more complex.
FDA Warnings, Labeling Actions, and the Regulatory Timeline Every Plaintiff Needs to Know
The regulatory history of GalaFLEX and Phasix is a critical foundation of every breast mesh lawsuit. It demonstrates what Becton Dickinson knew, when they knew it, and what they were ultimately required to do — building the evidentiary timeline that attorneys use to prove the manufacturer’s liability.
Between 2014 and 2015, GalaFLEX received FDA 510(k) clearance for soft tissue reinforcement in procedures such as hernia repair. The clearance did not cover breast surgery of any kind. Despite this, the product immediately began to be marketed to plastic surgeons for off-label use in breast reconstruction and augmentation — an application the FDA had never evaluated.
From 2015 through 2022, GalaFLEX and Phasix became increasingly popular in breast plastic surgery, marketed to surgeons as an “internal bra” system. Women underwent breast procedures without being informed that the mesh devices had never been approved for breast applications and had not been studied for safety in breast tissue. Adverse events — including infections, seromas, and capsular contracture — accumulated in the FDA’s MAUDE database throughout this period.
In 2022, former Becton Dickinson medical director Dr. Hooman Noorchashm was fired after objecting to what he describes as unsafe off-label marketing of GalaFLEX for breast procedures and after raising concerns about adverse event reporting practices. His subsequent public statements constitute some of the most powerful evidence of corporate knowledge of risk that exists in this litigation.
In November 2023, the FDA sent a formal letter to healthcare providers requiring Becton Dickinson to update the labeling of GalaFLEX, Phasix, and related products. The FDA stated explicitly that the safety and effectiveness of surgical mesh in breast surgery had not been determined, urged surgeons to fully inform patients of these risks, and acknowledged that prior labeling had been inadequate. This regulatory action confirms both that the risks were real and that patients had not previously received adequate warnings.
In October 2024, Becton Dickinson agreed to settle approximately 38,000 hernia mesh lawsuits for more than an estimated $1 billion. Three of four bellwether hernia mesh trials that preceded the settlement resulted in plaintiff verdicts. The breast mesh litigation is poised to follow the same trajectory — and is currently at the stage where early claimants can position themselves most favorably.
In 2025 and 2026, the first formal GalaFLEX breast mesh lawsuits were filed in Rhode Island state court, where BD maintains its surgical mesh headquarters. Law firms nationwide, including the Law Offices of Steven Gacovino P.C. and its national partners, began actively accepting and investigating claims on behalf of injured women across all 50 states.
Do You Qualify for a GalaFLEX or Phasix Breast Mesh Lawsuit?
Our attorneys are actively accepting cases that meet all of the following criteria. The consultation is completely free and confidential — and you pay nothing unless we win your case.
To qualify, all of the following must be true: the injured party must be female; breast reconstruction, augmentation, or reduction surgery must have been performed between 2015 and the present; GalaFLEX or Phasix mesh must have been implanted during that breast surgery; and the patient must have experienced at least one of the following complications after the mesh was implanted: nerve damage; infection or abscess occurring 60 or more days after implantation; seroma; capsular contracture; mesh migration or displacement; explant or revision surgery; reconstructive failure; implant rupture; or skin necrosis.
Many women are uncertain whether they received GalaFLEX, Phasix, or another brand of mesh during their breast surgery. The most reliable way to confirm is to obtain your operative report from the hospital or surgical center where your procedure was performed — it will list every device implanted, including the manufacturer and product name. You can also ask your surgeon directly or review any implant documentation you received. Many women who received GalaFLEX or Phasix were told during their surgical consultation that they were receiving an “internal bra,” a “scaffold,” a “biologic mesh,” or simply a “supportive structure” — if you heard any of these terms in connection with your breast surgery, there is a meaningful possibility you received one of these products.
If you are having difficulty obtaining your records, our attorneys and support staff can assist you at no cost as part of your free consultation. Do not let uncertainty about the product name stop you from calling us — that is exactly the type of investigation we do on every case.
Time limits apply. Personal injury statutes of limitations vary by state and typically range from one to six years. However, many states apply a “discovery rule” that starts the clock from the date you knew or reasonably should have known that your injury was linked to the mesh — which can extend your filing window significantly. The only way to know for certain whether your claim is timely is to speak with an attorney as soon as possible. Do not assume it is too late.
What You Can Sue For: Legal Claims, Types of Damages, and What Your Case May Be Worth
When you file a GalaFLEX or Phasix breast mesh lawsuit with the Law Offices of Steven Gacovino P.C. and our national partners, you are bringing a product liability claim against Becton Dickinson on multiple independent legal theories — each supported by powerful evidence including FDA regulatory findings, internal company documents, and the public testimony of the company’s own former medical director.
The primary legal claims in these cases include failure to warn — Becton Dickinson failed to adequately warn surgeons and patients that GalaFLEX and Phasix had never been tested or approved for breast surgery and carried unknown, potentially serious risks when used in breast applications. The 2023 FDA labeling update confirms that the prior labeling was inadequate. Claims also include defective design — the design and application of these mesh products in breast tissue was unreasonably dangerous, and the mesh’s inflammatory properties, failure to resorb predictably, and structural behavior in breast tissue created a foreseeable risk of serious injury. Negligent off-label marketing is a third theory — BD actively marketed GalaFLEX and Phasix for breast surgery applications without FDA clearance and without adequate clinical safety data, directly driving the widespread adoption that led to widespread patient harm. Additional claims include fraud and misrepresentation, strict products liability, and breach of warranty.
Women who were injured by GalaFLEX or Phasix breast mesh may be entitled to recover compensation across multiple categories of damages. Medical expenses — both past and future — include all costs of treating mesh-related complications: additional surgeries, hospitalization, antibiotics, wound care, physical therapy, specialist consultations, and the projected cost of all future care related to your injuries. Pain and suffering damages cover the physical pain and emotional suffering caused by your complications, including chronic pain, neuropathic pain, anxiety, depression, body image disturbance, and the psychological impact of a life-altering medical complication. Lost wages and earning capacity damages address income lost during recovery from mesh-related surgeries and treatment, plus any reduction in future earning capacity resulting from chronic pain, disability, or ongoing medical needs. Disfigurement and permanent injury damages compensate for permanent physical disfigurement — scarring, asymmetry, breast deformity, or loss of breast tissue — and for any permanent disability or lasting functional impairment. Loss of enjoyment of life damages address the impact of your injuries on your ability to engage in activities, hobbies, relationships, and experiences that defined your life before your complications. And where the evidence supports a finding that Becton Dickinson’s conduct was reckless, willful, or fraudulent — including the alleged suppression of adverse event data and continued promotion of off-label use despite known risks — punitive damages may be available.
No breast mesh cases have yet reached trial or settlement — this is early-stage litigation with significant potential for injured claimants who move promptly. The comparable hernia mesh litigation provides meaningful context. BD’s 2024 hernia mesh settlement covering approximately 38,000 claims was estimated to exceed $1 billion, with bellwether trial verdicts reaching as high as $4.8 million for individual claimants. Breast mesh cases involve the additional dimension of bodily disfigurement, cancer reconstruction context, and more intimate physical harm — factors that have historically driven higher non-economic damage awards in comparable litigation. Our attorneys will evaluate your specific injuries, medical history, and damages during your free consultation and provide an honest assessment of what your claim may be worth.
The Law Offices of Steven Gacovino P.C. — National Reach, Personal Commitment
The Law Offices of Steven Gacovino P.C. has spent over 30 years fighting for individuals harmed by negligent corporations and defective medical products. Our firm is now actively investigating GalaFLEX and Phasix breast mesh claims in partnership with a national network of mass tort litigation specialists — giving clients the combined resources of a nationally recognized litigation team with the personal attention and direct attorney access that defines our practice.
Mass tort litigation against major corporations like Becton Dickinson requires a specific combination of resources: deep medical device expertise, access to expert witnesses in biomedical engineering and plastic surgery, established relationships in the mass tort litigation community, and the financial resources to take on a Fortune 500 company. Our national partnership structure brings all of these capabilities to bear on behalf of every client we represent.
The Law Offices of Steven Gacovino P.C. is co-counseling GalaFLEX and Phasix breast mesh cases with national mass tort partners who have handled complex defective medical device litigation at scale across the country. This network provides clients with access to the most experienced breast mesh litigators in the country, while ensuring they receive the direct, personal communication and dedicated attention that Steven Gacovino’s firm has always delivered.
We handle all breast mesh claims on a 100% contingency fee basis. There is no upfront cost, no retainer, and no fee of any kind unless and until we recover compensation for you. We advance all case expenses — including medical record retrieval and expert witness fees — and we only receive a fee if we win. This arrangement ensures that every injured woman has access to the same quality legal representation regardless of her financial situation.
We represent breast mesh victims in all 50 states through our national partner network. No matter where you live or where your surgery was performed, our team can evaluate and pursue your claim. Virtual consultations are available. The consultation itself is completely free and is protected by attorney-client privilege — everything you share with us is completely confidential.
One additional point worth emphasizing: in major mass tort litigation, early claimants who move before the litigation becomes crowded often receive priority in settlement negotiations and benefit from the most favorable resolution timelines. The breast mesh litigation is at a critically early stage right now. Contacting us today protects your position in the litigation timeline.
Contact Us Today for a Free, Confidential Consultation
If you received GalaFLEX or Phasix mesh during breast reconstruction, augmentation, or reduction surgery and experienced any of the complications described on this page — including necrosis, capsular contracture, infection, seroma, nerve damage, mesh migration, revision surgery, reconstructive failure, or implant rupture — you may be entitled to significant financial compensation.
The Law Offices of Steven Gacovino P.C. and our national partners are ready to evaluate your case today. Your consultation is completely free, completely confidential, and protected by attorney-client privilege. We represent clients in all 50 states. Virtual consultations are available. We will help you obtain your medical records. And if we take your case, you pay nothing unless we win.
Complete the form above or call us at 844-692-1200 for a free, confidential consultation about your situation. Do not wait — statutes of limitations apply and the time to act is now.
This content is provided for general informational purposes only and does not constitute legal advice or create an attorney-client relationship. Prior results do not guarantee similar outcomes. The Law Offices of Steven Gacovino P.C. is co-counseling these matters with national mass tort partner firms.
GalaFLEX & Phasix Breast Mesh Lawsuits - Frequently Asked Questions (FAQ’s)
What is GalaFLEX mesh and why is it the subject of lawsuits?
GalaFLEX is a bioresorbable surgical scaffold made from poly-4-hydroxybutyrate (P4HB) polymer, manufactured by Becton, Dickinson and Company (BD). It was marketed to plastic surgeons as an “internal bra” for use in breast reconstruction and augmentation surgery — despite never having been cleared or approved by the FDA for use in breast surgery. Lawsuits allege that BD promoted GalaFLEX for off-label breast surgery use without adequate safety testing and without warning surgeons or patients of the risks, leading to serious complications including necrosis, infection, capsular contracture, and revision surgeries in thousands of women.
What is Phasix mesh and how is it related to GalaFLEX?
Phasix Mesh is another P4HB-based surgical mesh product manufactured by Becton Dickinson, inherited through BD’s acquisition of C.R. Bard. Like GalaFLEX, Phasix was cleared by the FDA for soft tissue repair — not for breast surgery — and was used off-label in breast reconstruction and augmentation procedures across the United States. The FDA’s November 2023 letter to healthcare providers explicitly named both GalaFLEX and Phasix and required BD to update their labeling to reflect that these products have not been determined to be safe or effective for breast surgery. Both are the subject of the current national litigation investigation.
How do I know if I received GalaFLEX or Phasix mesh during my breast surgery?
The most reliable way to confirm is to obtain your operative report from the hospital or surgical center where your procedure was performed — it will list every device implanted, including manufacturer and product name. You can also contact your surgeon’s office directly. Many women who received GalaFLEX or Phasix were told they were receiving an “internal bra,” “scaffold,” or “supportive mesh” — if you heard any of these terms related to your breast surgery, there is a meaningful possibility you received one of these products. Our attorneys can help you obtain and review your medical records as part of your free consultation at no charge.
What complications qualify for a lawsuit?
Our attorneys are accepting cases involving the following complications after GalaFLEX or Phasix breast mesh implantation: nerve damage; infection or abscess occurring 60 or more days after implantation; seroma; capsular contracture; mesh migration or displacement; explant or revision surgery; reconstructive failure; implant rupture; and skin necrosis. You must have experienced at least one of these complications after receiving GalaFLEX or Phasix during breast reconstruction, augmentation, or reduction surgery performed between 2015 and the present.
Does the mesh need to have been removed for me to file a lawsuit?
No. You do not need to have had the mesh surgically removed to be eligible. If you experienced qualifying complications — including infection, chronic pain, seroma, capsular contracture, necrosis, or other injuries listed above — you may be eligible regardless of whether the mesh was explanted. Call us to discuss your specific situation and receive a frank assessment of your eligibility.
Is it too late to file a breast mesh lawsuit?
Whether your claim is time-barred depends on your state’s statute of limitations and the specific timeline of your injury. Many states apply a “discovery rule” that starts the clock from the date you knew or reasonably should have known that your injury was caused by the mesh — which can significantly extend your filing window. The only way to know for certain is to speak with an attorney as soon as possible. Do not assume it is too late — call us for a free evaluation of your specific situation.
How much does it cost to hire a breast mesh attorney?
Nothing upfront. The Law Offices of Steven Gacovino P.C. handles all breast mesh claims on a 100% contingency fee basis. There is no retainer, no consultation fee, and no out-of-pocket cost. We advance all case expenses and only receive a fee if we successfully recover compensation on your behalf. If we do not win, you do not pay.
Has GalaFLEX or Phasix mesh been recalled?
As of this writing, neither GalaFLEX nor Phasix has been formally recalled. However, the FDA issued a formal letter to healthcare providers in November 2023 requiring BD to update the labeling of these products to reflect that their safety and effectiveness in breast surgery has not been determined. The absence of a recall does not mean these products are safe, and the lawsuits being filed are based on product liability and failure to warn claims that exist independently of whether a formal recall is issued.
What is the "internal bra" procedure and is it the same as receiving breast mesh?
Yes. The “internal bra” is a marketing term used to describe a breast surgery technique in which surgical mesh — including GalaFLEX or Phasix — is implanted inside the breast to provide structural support for implants or reconstructed tissue. If you were told you were receiving an “internal bra” procedure or an “internal support system” as part of your breast surgery, you almost certainly received GalaFLEX, Phasix, or another brand of breast mesh — and this is a qualifying procedure for the litigation our attorneys are currently investigating.
What if my breast surgery was for cancer reconstruction?
Women who received GalaFLEX or Phasix as part of post-mastectomy breast reconstruction following breast cancer treatment are absolutely eligible for these claims — and in many cases, the harm they suffered is even more significant. Women who underwent mastectomy reconstruction had already faced a devastating illness, only to have their recovery compromised by a defective medical device. The physical disfigurement, additional surgeries, and emotional toll suffered by breast cancer reconstruction patients represent compelling cases that our attorneys handle with the sensitivity and urgency they deserve.
How long will my breast mesh lawsuit take?
The breast mesh litigation is at an early stage, and timeline for resolution will depend significantly on how the litigation develops — including whether cases are consolidated into a Multi-District Litigation (MDL) and how quickly bellwether trials occur. Based on comparable medical device litigation including BD’s own hernia mesh cases, the process from initial case filing to resolution typically ranges from two to five years, though settlements can sometimes occur earlier. Our attorneys will keep you informed and involved at every stage.
Can I still file a lawsuit if I don't remember the name of the mesh product?
Yes. Most women who were injured by GalaFLEX or Phasix do not know the exact product name. Our team has extensive experience helping clients obtain and review their operative records to identify specific products. If you had breast surgery between 2015 and today and experienced any qualifying complications, do not let uncertainty about the product name stop you from calling us. Identifying the product is part of what we do.