Breast Mesh Lawsuit

Plaintiffs claim lack of adequate warning, off-label use in breast surgery, lack of testing, and serious complications. These are allegations. Liability depends on the specific facts of each case.

Another important aspect of these claims is how these products are regulated. The FDA has stated it is aware of an increase in the usage of surgical mesh during breast surgery. But the FDA has not concluded that surgical mesh is safe and effective during this type of surgery, and no surgical mesh products have received clearance or approval for breast surgery.

Litigation has already begun. According to public Rhode Island court records, a personal injury lawsuit entitled Katherine Jamfar v. Davol, Inc. et al. was initiated in Providence/Bristol County Superior Court on April 28, 2026.

The defendants listed include Becton, Dickinson and Company, C.R. Bard, Inc., Davol, Inc., Galatea Surgical, Inc., and Tepha, Inc.

A second personal injury case, Laura Shrock-Popson v. Davol, Inc. et al., was also filed in the same court on April 28, 2026.

These are allegations, and none of the named companies has been found at fault.

Eligibility may be determined based on the facts of each individual’s case. It may depend on the type of procedure performed. It also depends on the products used.

Other factors include severity of injury, documentation, and applicable statute of limitations.

Breast mesh, which can be made of biological or synthetic materials, may be used during a breast procedure to provide structural support to tissues and implants. The term may refer to several types of materials used in different breast procedures.

How Breast Mesh Is Used in Breast Surgery

Mesh can be used as an implant support, as well as tissue reinforcement, pocket support, and lift/revision support. A 2025 study examined the literature about the application of synthetic mesh in the role of soft-tissue support in different breast surgeries, such as mastopexy, mammoplasty, augmentation, and reconstruction. The study also highlighted that using ADM and synthetic mesh in breast surgery is off-label according to the FDA.

Internal Bra Surgery and Mesh Support

There is a surgical procedure called an internal bra, where mesh-like material is used to build a scaffold for supporting breast tissues. Different materials are used, such as GalaFLEX and acellular dermal matrix, for example. This kind of surgery is usually performed along with breast lift/augmentation procedures, but not as a replacement for bras.

Biologic Mesh vs. Synthetic Mesh

There are two basic types. Biologics are made from human or animal tissue, while synthetic meshes are polymer-based. Their behavior in the body may differ and may be relevant to the type of complication reported.

Absorbable vs. Non-Absorbable Breast Mesh

Some of them dissolve after time, while some stay there or become integrated permanently. Some earlier internal-bra procedures reportedly used Gore-Tex mesh, which may affect mammographic imaging. GalaFLEX is an absorbable scaffold that may be placed in breast soft tissue for support.

The claims are based on certain allegations and are not proven facts. These are the allegations raised by the plaintiffs in general terms.

Alleged Failure to Warn Patients and Doctors

One allegation is the lack of breast-specific warnings about risks for patients and doctors before mesh insertion.

Alleged Off-Label Use in Breast Surgery

Another allegation is the use of mesh cleared only for general soft tissue reinforcement and not for breast procedures.

Alleged Lack of Breast-Specific Safety Testing

The plaintiffs also argue that the manufacturers have not performed adequate testing regarding the behavior of the mesh in the breast tissue.

Marketing and Manufacturer Conduct Under Review

Marketing, selling, and labeling could also be evaluated. Communication strategies used by manufacturers with surgeons may also be reviewed.

This would look at whether there are any legal problems. These are allegations that have not been proven in court.

The FDA status of the products in question can be misunderstood. Approval for one usage does not necessarily mean an approval for breast surgery.

Has the FDA Approved Surgical Mesh for Breast Surgery?

No. There has been no approval or clearance of surgical mesh for breast surgery by the FDA. According to the FDA, the safety and effectiveness of surgical mesh in breast surgery have not been determined. This includes augmentation and reconstruction procedures.

FDA Labeling Updates for BD Mesh Products

BD mesh devices like Phasix Mesh and GalaFLEX Scaffold are marketed for repairing soft tissues. Surgeons may use these mesh materials in reconstruction and lift operations.

According to MedTech Dive, BD issued labeling changes in 2023 for certain Phasix and GalaFLEX products. A warning statement on the GalaFLEX LITE product label states the device has not been evaluated for the purposes of breast reconstructive procedures.

According to the article, there are no surgical mesh products that have FDA clearance or approval for use in breast surgery.

FDA Safety Concerns About ADM Products

The FDA has previously pointed out that there could be different complication rates associated with some of the ADM products. This is one of the reasons why testing of breast-specific devices is such a repeated issue.

510(k) Clearance vs. FDA Approval

A 510(k) clearance means that a device is substantially equivalent to a device already available on the market. This does not mean the FDA has approved the device for breast surgery.

These products are listed under investigations but are not necessarily defective. Investigations may involve BD mesh products such as Phasix Mesh, Phasix ST Mesh, Phasix Plug and Patch, GalaFLEX Lite Scaffold, GalaFLEX Scaffold, GalaFLEX 3D Scaffold, and GalaFLEX 3DR Scaffold.

Surgical mesh products from other manufacturers may also be included. The FDA reports that it knows of increasing use of surgical mesh in breast surgeries but it has not confirmed the safety and effectiveness of surgical mesh for such uses.

GalaFLEX Breast Mesh

GalaFLEX is a synthetic P4HB scaffold implicated in internal bra and breast support investigations.

Phasix Mesh

Phasix is a BD/C.R. Bard P4HB mesh that has been cleared for soft tissue reinforcement.

DuraSorb Monofilament Mesh

DuraSorb is a synthetic absorbable mesh said to be used in breast reconstruction and internal support.

AlloDerm Regenerative Tissue Matrix

AlloDerm is a human ADM used for breast reconstruction and implant support.

AlloMax Surgical Graft

AlloMax is an ADM product mentioned by the FDA in connection with complication rates.

FlexHD Acellular Dermal Matrix

FlexHD is an ADM product mentioned by the FDA in safety communications.

Strattice Reconstructive Tissue Matrix

Strattice is a porcine ADM that is used in reconstructive procedures.

SurgiMend Breast Mesh

SurgiMend is a biologic matrix used in some reconstructive breast procedures.

The names used below for the companies are neutral in nature since they refer to the company as a manufacturer or seller of a product under investigation. Being named does not imply any form of fault on their part.

Becton, Dickinson and Company / C.R. Bard / Davol

These are the related companies involved in the cases of Phasix and GalaFLEX, as well as breast mesh in general.

Galatea Surgical

This company is associated with the GalaFLEX line of products.

Integra LifeSciences

This company is associated with DuraSorb, as well as other breast mesh investigations.

Allergan / LifeCell / AbbVie

These are the related companies associated with the AlloDerm and Strattice product lines.

MTF Biologics

This company is associated with FlexHD.

Breast mesh problems may overlap with breast surgery in general. This means causation has to be determined for each patient individually.

The information that follows includes reported frequencies and symptoms. They do not imply causation in any individual injury.

Infection and Abscess Formation

Infection and abscesses may present with redness, fever, drainage, and swelling and may require antibiotics, hospitalization, or removal.

A 2025 review reported infection as the most common complication in the literature reviewed. The infection or abscess incidence was 2.36%. The authors have emphasized that there is insufficient data to claim any advantage in the aesthetic results of using the mesh.

Cleveland Clinic describes an abscess as a collection of pus. It can develop in various parts of the body after bacterial infection.

When left untreated, an abscess may grow or rupture. It may also cause pain and spread the infection.

Seroma and Chronic Fluid Buildup

The symptoms may be swelling, fluid accumulation, drainage, and repeat treatment. According to the same 2025 review, the incidence of seroma is 5.04%.

According to the Cleveland Clinic, a seroma is a collection of fluid that develops under the skin mostly as a result of surgical procedures. While usually not harmful, some seromas may become problematic during the healing process.

Hematoma and Postoperative Bleeding

It may be characterized by pain and a collection of blood. Bruising, pressure, and at times surgical evacuation may also occur. The 2025 review revealed that the pooled rate of hematoma was 1.34%.

Cleveland Clinic defines a hematoma as a collection of blood in the body. It fails to drain outside. This causes pain and swelling due to the pressure of the accumulated blood in the body tissues.

Delayed Wound Healing

Symptoms may include open wounds, slow healing, continuous drainage, and a need for prolonged wound care.

Tissue Necrosis

Necrosis is defined as tissue death. It may present through darkening of the skin.

Symptoms also include the need for debridement, implant exposure or removal. According to Breastcancer.org, necrosis occurs due to poor healing of breast skin with inadequate supply of blood.

In severe cases, tissue necrosis may be associated with serious infection. Necrotizing soft-tissue infection is a distinct medical emergency involving bacterial infection of the skin or underlying tissues. It is caused by bacterial invasion of the skin or underlying tissues.

Urgent treatment is needed to avoid complications. These include tissue destruction, amputation, kidney failure and even death.

Capsular Contracture

It is defined by hardness, tightening, pain, distortion, or dislocation of the implant. According to the FDA, capsular contracture is scar tissue that develops around the breast implants and squeezes them.

This causes hardness and tightness. It can be painful and, in some cases, require repeat surgery.

According to the American Society of Plastic Surgeons, capsular contracture takes place when scar tissue around an implant becomes hard and tightened. It influences the appearance of the breast. In extreme cases, it causes pain or a need for aggressive treatment.

Chronic Pain and Nerve Symptoms

It includes pain in the chest wall, pulling sensation, numbness, burning or restricted mobility. According to a systematic review, nerve injury following breast augmentation was reported in the analyzed research articles.

However, the data were insufficient to establish the incidence of nerve injury in mastopexy procedures.

According to WebMD, possible symptoms of nerve damage are pain, sensitivity, numbness, tingling, pricking, and burning sensations. It may decrease quality of life. Sometimes it may not fully resolve.

Mesh Migration or Detachment

Symptoms might include change in support, asymmetry, palpable bands under the skin, or implant displacement.

Mesh Erosion or Extrusion

Symptoms might include exposed mesh or implant. Skin thinning, unhealed wounds, or a need to remove the implant may also occur.

Implant Malposition or Breast Deformity

Breastcancer.org indicates that breast implants can be displaced from their position with time. It defines this as one of the post-reconstruction complications. Symptoms can include asymmetry, bottoming out, rippling, contour problems, or deformity.

Implant Loss or Reconstruction Failure

Implant loss, reconstruction failure, infections, necrosis, or repeated surgeries can be included in this category.

A 2021 article described implant loss as a severe complication and reported an 11.8% rate in the population studied. However, this data was collected in only two centers. So it might not be generalizable to other populations.

Revision Surgery or Mesh Removal

Corrective surgery may be an indicator of severity. It matters in the assessment of the case from a legal perspective.

According to the FDA, complications linked to breast implants may involve additional surgeries. These may or may not involve removal of the implant.

Also, there is no assurance of a satisfactory cosmetic result after additional surgery.

Medical help comes first. If you have urgent symptoms, contact a physician before taking any legal steps.

Signs of Infection After Breast Mesh Surgery

Seek advice from a physician if these symptoms occur. These include fever, growing redness, warmth, discharge, increased pain, or feeling very ill.

Signs of Mesh Failure or Implant Problems

Be attentive to changes in asymmetry, displacement of implants, and firmness. Watch for swelling or signs of change in the wound site.

Symptoms That May Require Revision Surgery

Persisting infection, exposure of the mesh, loss of an implant, necrosis, or disfigurement may indicate a need for revision surgery. A doctor is well placed to decide this question.

Claims usually involve significant injuries that required treatment or revision.

Implant Rupture

According to the FDA, implant rupture means a tear or damage in the outer shell of the implant. The FDA states that silicone breast implants can rupture at any time after surgery. The possibility increases the longer the implant remains in place.

Furthermore, Breastcancer.org indicates that symptoms might include any changes in shape, size, pain, or firmness. Swelling and capsular contracture may also appear. A doctor may recommend removal of a ruptured implant based on the patient’s condition.

Infection Requiring Medical Treatment

It could require antibiotics, drainage, hospitalization, or removal.

Mesh Removal or Implant Removal

Explant/removal is a significant factual indicator, but it does not automatically qualify the case. The specific facts determine each case.

Corrective or Revision Surgery

It includes surgical correction of pain, deformity, infection, scarring, and failure According to Yale Medicine, revision surgery is “a redo surgery”.

Doctors are also advised to carefully evaluate patients before conducting such operations. Symptoms of the injury may be subtle. Revisions may be more complicated than the original procedure.

Permanent Scarring or Disfigurement

Visible scars, deformities or disfigurement may be included.

Chronic Pain or Long-Term Symptoms

Pain, stiffness, numbness, or restricted movement may occur on a chronic basis. Other symptoms may too. These may be relevant to a claim review.

Reconstruction Failure

This could include a failed implant reconstruction surgery or changing the procedure used.

Several records may help identify whether mesh was used and which product was involved.

Requesting Your Operative Report

The operative report is often a useful first step to take. It will usually contain information regarding your procedure and the implants used.

Looking for Device Stickers, UDI Numbers, and Lot Numbers

Information may be contained on product stickers. It may also be on the unique device identifier, catalog number and lot number.

The FDA states that the unique device identification system helps identify devices. It tracks them from manufacturing to use by patients. The device identifier may help identify the labeler and a specific model or version.

Reviewing Pathology, Imaging, and Explant Records

The removal records may reveal the type of mesh. They may also reveal the complications. This shows the importance of explant and pathology records.

What to Do If You Do Not Know the Mesh Brand

You do not need prior knowledge of the manufacturer to seek a case review.

The FDA reveals that a device identifier may reveal the labeler and specific model. The device database of the FDA does not provide any information related to the user of the device or patient-specific data. A lawyer may be able to help identify the product through medical records.

These records are what link together the product, symptoms, treatment and injuries. The FDA states that unique device identifiers help identify devices and support tracking.

The UDI system supports tracking from manufacturing through distribution and patient use. According to the FDA, the device information includes labeler, model, lot/batch number, serial number, and dates if such information is provided.

Surgical and Operative Records

They reveal the date of original surgery, type of procedure and product information.

Medical Records Showing Complications

These records may include diagnosis notes, follow-ups, infections, necrosis, pain, and deformity documentation.

Imaging, Photos, and Wound Documentation

Ultrasound, MRI, CT scans, wound photos, and visible changes could help support the case.

Records of Revision Surgery or Mesh Removal

Notes from explant surgery can be helpful because they usually mention the mesh and injury.

Medical Bills and Lost Wage Documentation

Save all bills, travel expenses, lost earnings records, and future-care estimates.

Timeline of Symptoms and Treatments

A date-based timeline documenting symptoms and treatments can help make your case clearer.

These are general guidelines and not legal advice. Each case is unique.

Step 1: Get Medical Care for Complications

It is important to get medical care for complications before focusing on a lawsuit.

Step 2: Request Your Medical Records

Request operative, follow-up, imaging, billings, and revision surgery records.

Step 3: Identify the Mesh Product and Manufacturer

Use these documents to identify the manufacturer of the breast mesh product.

Step 4: Speak With a Breast Mesh Lawsuit Lawyer

An attorney can evaluate your eligibility, potential causation, deadlines, and product information.

Step 5: File Before the Statute of Limitations Expires

These dates vary depending on the specific state and the facts of your case. Speaking with an attorney promptly may help.

Damages may be available only if supported by the facts and applicable law. None of the information provided below is guaranteed compensation.

Medical Bills and Revision Surgery Costs

This might cover medical bills and costs related to breast mesh revision surgery.

Future Medical Treatment

Some lawsuits have future medical procedures as one of the aspects.

Lost Wages or Reduced Earning Capacity

It may include lost income and reduced ability to earn going forward.

Pain and Suffering

It involves physical pain and the limitations imposed by it.

Emotional Distress

Some lawsuits also contain anxiety and emotional distress linked to the injury.

Scarring, Disfigurement, and Loss of Quality of Life

This pertains to the lasting visual and functional effect on one’s life.

There is no guarantee that one gets paid. There is also no predetermined value for these cases.

It may be helpful to take caution on any specific value figures. These could only be an estimate or marketing material.

Have There Been Breast Mesh Settlements Yet?

This area is yet to develop. No broad breast mesh settlement program has been confirmed as of this page’s publication date.

Factors That May Affect Settlement Value

The injury’s seriousness, the number of operations, and the proof of the case can affect its value. So can causation, expenses, and the statute of limitations.

Why Prior Hernia Mesh or Vaginal Mesh Settlements May Not Predict Breast Mesh Results

Cases of other mesh types are simply a reference. They cannot be taken as a predictor of breast mesh settlements. The product and the case’s facts are different.

It may be helpful to differentiate recalls from a warning. Or from the updating of labels or from litigation.

Breast Mesh Recalls vs. FDA Labeling Updates

A labeling update means something on its own, even without a recall. It could mean that new or revised information is being communicated about the product.

Why Lack of Recall Does Not Automatically Mean Lack of Claim

Legal claims could be focused on warnings, testing, marketing, or injury specifics. So a lack of recall does not necessarily mean the case cannot proceed.

A breast mesh lawyer may help with eligibility review, records, deadlines, and case preparation.

Reviewing Eligibility

They can evaluate whether your surgery, injuries, device, and deadlines meet eligibility requirements for filing a claim.

Obtaining Medical Records

They can gather and organize your medical records for you.

Identifying the Product and Manufacturer

They may be able to identify the breast mesh device manufacturer using operative reports and device information.

Filing the Claim Before Legal Deadlines

They can assess statutory deadlines. This may help avoid missing applicable deadlines.

Pursuing Settlement or Trial Compensation

A case may resolve through settlement or proceed to trial, but outcomes vary case by case.

Have you been experiencing complications after surgery involving a breast mesh device? Legal options may be available. An attorney can review the facts and explain what legal options may be available.

A free consultation can help you decide what to do next. You can Get a Free Consultation for a Breast Mesh Lawsuit to discuss what has taken place. There is no attorney-client relationship before an agreement is signed.

Contingency Fee Disclaimer: Clients may be responsible for court costs as provided in the fee agreement and permitted by law. In some cases, a court may order clients to pay opposing parties’ fees as permitted by law. This applies if no recovery is obtained.