GalaFLEX Lawsuit

Claims are being investigated and attorneys are reviewing more potential filings. Settlements for these claims are not guaranteed, and not every claimed injury is related to GalaFLEX’s product.

At least two personal injury lawsuits involving GalaFLEX have been filed in Rhode Island state court.

• Katherine Jamfar filed a personal injury case in Providence/Bristol County Superior Court on April 28, 2026, the public docket shows. 
• Laura Shrock-Popson filed her own case in the same court that day, according to Rhode Island court records. 

Both name Befcton Dickinson, Bard, Davol, Galatea Surgical, and Tepha as defendants.

The FDA says it is aware surgeons are using mesh in breast surgery more often. It has never determined that mesh is safe and effective in that setting, though.

You may qualify for a GalaFLEX lawsuit if you experienced serious complications after GalaFLEX mesh was used during breast surgery. Qualification does not guarantee a recovery. The strength of a potential case depends on the specific facts and medical records.

GalaFLEX is a synthetic surgical scaffold used to reinforce soft tissue. It is also sometimes used as an internal breast support. The product gradually absorbs in the body over approximately 18 to 24 months.

GalaFLEX, GalaFLEX Lite, GalaFLEX 3D, and GalaFLEX 3DR

The mesh has several versions. An FDA letter about Becton, Dickinson and Company (BD) mesh products lists them by name, including the following:

• GalaFLEX Scaffold
• GalaFLEX Lite Scaffold
• GalaFLEX 3D Scaffold
• GalaFLEX 3DR Scaffold

The FDA has also said it knows surgical mesh in breast surgery is being used more often. But it has not determined if it’s safe or effective for breast augmentation or reconstruction.

GalaFLEX as a Bioresorbable P4HB Surgical Scaffold

P4HB is the material that gradually absorbs as tissue grows into the surgical scaffold. 

GalaFLEX vs. Phasix Mesh

GalaFLEX and Phasix Mesh are both surgical scaffold products. They may both be reviewed in breast mesh investigations. The exact product used in your procedure matters, as it may impact how attorneys review your case.

Surgeons may use GalaFLEX to reinforce weak tissue, support an implant, or help the breast hold its position. A 2025 review found synthetic mesh used for soft-tissue support in mastopexy, mammoplasty, augmentation, and reconstruction. The same review described mesh use in breast surgery as off-label.

Internal Bra Breast Surgery

An internal bra is a support method. It is not a separate implant or body part. 

Breast Reconstruction After Mastectomy

Mesh may be used after cancer-related surgery to support implants or tissue expanders.

Breast Augmentation

Breast augmentation may sometimes lead to thin or stretched tissue. In these cases, mesh may be used to provide implant support.

Breast Lift or Mastopexy

Mesh may be used to support the lower breast and reduce recurrent sagging after a breast lift or mastopexy. 

Breast Reduction Surgery

Surgeons may use mesh as support after removing tissue in a breast reduction surgery. This depends on the surgeon’s judgment and varies case by case. 

Revision Surgery or Implant Replacement

Mesh may be used after implant issues, malposition, or weakened tissue after revision surgery or implant replacement.

The investigations focus on allegations involving inadequate warnings, lack of breast-specific safety data, complications, and marketing. 

Alleged Failure to Warn About Breast Mesh Risks

Lawsuits may allege patients or doctors were not clearly warned about the serious risks of breast mesh. 

Alleged Off-Label Use in Breast Procedures

Some GalaFLEX lawsuits may allege the product was used off-label in procedures. Off-label use in medicine is legal. It is simply a factor that attorneys may use in cases to raise questions around testing and warnings. 

Alleged Lack of Adequate Breast-Specific Safety Data

Cases may allege there was a lack of breast-specific safety data about the mesh before it was used in procedures. 

Manufacturer Allegations in GalaFLEX Claims

Plaintiffs may allege defective design, inadequate warnings, or improper marketing. 

The FDA has issued multiple statements about the use of mesh in breast surgery. 

FDA Position on Surgical Mesh for Breast Reconstruction and Augmentation

The FDA has stated that surgical mesh has not been determined safe and effective for breast surgery, including augmentation and reconstruction. No mesh product holds FDA clearance or approval for those procedures, the agency says.

November 2023 FDA Letter to Health Care Providers

BD updated the labels for multiple Phasix and GalaFLEX products, MedTech Dive reported. The updated GalaFLEX LITE warning states the device “has not been studied for use in breast reconstructive surgeries.”

The same article said no mesh products are cleared or approved by the FDA for breast surgery.

March 2021 FDA Safety Communication on ADM Products

In March 2021, the FDA released a safety communication about acellular dermal matrix products, or ADM. ADM products are biologic materials made from donated tissue. GalaFLEX is synthetic, but both are used as support materials in breast reconstruction.

FDA MAUDE Reports Involving Breast Mesh Complications

MAUDE is an FDA database that collects reports of medical device problems. A report shows that an event was reported.

The complications below have been reported after breast mesh procedures. They still require a review of your medical records. Whether the product caused them depends on the specific case.

Infection or Abscess

Infection can appear soon after surgery or months later. Treatment may include antibiotics, drainage, or another surgery.

A 2025 review reported a combined infection and abscess rate of 2.36% across the included mesh studies. Infection was the most common complication in the studies it looked at. But the authors said the data was limited and did not show better cosmetic results with mesh.

An untreated infection can turn into an abscess. The Cleveland Clinic describes an abscess as a pocket of pus, usually caused by a bacterial infection. It can grow, burst, become very painful, and spread the infection.

Seroma or Chronic Fluid Buildup

A seroma is a pocket of fluid that builds up under the skin, most often after surgery, the Cleveland Clinicsays.

The same 2025 review reported a pooled seroma rate of 5.04% across the included mesh studies. Persistent fluid buildup may need draining or a drain left in place for a while.

Hematoma

A hematoma is blood that collects inside the body when it cannot drain out, the Cleveland Clinic explains. The pooled blood can push on nearby tissue and cause pain and swelling.

Hematomas may need monitoring, drainage, or surgery. The 2025 review reported a pooled hematoma rate of 1.34%.

Chronic Pain or Nerve Damage

Some women report burning, numbness, extra sensitivity, or persistent breast pain.

A separate systematic review found reports of nerve injury after breast augmentation. It did not have enough data to set nerve injury rates for mastopexy. So the risk may depend on the procedure.

WebMD lists pain, sensitivity, numbness, tingling, prickling, and burning as nerve damage symptoms. It says nerve damage can seriously affect quality of life and may not always be fully curable.

Capsular Contracture

Capsular contracture is scar tissue that forms around a breast implant and squeezes it, the FDA says. It can cause hardening and tightness around one or both implants. It may be painful, and severe cases may need another operation.

The American Society of Plastic Surgeons explains that scar tissue can become unusually hard and tighten. This can affect how the breast looks. More severe cases can bring pain, tenderness, or more aggressive surgical treatment.

Mesh Migration, Detachment, or Displacement

Mesh can shift, detach, or move out of position. When that happens, it may stop working as support. Sometimes the problem is only found during revision surgery.

Implant Malposition or Asymmetry

Breast implants can shift out of the correct position over time, Breastcancer.org explains. It lists displacement as a possible problem after mastectomy reconstruction.

Related problems include bottoming out, uneven breasts, and contour changes.

Implant Rupture

The FDA describes rupture as a tear or hole in the implant’s outer shell. Silicone implants can rupture at any time, the agency states. The odds rise the longer an implant stays in place.

Signs may include a change in breast shape or size, pain, firmness, or swelling, according to Breastcancer.org. The same source says a ruptured implant should come out if the patient is healthy enough for surgery. That means one more operation on the timeline.

Skin Necrosis or Tissue Erosion

Necrosis means tissue death. Breastcancer.orgexplains that breast skin can wither, scab, and die when it stops getting enough blood flow after reconstruction.

The most serious form is a necrotizing soft tissue infection. Johns Hopkins Medicine calls it a life-threatening condition that needs treatment right away. Untreated cases can destroy tissue and may lead to amputation, kidney failure, or death.

Delayed Wound Healing or Wound Breakdown

Some wounds reopen after surgery. Doctors call this dehiscence. An open wound may need weeks of care, including dressing changes and wound clinic visits.

Mesh Exposure or Implant Exposure

Thin or broken skin can leave the mesh or an implant exposed. Exposure may require prompt evaluation, revision surgery, removal, or treatment for an infection.

Reconstructive Failure

A 2021 study called implant loss the most severe complication of implant-based breast reconstruction. It measured an 11.8% incidence in its study population. The authors added a caveat, though, since data from two medical centers may not describe every patient’s risk.

Revision Surgery, Explant Surgery, or Implant Removal

More operations are a known outcome of breast implant complications, the FDA says, with or without removal of the device. It offers no assurance of a satisfying cosmetic result the second time.

Yale Medicine describes revision surgery as a “redo” surgery. These procedures are often more complex than the original procedure. Symptoms can be subtle, so doctors should evaluate patients carefully before recommending one.

Additional surgery is often an important part of a claim review.

A normal recovery by itself is usually not enough for a claim. A potential GalaFLEX internal bra claim may require serious complications documented in medical records.

Normal Recovery vs. Serious Post-Surgical Complications

Soreness, swelling, and bruising are normal after surgery. These usually fade within a few weeks.

Problems like persistent infection, ongoing pain, wound failure, or repeat surgery are different. These may support a legal claim.

Why Product Identification Matters

A product-specific claim generally needs confirmation that GalaFLEX was actually used. Operative records, device stickers, UDI information, and billing data can confirm the product.

The FDA explains that unique device identifiers are used to identify devices from manufacturing through patient use. A UDI may identify the labeler, the device model, and, when included, the lot or batch number and serial number.

Why the Timing of Symptoms Matters

Attorneys compare the date of the surgery, the first symptoms, the diagnosis, and the treatment. The timing helps show how these events may be connected.

Why Revision or Explant Surgery Can Strengthen a Claim Review

Revision or explant surgery can provide direct medical findings. The surgeon documents what was found, and pathology can confirm it. This can make the claim documentation stronger.

Strong claims are built on documentation. It should cover the product, the timeline, the complications, the treatment, and the losses. A lawyer can help you request any records you do not have.

Operative Reports and Surgeon Notes

The operative report shows the procedure date, the technique, the mesh placement, and the surgeon’s reasoning. It is one of the most important records in a claim.

Implant Logs, Device Stickers, and UDI Information

Hospitals generally log devices they implant. The paperwork from your surgery may include:

• The product label and device stickers
• Lot and catalog numbers
• The hospital’s implant record sheet

These records connect to the FDA’s UDI system. A device identifier can confirm the maker and the exact model of the device used in your surgery.

Medical Records Showing Symptoms and Follow-Up Care

Office notes document what happened between operations. Notes about pain, infection, swelling, wound issues, or changes in breast shape all become part of the claim.

Imaging, Lab Results, and Culture Reports

An ultrasound or MRI can show fluid buildup and implant position. A culture report can identify the bacteria behind a suspected infection.

Revision Surgery or Mesh Removal Records

Records from a revision or removal may include explant findings, pathology results, operative notes, and implant replacement details. These records may document the complication clearly.

Preserved Mesh or Explanted Material

Removed mesh can sometimes be preserved. If you have an explant scheduled, ask beforehand whether the material can be kept. Your attorney and your medical team can guide you on this.

Medical Bills, Insurance Records, and Wage Loss Records

Medical bills, insurance records, and wage records document the financial losses. They cover the treatment, the recovery, and the missed work.

Personal Timeline of Symptoms and Treatment

A written timeline helps your attorney understand the case. It should cover the surgery, the symptoms, the diagnosis, and any later procedures.

Damages in a GalaFLEX breast mesh lawsuit may include financial losses and personal losses. Each category depends on the evidence in your case.

Medical Expenses

You may be able to seek the documented costs of care, including:

• Hospital care
• Doctor visits
• Antibiotics
• Imaging
• Wound care
• Later procedures

Future Revision Surgery or Implant Removal Costs

Future care may also be included. This applies when the care is medically supported or reasonably expected, like a planned revision or removal.

Lost Wages and Reduced Earning Capacity

Lost wages can cover missed work and reduced hours. Lasting limits on the work you can do may also be part of a claim.

Pain and Suffering

Pain and suffering may cover physical pain, chronic symptoms, and the burden of recovery. These damages depend on what the records support.

Emotional Distress and Body Image Harm

Anxiety, distress, embarrassment, or trauma can follow these complications. These harms may also be included in a claim.

Scarring, Tissue Loss, or Disfigurement

Visible changes may count as damages too. This includes scarring, tissue damage, asymmetry, or permanent cosmetic harm.

Loss of Enjoyment of Life

Complications can limit normal activities. That can include exercise, intimacy, clothing comfort, or confidence. A claim may count these limits as losses.

There is no set value for a GalaFLEX mesh lawsuit. The value depends on the facts of each case, and no settlement amount can be promised.

Current Status of GalaFLEX Settlement Amounts

Public settlement benchmarks may not be available yet. These cases are still developing, so this can change.

Factors That May Affect Case Value

Case value may depend on the following factors:

• How severe the complications were
• How many surgeries and treatments followed
• The strength of the medical records
• Causation opinions from qualified professionals
• Documented financial losses
• The state or court where the case is filed
• The evidence the defendants present

Why Severe Complications and Multiple Surgeries May Matter

Repeat surgeries often increase the documented medical costs. They can also increase personal harm, since each operation adds more recovery time.

Deadlines come from state law, and they are strict. How long you have to file a lawsuit against GalaFLEX manufacturers depends on your state and when the injury came to light.

Statutes of Limitations

Each state writes its own statute of limitations. The clock may start at the injury, at its discovery, or at another date set by state law. Missing the deadline usually ends a claim.

Discovery Rules for Delayed Breast Mesh Complications

Mesh problems sometimes surface years after the original surgery. Discovery rules exist for that situation and can sometimes extend the time to file. The analysis turns technical quickly, though, so only an attorney applying your state’s law can assess your deadline.

Why You Should Request Medical Records Early

Requesting your medical records early helps. The records can confirm the product, the dates, and the complications. They also help an attorney assess how urgent your filing deadline may be.

A case review usually follows four steps. None of them commits you to anything.

Step 1: Confirm the Breast Procedure and Mesh Product

The first step confirms the surgery type, the date, the surgeon, the facility, and the product records. People considering claims against GalaFLEX manufacturers generally need this confirmed first.

Step 2: Review Complications and Treatment History

Next, the complications and the treatment history are reviewed. This includes symptoms, diagnoses, medications, follow-up visits, and surgeries.

Step 3: Evaluate Records, Damages, and Filing Deadlines

Attorneys then look at the records, the damages, and the filing deadlines together. This helps them decide if the claim may be worth pursuing.

Step 4: Decide Whether to Move Forward With a Claim

The final decision is yours. After the review, you choose whether to move forward with a claim. Nothing is filed unless you agree.

If you have documented complications after GalaFLEX or internal bra breast surgery, you can request a confidential legal review. The review can show whether your records may support a claim. Get a Free Consultation for a Breast Mesh Lawsuit to discuss the product, your records, and your deadlines.