Breast Mesh Complications

Surgeons may use mesh to support tissue, implants, or the results of a reconstruction.

Breast Reconstruction After Mastectomy

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

Mesh may help control implant movement in reconstruction, but different products may have varying risks, costs, and complications. A 2025 systematic review of VICRYL mesh in breast reconstruction reported complications including the following:

• Reconstructive failure
• Seroma
• Infection
• Hematoma
• Skin necrosis

Breast Augmentation, Lift, Reduction, or Revision Surgery

Mesh is also used in some cosmetic and revision procedures for structure. A 2025 review looked at synthetic mesh used for soft-tissue support in mastopexy, mammoplasty, augmentation, and reconstruction. It reported that the FDA considers the use of ADM or synthetic mesh in breast surgery off-label.

Implant Support, Sagging, Asymmetry, and Tissue Reinforcement

The intended goals of using breast mesh are for implant stability, to improve pocket control, correct sagging, and support weak tissue.

Complications may involve the device design or the way tissue responds. Infection, surgical technique, and patient health factors can also play a part.

Mesh Used in Breast Tissue

Some mesh products were originally developed for use in abdominal surgery. Breast tissue moves and stretches differently, which may affect how those products perform when used in breast procedures. Breast mesh lawsuits may involve people who received mesh or scaffold products during breast surgery, including augmentation or reconstruction. The FDA says it is aware of increased surgical mesh use in breast surgery.

But it has not determined that surgical mesh is safe and effective for that use. No surgical mesh products are cleared or approved by the FDA for breast surgery.

Off-Label Use and FDA Clearance Concerns

The concerns involve mesh that was not specifically cleared or approved for breast surgery. Off-label use in medicine can be legal. It is a factor that attorneys may use to raise questions about testing and warnings.

The FDA has stated that mesh products have not been determined to be safe and effective for breast surgery. That includes augmentation and reconstruction. It has said no mesh products are cleared or approved for that use, even though use in these procedures has increased.

Foreign Body Reaction, Poor Integration, and Inflammation

The body may react to mesh with inflammation or scar tissue. The mesh may also be rejected by the body and fail to integrate.

Mesh Degradation, Migration, or Detachment

Mesh may reportedly break down, loosen, shift, curl, or fail to support the implant pocket.

Biofilm and Delayed Infection Risk

Bacteria may attach to the surface of the mesh. This can form a layer known as biofilm, where infections can show up later or be more difficult to treat.

The complications below have been reported after procedures that used breast mesh. Each requires a medical evaluation and its own review.

Infection or Abscess

An infection or abscess can lead to redness, warmth, fever, pus, drainage, and potential removal. It may require antibiotics in some cases too.

Cleveland Clinic describes an abscess as a pocket of pus that can form almost anywhere in or on the body. A bacterial infection is often the reason. An untreated abscess can grow, burst, and become very painful, and the infection can spread.

Chronic Breast Pain or Nerve Damage

Chronic breast pain and nerve damage may result in burning, shooting pains, numbness, tingling, hypersensitivity, and pain that radiates to the chest or arms.

Possible complications after breast surgery may include nerve injury, sensation changes, numbness, or chronic pain. A systematic review found reports of nerve injury after breast augmentation in the studies it covered. The data wasn’t enough to determine nerve injury rates for mastopexy. So the risk may depend more on the procedure and the facts.

Seroma, Hematoma, or Fluid Buildup

Fluid or blood can collect near the mesh after surgery. This may cause swelling, pressure, and a heavy feeling. A drainage procedure may be used to remove the fluid.

A seroma is a pocket of fluid that builds up under the skin, most often after surgery, according to Cleveland Clinic. While most seromas aren’t considered dangerous, they can still cause issues when healing.

A hematoma is described by the Cleveland Clinic as a closed wound where blood collects inside the body because it cannot flow or drain out. Pooled blood can push on the surrounding tissue and bring pain and swelling.

Capsular Contracture or Breast Hardening

Scar tissue around the implant can lead to painful hardening, tightness, and distortion.

The American Society of Plastic Surgeons reports that capsular contracture is the result of scar tissue around an implant becoming unusually hard, causing it to tighten. This can impact the way the breast looks and in some cases, it can lead to pain or tenderness and require further surgical treatment.

Mesh Migration, Implant Malposition, or Implant Shifting

Mesh or an implant may move out of position. This can potentially result in asymmetry, bottoming out, rippling, bulging, or instability.

Breastcancer.org says implants can shift out of the correct position over time. It lists displacement as a possible problem after mastectomy reconstruction. Displacement may count as a qualifying complication, depending on the facts and the medical records.

Implant Rupture, Implant Failure, or Implant Loss

Some cases involve a ruptured implant, a failed reconstruction, or removal of the implant. The FDA describes rupture as a tear or hole in the outer shell of a breast implant. It states silicone implants can rupture at any time after surgery, and the chance goes up the longer the implant stays in place.

Skin Necrosis, Wound Healing Problems, or Tissue Breakdown

Some patients report discolored skin or open wounds. Others report exposed material, delayed healing, or tissue death.

Breastcancer.org explains how skin that doesn’t get enough blood flow can wither, scab, and die. This process is known as necrosis. It may count as a qualifying complication for a lawsuit after breast implant surgery.

Scarring, Breast Deformity, or Reconstruction Failure

Visible deformity can happen in some cases. Some patients may also experience loss of support, repeated complications, or failed reconstructive/cosmetic procedures.

Revision Surgery, Mesh Removal, or Explant Surgery

Serious complications may require additional procedures, and some patients need more than one. The FDA states that breast implant complications may require more surgeries, with or without removal of the device. It also notes there is no guarantee of a satisfactory cosmetic outcome after a reoperation.

Yale Medicine describes revision surgery as a redo surgery. It notes doctors should evaluate patients carefully before recommending it, because symptoms can be subtle. Revision surgeries are often more complex than the original procedure.

If you notice the symptoms below, get medical care promptly. This page cannot diagnose the cause. Only a doctor can evaluate your symptoms.

Pain, Burning, Tingling, Numbness, or Sensitivity

Pain, burning, tingling, numbness, or sensitivity may be related to other problems. These may include nerve irritation, inflammation, scar tissue, or mesh issues.

WebMD mentions that nerve damage may result in pain, sensitivity, numbness, prickling, burning, or tingling.

Redness, Warmth, Fever, Drainage, or Recurring Infection

Redness, warmth, fever, drainage, or recurring infection may be signs of infection that need urgent medical attention.

Swelling, Tightness, Fluid Movement, or Breast Heaviness

Swelling, tightness, heaviness in the breasts, and fluid movement may be linked with seroma. Those symptoms may also be connected to inflammation, hematoma, or implant-pocket complications.

Hardening, Asymmetry, Shape Changes, or Bottoming Out

Hardening, asymmetry, changes in shape or bottoming out may be linked with contracture, support failure, shifting, or pocket breakdown.

Skin Breakdown, Open Wounds, or Exposed Mesh

The breakdown of skin, open wounds, or exposed mesh are serious warning signs that need immediate review from a doctor.

Johns Hopkins Medicine describes necrotizing soft tissue infection as a life-threatening condition where bacteria invade the skin or the tissue under it. The condition needs treatment right away. If left untreated, it could destroy tissue and result in kidney failure or amputation, creating a higher risk of death.

Sudden Deflation or Suspected Implant Rupture

Sudden deflation may mean the implant has failed. Imaging or a surgical evaluation may be needed, especially when a silicone rupture is suspected.

A rupture means the outer shell of the implant has a tear or hole, as Breastcancer.org explains. Signs may include changes in breast shape or size. Pain, firmness, swelling, or capsular contracture can also appear.

The site also states a ruptured implant should be removed if the patient is healthy enough for surgery.

Internal bra side effects may appear after cosmetic procedures or reconstructive ones.

Internal Bra Mesh Used for Implant Support or Lift Reinforcement

Surgeons may place internal bra mesh to support an implant or reinforce a lift. Reported failures can affect where the implant sits.

Internal Bra Mesh Used in Cosmetic Surgery

Patients who had an augmentation, a lift, a reduction, or a revision may not realize mesh was used.

When Internal Bra Mesh May Fail

Internal mesh bra side effects may include:

• Pain
• Shifting
• Infection
• Swelling
• Deformity
• The need for removal

Reconstruction patients may carry an added burden when complications happen. The burden can be physical and emotional at the same time.

Mesh Used After Cancer Surgery

Mesh may be placed with tissue expanders or implants after a mastectomy.

Tissue Expander and Implant-Based Reconstruction Complications

Reported problems include infection, fluid buildup, and wound issues. Expander problems and implant-pocket failure are reported as well.

Implant Loss or Reconstruction Failure

Severe complications may end with removal of the implant, and some patients stop reconstruction after that. A 2021 study described implant loss as the most severe complication of implant-based breast reconstruction. It reported an 11.8% incidence, though the data came from only two medical centers and may not apply to all patients.

Emotional and Physical Impact of Failed Reconstruction

Some patients may feel an emotional and physical toll of failed reconstruction.

A product-specific review depends on your medical records. It also depends on identifying the exact device that was used.

GalaFLEX and Phasix Mesh Complications

GalaFLEX and Phasix often come up in internal bra and breast mesh investigations. Reviews may involve BD mesh products such as:

• Phasix Mesh
• Phasix ST Mesh
• Phasix Plug and Patch
• GalaFLEX Lite Scaffold
• GalaFLEX Scaffold
• GalaFLEX 3D Scaffold
• GalaFLEX 3DR Scaffold

Mesh products from other manufacturers may be involved too. The FDA says it is aware of increased mesh use in breast surgery. It has not determined that mesh is safe and effective for that use.

BD sells Phasix Mesh and GalaFLEX Scaffold for soft-tissue repair and reinforcement, and surgeons have used mesh in breast reconstruction and breast lift procedures. MedTech Dive reported that BD updated the labels on multiple Phasix and GalaFLEX products. The warning section for GalaFLEX LITE states the device “has not been studied for use in breast reconstructive surgeries.”

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

Strattice, AlloDerm, FlexHD, and AlloMax Complications

Strattice, AlloDerm, FlexHD, and AlloMax are biologic or ADM products used in reconstruction. Complication concerns have been reported around products in this group as well. Your records can show whether one of them was part of your surgery.

Synthetic vs. Biologic Mesh Complications

Risks of synthetic or biological mesh vary by product, patient, surgery, and study.

Each study below mentions reported complication categories and rates across groups of patients.

Reported Infection, Seroma, and Reoperation Rates

Studies report infections, fluid buildup, and additional surgeries in some patients. A 2025 review found infection was the most commonly reported complication in the studies it covered. It reported a pooled infection and abscess rate of 3.61% where mesh was used as an internal bra.

The same review reported a pooled seroma rate of 5.04%. The data is limited and does not support claims of improved cosmetic results with mesh.

Reported Implant Loss and Reconstruction Failure Rates

Implant loss is a serious outcome that some patients have reported. It’s especially important if it occurred after infection or failed integration.

Comparing Synthetic Mesh With Biologic Mesh

Some research compares outcomes between synthetic mesh and biological mesh. The findings are specific to the studies and can’t be applied universally.

What Research Shows About Breast Mesh Safety

Evidence shows risks that require more evaluation. The 2025 review also reported a pooled hematoma rate of 1.34%.

Qualified surgeons make the decision on whether to remove breast mesh or do revision surgeries.

When Doctors May Recommend Mesh Removal

Doctors may recommend removal for problems such as:

• Ongoing infection
• Ongoing pain
• Fluid buildup
• Exposed mesh
• Shifting
• A failed reconstruction

Mesh Removal, Implant Removal, or Capsulectomy

Mesh removal takes out the mesh, and implant removal takes out the implant. A capsulectomy removes the scar capsule that formed around the implant.

The FDA describes capsular contracture as scar tissue that forms around a breast implant and squeezes it. The condition can bring hardening and tightness around one or both implants. It may be painful, and severe cases sometimes require another operation.

Abscess Drainage, Seroma Drainage, or Pocket Repair

Some cases require drainage or cleaning of the area. Others require a repair or a staged reconstruction.

Implant Replacement or Secondary Reconstruction

Replacing implants or getting secondary reconstruction may not happen until the infection and tissue damage improve.

Tissue Reconstruction or Flap Surgery

Reconstruction with your own tissue may be considered after repeated implant issues.

Recovery After Breast Mesh Removal

Recovery is different for everyone. It depends on any infection, tissue damage, the type of procedure, and the patient’s overall health.

If you suspect a problem, medical care comes first. Records and a legal review can come after that.

Get Medical Care for Ongoing Symptoms

If you’ve experienced ongoing symptoms, prioritize being evaluated by a doctor. Ongoing symptoms that need further evaluation from a doctor may include pain, fever, swelling, wounds, shape changes, or drainage.

Ask What Mesh Product Was Used

Ask your surgeon’s office for the exact brand and manufacturer. Request the lot number and the other device details.

You may need medical or surgical records to confirm the exact product. The FDA explains that a device identifier can identify the labeler and the specific version or model of a device. Its AccessGUDID database does not show who used a device, and it holds no personal patient information.

Request Your Operative Report and Implant Records

The operative report often identifies what was implanted and why. Implant records can do the same.

Save Device Cards, Photos, and Medical Paperwork

Keep device cards, photos, and medical paperwork, ensuring not to alter or throw away potentially relevant materials.

Track Symptoms, Medical Visits, and Revision Recommendations

Keep track of symptoms, medical appointments, medications, procedures, missed work, and recommendations of revisions. This will help provide you with a timeline of events that may be useful in a potential lawsuit.

Avoid Signing Manufacturer Releases Without Legal Review

It may be wise to get a legal review before signing a broad release or settlement paperwork. That includes paperwork that comes from a manufacturer.

A legal review depends on the records, the device identification, and the severity of the injury. Causation is part of the review as well.

Operative Reports, Device Cards, and Mesh Product Information

Documents like these may show the mesh type, the brand, the lot, and the implantation date. Records that may help confirm the product include:

• Medical records
• Operative reports
• Implant cards
• Device stickers
• Revision surgery records

The FDA explains that its unique device identification system is designed to identify devices from manufacturing through patient use.

Informed Consent Forms and Preoperative Notes

Informed consent forms and preoperative notes can show what risks were disclosed before your surgery.

Postoperative Records, Imaging, Cultures, and Pathology Reports

Postoperative records, imaging, cultures, and pathology reports can provide important documentation. They may show evidence of infection, fluid buildup, ruptures, tissue damage, or inflammation.

Revision Surgery Notes and Hospital Records

Revision surgery notes and hospital records may show why the removal or corrective breast mesh surgery was required.

Medical Bills, Lost Income, and Out-of-Pocket Costs

Records of medical bills, reduced income, and other costs related to the procedure may be used as documentation in a case, but they do not guarantee an outcome.

Qualifying for a breast mesh complication lawsuit means your case can be reviewed, but it doesn’t guarantee an outcome. The records and facts determine potential cases. Each case is also unique and attorneys will conduct their own review.

Lawsuits over breast mesh injuries may allege failures in warnings, design, testing, or marketing.

Public Rhode Island court records show a personal injury case titled Katherine Jamfar v. Davol, Inc. et al.

The case was filed in Providence/Bristol County Superior Court on April 28, 2026.

The listed defendants include:

• Becton, Dickinson and Company
• C.R. Bard, Inc.
• Davol, Inc.
• Galatea Surgical, Inc.
• Tepha, Inc.

A filing like this starts a case. No court has ruled that any of these defendants is at fault.

Failure to Warn About Breast Surgery Risks

Some claims may allege that patients or doctors lacked adequate information about the risks.

Defective Product Design or Inadequate Testing

Other lawsuits may claim the products were not adequately evaluated for use in breast tissue.

Off-Label Promotion or Misrepresentation of Device Safety

Claims in this area may involve promotion of mesh for breast procedures despite the lack of FDA clearance or approval for breast surgery. Misrepresentation of device safety may be alleged as well.

Failure to Update Warnings

Allegations may also involve delayed warning updates. The claim would be that complications became known and the warnings were not updated in time.

Negligent Surgical Use or Poor Informed Consent

Negligent surgical use or poorly informed consent may fall under malpractice issues. These claims would be separate from claims against the manufacturers of the breast mesh used.

A single case may involve several devices, more than one doctor, and more than one possible cause. Each part may need its own investigation.

Manufacturer, Surgeon, and Hospital Responsibility

Warnings from the manufacturer, hospital records, postoperative care, and judgment from surgeons may each have a role in breast mesh cases.

Rhode Island court records also show a case titled Laura Shrock-Popson v. Davol, Inc. et al.

It was filed in the same court on April 28, 2026. The defendant list matches the one above, including Becton, Dickinson and Company and Galatea Surgical, Inc.

Breast Implant vs. Breast Mesh Injury

An injury may involve the mesh, the implant, or the surgical technique. Infection can play a part as well. Several factors can be present at once.

Multiple Possible Causes of Injury

The defense may argue the injury was a known surgical risk. It may point to an unrelated health issue or surgeon error instead.

Medical care comes first if you have symptoms now, and your records come next. A free case review can then look at your options.

Free Breast Mesh Complications Case Review

If serious complications followed your breast mesh or internal bra surgery, you can request a free consultation here for a breast mesh lawsuit. The consultation is free, and it is not a guarantee of eligibility, recovery, or any outcome. This page provides legal information and does not constitute legal advice.