Phasix Breast Mesh Lawsuit

Eligibility for a Phasix lawsuit is decided case by case. But most potential claims require Phasix use in breast surgery plus a serious complication. Medical records must support the complication.

Phasix mesh is a surgical mesh product associated with BD and C.R. Bard. BD describes Phasix Mesh as a fully absorbable mesh for ventral hernia repair and soft tissue reconstruction.

BD says it is indicated to reinforce soft tissue where weakness exists in plastic and reconstructive surgery and other soft tissue repair. This page focuses only on alleged injuries tied to breast surgery use.

Phasix Mesh, Phasix ST Mesh, and BD / C.R. Bard

Phasix and Phasix ST are mesh products from BD and C.R. Bard. Product names in medical records can vary, so the exact device must be confirmed through your medical documents.

An FDA letter to health care providers lists BD mesh products that may come up in breast mesh reviews:

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

Reviews may also involve surgical mesh from other manufacturers. 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.

How Phasix Mesh Has Been Used in Breast Surgery

Some surgeons reportedly used Phasix as support for breast tissue or implants. The procedures were sometimes described as an internal bra. Others were described as a scaffold or as mesh reinforcement.

A 2025 review looked at synthetic mesh used for soft tissue support in breast surgery. The procedures included mastopexy and mammoplasty. It also covered augmentation and reconstruction.

The review noted that the FDA considers the use of ADM or synthetic mesh in breast surgery off-label.

Breast Reconstruction

Phasix may have been used after mastectomy or other reconstructive surgery. It may have been placed to support implants or tissue.

Breast Augmentation

The mesh may have been used to support cosmetic breast implants. It may also have been placed to reinforce the implant pocket.

Breast Revision or Reduction Surgery

Some patients may have received Phasix during corrective or revision procedures. Others may have received it during a lift or reduction. Implant-related procedures may also have involved the mesh.

Internal Bra Procedures

“Internal bra” is a marketing or surgical description. It is not proof that a specific product was used. Records are needed to confirm Phasix.

The FDA has not determined that surgical mesh is safe and effective for breast surgery. That includes breast augmentation and reconstruction. This is not the same as a recall or a ban.

The same FDA letter says the agency is aware of increased mesh use in breast procedures. It also states that no surgical mesh products are cleared or approved by the FDA for that use.

FDA 510(k) Clearance vs. Breast Surgery Use

A 510(k) clearance generally means a device was found substantially equivalent to another device. It does not mean the FDA approved Phasix as safe and effective for breast surgery. The FDA states that no mesh products are cleared or approved for use in breast surgery.

FDA Labeling Updates for BD Mesh Products

FDA labeling updates for BD mesh products matter because the updates address warnings about mesh use in breast procedures. MedTech Dive reported that BD updated labels for multiple Phasix and GalaFLEX products.

The GalaFLEX LITE warning section states the device “has not been studied for use in breast reconstructive surgeries,” the outlet reported. The article also said no mesh products are cleared or approved by the FDA for breast surgery.

Why Off-Label Breast Use Matters

Off-label use can be legal for doctors, but lawsuits may focus on the manufacturers instead. They may ask whether the companies tested the mesh enough for breast use. They may also ask how it was marketed and what warnings were given.

The complications below are reported injuries. They may support a case depending on timing and severity. Records and medical causation also matter.

One reported example in these cases is a hematoma. Cleveland Clinic describes a hematoma as a closed wound where blood collects inside the body because it cannot flow or drain out. Pooled blood can push nearby tissue outward and cause pain and swelling.

A 2025 review of mesh use in breast surgery reported a pooled hematoma rate of 1.34%. The authors noted the current data are limited. They also said the data do not support claims of better cosmetic outcomes with mesh.

Infection or Abscess

Late or serious infection can be an important factor. An abscess can be too. Records of antibiotics or drainage may matter. Hospitalization or removal of the mesh or implant may matter as well.

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

The 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%.

Seroma or Fluid Buildup

A seroma is a pocket of fluid that builds up under the skin, Cleveland Clinic explains. It most often happens after surgery. Most seromas are not dangerous. But some can lead to problems during healing.

Chronic or recurring fluid buildup may matter in a claim. Repeated aspirations and swelling are also relevant facts. Pain and follow-up surgery can count as well. The 2025 review reported a pooled seroma rate of 5.04% in the studies it examined.

Capsular Contracture

The American Society of Plastic Surgeons explains that capsular contracture happens when scar tissue around an implant becomes unusually hard and tightens. This can affect how the breast looks.

It can cause pain and tenderness in more severe cases. Some cases may need more aggressive surgical treatment.

The FDA describes it as scar tissue that forms around a breast implant and squeezes the implant. It says the scar tissue can cause hardening and tightness around one or both implants.

It may be painful and severe cases may require another operation. Distortion or deformity around the implant may lead to revision surgery.

Chronic Pain or Nerve Damage

Reported nerve symptoms after mesh placement include:

• Burning or stabbing pain
• Numbness or sensitivity
• Tingling or prickling
• Hypersensitivity
• Long-term chest or breast pain

WebMD explains that nerve damage can seriously affect quality of life. It also says nerve damage may not always be fully curable.

A systematic review found nerve injury after breast augmentation was reported in the studies it reviewed. But the data were not enough to determine nerve injury rates for mastopexy. The risk may depend on the procedure and the facts of the case.

Mesh Migration or Displacement

Shifting or movement of the mesh, loss of support, displaced mesh, and asymmetry can be signs of complications. This can be a sign.

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

Skin Necrosis or Wound Breakdown

Serious reported complications include tissue death and open wounds. They also include poor healing and debridement. Implant exposure and skin loss are reported as well.

Necrosis can happen when breast skin does not heal properly and does not get enough blood flow, Breastcancer.org explains. Areas of the skin can wither, scab, and die.

Johns Hopkins Medicine describes necrotizing soft tissue infection, a condition distinct from postoperative skin necrosis, as a life-threatening condition caused by bacteria invading the skin or the tissue under it. The condition needs treatment right away.

Untreated cases can destroy tissue and can lead to amputation or kidney failure, making the risk of death high.

Implant Rupture or Implant Loss

Implant rupture means the implant’s outer shell develops a tear or hole, Breastcancer.org explains. Signs of a rupture may include:

• Changes in breast shape or size
• Pain
• Firmness
• Swelling
• Capsular contracture

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

The FDA describes rupture as a tear or hole in the outer shell of a breast implant. It says silicone implants can rupture at any time after surgery. The chance rises the longer the implant stays in place.

Rupture and removal may be relevant facts when tied to mesh-related complications. Losing a reconstruction may be relevant too.

Revision Surgery, Explant Surgery, or Reconstructive Failure

More surgery is a key case fact in these claims. Mesh removal and implant removal both count. Failed reconstruction and repeated corrective procedures count as well.

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

A 2021 study described implant loss as the most severe complication of implant-based breast reconstruction. It reported an 11.8% incidence. The data came from two medical centers, so the results may not apply to all reconstruction patients.

Breast implant complications may require more operations, with or without removal of the device, the FDA states. It notes there is no guarantee of a satisfactory cosmetic outcome after a reoperation.

Some patients were never told the brand name of their mesh. That uncertainty shouldn’t stop you from requesting records or speaking with an attorney.

The FDA explains that a device identifier can identify the label and the specific version or model of a device. But its AccessGUDID database does not show who used the device. It doesn’t include personal patient information either.

Check Your Operative Report

The operative report may list the implanted mesh name and manufacturer. It may also list a catalog number or other device details.

Ask Your Surgeon or Surgical Center

You can ask directly for implant records and device stickers. Supply logs and post-op notes can help too.

Look for Terms Like Internal Bra, Scaffold, or Surgical Mesh

These terms in your records may point to mesh use. But they do not prove Phasix was used. Only records that name the product can confirm it.

Patients may claim inadequate warnings or defective design. Improper promotion and a lack of informed consent may also be alleged. These theories are allegations, not court findings.

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

Failure to Warn Claims

Plaintiffs may allege that BD and C.R. Bard failed to adequately warn doctors or patients. The claims involve the risks of Phasix in breast tissue. Court records show a second case, Laura Shrock-Popson v. Davol, Inc. et al. It was filed in the same court on April 28, 2026. The defendant list includes the same companies.

Defective Design Claims

Some claims may allege that the mesh design or material created unreasonable risks in breast procedures.

Off-Label Marketing Allegations

Lawsuits may investigate whether the companies promoted or encouraged breast use of the mesh. They may ask if that promotion happened without adequate clinical support.

Inadequate Patient Consent Allegations

Some patients may claim they were not clearly told the mesh was not FDA-cleared or approved for breast surgery specifically.

Damages depend on the facts of each case. A Phasix breast mesh injury lawsuit may seek several types of losses. No outcome or amount is ever promised.

Medical Bills and Future Treatment

These damages may cover past and future care, such as:

• Revision surgery
• Explant surgery
• Hospitalization
• Antibiotics
• Wound care
• Imaging
• Specialist visits
• Future procedures

Pain and Suffering

This part of a claim may cover physical pain and chronic symptoms. Sleep disruption and daily limits may be included.

Lost Income

Missed work, reduced hours, and recovery time may count. If reduced earning capacity is medically supported, it may be included.

Scarring, Disfigurement, or Loss of Reconstruction

Breast deformity, visible scarring, and asymmetry may be covered here. A claim may also address implant loss or a failed reconstruction.

Emotional Distress and Loss of Quality of Life

Anxiety and embarrassment may be included. Harm to body image and intimacy can be part of a claim, as well as losing normal activities.

A recall is not the same as a labeling update. It is also not the same as an adverse event report. The FDA label changes for BD mesh products were labeling updates, not a recall. This page makes no claim that a verified Phasix mesh recall exists.

The time you have to file a Phasix mesh lawsuit depends on your state. Each state sets its own statute of limitations. Discovery rules may also affect the timing in some cases. You should not assume you are too late without a case review.

Start by preserving your records and tracking your symptoms. Avoid guessing about legal deadlines. Then get a confidential legal review.

Gather Medical Records

Useful records include:

• Operative reports
• Implant cards
• Pathology reports
• Imaging
• Revision notes
• Hospital records
• Billing records

Unique device identifiers are used to identify devices from manufacturing through patient use, the FDA says. Device information may identify the labeler and the model of a device. It may also show the lot or batch number, serial number, expiration date, or manufacturing date when that information is included.

Document Symptoms and Surgeries

Keep a simple timeline of what happened and when. Write down your surgery date and when symptoms started. Add each diagnosis and treatment. Note any revision procedures and the limits you still face.

Speak With a Phasix Breast Mesh Lawyer

An attorney can help review your records and confirm the product used. A lawyer can also review the deadlines that apply. The attorney can then explain whether your facts may support a claim.

If you had Phasix mesh placed during breast surgery and serious complications came later, you can request a free case review. Submitting a request does not create an attorney-client relationship, and matters may be referred to other firms. The review is confidential. It is not a promise of any outcome.

Get a Free Consultation for a Breast Mesh Lawsuit. A case review can show whether your facts may support a claim.