AlloDerm Breast Mesh Lawsuit

AlloDerm is a surgical mesh made from donated human tissue in the form of an acellular dermal matrix (ADM), known as AlloDerm RTM. LifeCell’s AlloDerm RTM is a prescription-only product used to reinforce soft tissue. Alloderm may be used in several breast surgery procedures, including:

• Reconstruction of the breasts
• Breast Implants
• Lifting of the Breasts
• Breast Surgery Revision

AlloDerm is used as an internal bra in cases of inadequate breast tissue as a support. It may also support breast tissue during reconstruction.

AlloDerm, LifeCell, Allergan, and AbbVie

The product AlloDerm was originally manufactured by LifeCell Corporation. LifeCell was acquired by Allergan in 2017. In 2020, Allergan became a wholly owned subsidiary of the biopharmaceutical company AbbVie.

Many surgeons refer to the breast mesh that they use in breast surgery as an “internal bra.” The internal bra technique is used to place mesh inside the breast to provide structural support for breast tissue or implants. Some patients may not realize that mesh was used during their surgery procedure.

Biologic Mesh vs. Synthetic Mesh

Many brands and types of mesh are used in surgery, including both biologic and synthetic varieties.

AlloDerm is a biologic ADM made from human tissue. GalaFLEX, Phasix, and DuraSorb are all made from synthetic materials. Thus, they are quite different and should not be confused.

Some uses of AlloDerm in breast surgery may be off-label.

Alloderm is being investigated for several reasons, including:

1. Whether AlloDerm’s manufacturer provided enough warning to patients and doctors of the risks of use in breast surgery
2. Whether the manufacturer promoted AlloDerm for uses not cleared or approved by the FDA.
3. Whether enough studies were conducted to support the use of AlloDerm in breast surgery.

Off-Label Use, Off-Label Promotion, and FDA Clearance

Surgical mesh products have not been cleared or approved by the FDA for use in breast surgery procedures.

The FDA is aware that surgical mesh products are increasingly being used in breast surgery. However, the FDA has not determined if surgical mesh is safe and effective for such use.

FDA Warnings May Affect Alloderm Breast Mesh Claims

FDA communications about label changes in surgical mesh products may be relevant to the claims in an Alloderm breast mesh lawsuit. Such changes could support claims that the manufacturer knew of the product’s risks of use but did not communicate them to users.

Reported complications of breast mesh using AlloDerm include the following:

Hematoma, Infection, Abscess, or Seroma

A review of postoperative complications in breast mesh surgeries eported the following complication rates:

Hematomas occurred in 1.34% of surgeries. A hematoma is pooled blood inside the body from a closed wound that cannot drain. The hematoma swells and becomes painful as blood pushes against surrounding tissue.

Infections and abscesses occurred in 2.36% of surgeries. A life-threatening infection or abscess can develop in the soft breast tissue from untreated bacteria under the skin. This type of infection must be treated immediately.

Seromas occurred in 5.04% of surgeries. A seroma is a pocket of fluid that forms under the skin after surgery, which can make healing difficult.

These complications may require:

• Antibiotics for infection
• Drainage for fluid buildup
• Implant removal or revision surgery in serious cases

Capsular Contracture, Chronic Pain, or Nerve Symptoms

There is also the risk of:

Capsular contracture, which is when a breast implant is surrounded by a ‘capsule’ of scar tissue. It can cause the implant to become hard and painful. In severe cases of capsular contracture, further surgery may be required to remove the scar tissue.

Nerve damage during breast surgery can result in pain, numbness, chronic pain, and a burning sensation. Although some nerve damage can heal, there is also a chance it may be permanent.

Mesh Failure, Migration, or Loss of Support

The breast may shift or change in form after reconstruction. The implanted mesh may stretch, become distorted, or develop folds in it. In some cases, it may become loose, and more surgery may be required to correct it.

Skin Necrosis, Wound Breakdown, or Reconstruction Failure

Necrosis of the breast tissue skin occurs when the tissue does not heal properly due to poor blood supply to the area. This can cause severe pain and discomfort.

Implant Loss, Explant Surgery, or Revision Surgery

Complications such as implant rupture due to a tear or hole can result in serious injury or loss of the implant. A ruptured breast implant may need to be removed in an explant surgery.

In the event of a rupture, a corrective revision surgery may be necessary. A paper published by Yale Medicine describes such surgery as a redo of the previous surgery. Many revision surgeries are more complex than the original operation.

The term “mesh” is often used by plastic surgeons to describe the type of product that will be used during your breast reconstruction surgery.

Request Your Operative Report and Implant Records

The operative report and implant records may help identify the breast mesh product used in your procedure.

Implant Stickers, Lot Numbers, or Device Records

Implant packaging, including stickers with product information, contains a device identifier.

The identifier can identify the specific model of a product or device from manufacturing through to patient surgery.

What to Do If You Do Not Know the Mesh Brand

A lawyer may help you get records and identify the product used in your case review.

An AlloDerm lawsuit is developed by combining evidence from several sources. Sources can include surgical records and follow-up notes. Personal, family, and financial records or notes can also be good sources of evidence.

Surgical and Follow-Up Treatment Records

Collect any operative reports and records detailing your treatment. This includes details of:

• The first time that you experienced complications from your breast surgery
• A full and detailed description of the pain that you have experienced since your surgery
• How it has affected you in respect to your work and/or home.

Revision or Removal Records

Collect any records explaining:

• The problems caused by Alloderm mesh in the original surgery
• Why mesh removal or revision surgery is necessary

Photos, Symptoms, and Personal Documentation

Photos, a simple symptom log, and personal notes can help establish:

• Complications that were experienced
• Pain levels and flare-ups
• Effects on work, sleep, or daily life

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

To help establish the financial loss you experienced, collect:

• Medical bills
• Medication receipts
• Travel expenses
• Other financial evidence

Time sheets and personal work logs documenting work missed due to your injury can be used to establish lost wages.

The claims in an AlloDerm Breast Mesh lawsuit can depend on a variety of factors, including:

• State laws
• The History of the AlloDerm Product
• Medical facts of the case
• Timing

Failure to Warn

Manufacturers of AlloDerm may have failed to warn of possible complications from its use in breast surgery.

Defective Design or Negligence

The makers of AlloDerm allegedly placed the product on the market knowing of a defect in the design. Claims also assert that the manufacturer of AlloDerm failed to exercise due care in testing and monitoring the product.

Misrepresentation or Inadequate Marketing Disclosures

AlloDerm was allegedly marketed for breast surgery uses not cleared or approved by the FDA. Additional claims are that the company overstated the safety of its product for these purposes.

Failure to Properly Study Breast Surgery Risks

Claims allege AlloDerm breast mesh was used in breast surgery without adequate safety studies or specific breast mesh use risk warnings.

Lawsuits involving AlloDerm have been filed for many years before the breast mesh lawsuits now being filed. However, prior litigation does not ensure that a breast mesh claim will succeed.

Earlier AlloDerm Hernia Mesh Lawsuits

In some hernia mesh cases, plaintiffs have alleged early product failure requiring additional surgery. In many of these cases, the Hernia Mesh products had stretched, failed, or did not provide adequate support for the hernia repair.

Allegations Against LifeCell

Plaintiffs have alleged that LifeCell:

• Designed a defective product
• Failed to warn of the known and foreseeable risks of using AlloDerm, and
• Conducted inadequate testing prior to marketing to ensure that the product would not cause injury to users.

Relationship to Current Claims and Litigation

While prior lawsuits and claims may affect the warning and risk claims in breast mesh cases, each case will require a breast product, an injury, and evidence to support the claims.

Alloderm Breast Mesh and breast mesh products made by other companies are used in breast surgeries. Most products are used to provide soft tissue support in such surgeries.

There are currently lawsuits making their way through the court system for other products. Two cases, Katherine Jamfar v. Davol, Inc. et al. and Laura Shrock-Popson v. Davol, Inc. et al., were filed in April 2026 in the state of Rhode Island. Both cases list a variety of defendants including Becton, Dickinson and Company, C.R. Bard, Davol, Galatea Surgical, and Tepha.

Other Biologic ADM and Synthetic Internal Bra Mesh Products

Biologic ADM Products include:

• Allergan (now a subsidiary of AbbVie) makes a pig-tissue-based ADM called Strattice.
• Two human-derived ADMs are on the market at the time of writing, AlloMax and FlexHD, made by Bard/Davol and MTF Biologics, respectively.

Synthetic Internal Bra Mesh Products

Synthetic Internal Bra Mesh Products include:

Two synthetic P4HB mesh ADMs are currently available, GalaFLEX and Phasix.

A single synthetic internal bra mesh that dissolves over time, DuraSorb, is available on the market. There is a new version of GalaFLEX, GalaFLEX LITE, but it has not been studied for use in breast surgeries, according to a recent warning added to the product’s label by BD, as reported by MedTech Dive.

No lawyer can guarantee the value of your case or the outcome of your case for a settlement.

Are There AlloDerm Breast Mesh Settlements?

To date, there are no verified public large-scale settlements involving AlloDerm breast mesh. These cases are still in the early stages of litigation.

Factors That May Affect Case Value

Several factors may affect a case’s value:

• How severe the complications are
• Revision surgery or implant loss
• Whether the injury is permanent
• Medical costs and lost wages
• Documented pain and suffering
• Strength of your medical and product records

Why Revision Surgery and Implant Loss Matter

Details of any revision surgery or implant loss can serve as evidence of severe physical injury. It can also be used to show the physical and economic harm that you endured.

How Comparable Mesh Litigation May Influence Future Settlements

Hernia Mesh Cases are listed as background or comparative mesh litigation. These cases are completely different from Breast Mesh Cases. Hernia Mesh lawsuits involve mesh used for different purposes, different products, and different injury claims than Breast Mesh lawsuits. As such, future settlements in breast mesh lawsuits may not be affected by other mesh lawsuits.

Get Medical Care First

Seek medical treatment for your injuries first. Then seek legal representation for the problems that the mesh implant may have caused you.

Preserve Your Records

Keep all your operative records, the packaging stickers for your implants, before-and-after photos, and all corresponding medical bills. These, in addition to your corresponding notes regarding your symptoms, may serve as evidence of your injuries and suffering.

Do Not Wait to Check Your Filing Deadline

A missed filing deadline can bar an otherwise valid claim. So, it is best to have someone review your state’s required filing deadline as soon as possible.

Speak With an AlloDerm Breast Mesh Lawyer

An experienced AlloDerm Breast Mesh Lawyer can assist with reviewing your potential claim, including identifying the AlloDerm Mesh product used, the applicable filing deadline, and available legal options.

Frequently Asked Questions About AlloDerm Breast Mesh Lawsuits

Is AlloDerm the Same as Breast Mesh?

AlloDerm is a biologic surgical mesh product made from donated human tissue. It is only one of the many breast mesh products on the market today.

Is AlloDerm Used in Internal Bra Surgery?

Yes. An internal bra made from AlloDerm is sometimes placed in breast reconstruction, augmentation, lift, and revision surgery for support.

Can I File a Lawsuit If I Do Not Know the Mesh Brand?

Possibly. Medical records can often help identify the brand before a final decision is made.

Do I Need Revision Surgery to Qualify?

Revision surgery is not necessarily required for a breast implant complication lawsuit. However, serious and documented complications, such as those requiring revision, implant failure, or implant rupture, may strengthen a case.

What If My Surgeon Said AlloDerm Was Safe?

AlloDerm product-liability claims are generally directed at the product manufacturer rather than the surgeon who performed the surgery. They are against the product manufacturer regarding design, marketing, and warnings.

How Long Do I Have to File a Claim?

The statute of limitations varies by state. It often depends on the date of injury or the date of discovery of a possible link between the product and the injury. Speak with a lawyer to review your case and determine the applicable filing deadline in your state.

What Is the Cost to Speak with a Lawyer?

Often, attorneys will offer a free initial consultation. Product liability case lawyers typically work on a contingency basis. They receive no attorney’s fee for their services unless they win the case for you through a settlement or verdict.

Contingency Fee Disclaimer: Clients may be responsible for court costs. In some cases, they may also be responsible for opposing parties’ fees if a recovery is not obtained.

Women who have experienced Alloderm Breast Mesh Surgery complications can receive a free legal review. There is no obligation, and we treat consultation communications as confidential.

Contact us for your free consultation.