FDA Warns Some Surgical Meshes Have Higher Complication Rates: What Patients Need to Know

For patients navigating the difficult journey of a mastectomy, implant-based breast reconstruction can be a critical step toward healing and recovery. Surgeons often use a type of surgical mesh called an acellular dermal matrix (ADM) to help support the implant and create a more natural look. However, a safety warning from the U.S. Food and Drug Administration (FDA) has raised serious concerns about the complication rates associated with specific brands of these mesh products.

If you have undergone or are considering implant-based breast reconstruction, this information is vital for your health and your legal rights. The experienced team at Walch Law is here to help you understand what this FDA warning means. Our consultations are always free and confidential, and you pay nothing unless we secure a financial recovery for you.

What the FDA Said About ADM Surgical Mesh

On March 31, 2021, the FDA issued a safety communication to inform patients and doctors about the risks associated with certain ADM products.¹ ADM is a type of surgical mesh made from human or animal skin where the cells have been removed, leaving a structural framework.

The FDA noted that while ADM products have been cleared for uses like hernia repair, their use in breast reconstruction is considered “off-label.” This means the FDA has not specifically cleared or approved these devices for this purpose, and their safety and effectiveness in breast reconstruction have not been formally established by the agency.¹

Key Findings from the FDA’s Analysis

The FDA’s warning was based on its analysis of a study that followed patients for two years after they had implant-based breast reconstruction. The findings were significant. Patients who received certain brands of ADM—specifically FlexHD and AlloMax—had much higher rates of serious complications compared to patients who received other brands (SurgiMend or AlloDerm) or no ADM at all.

The specific complications observed at a higher rate included:

Explantation: The need to surgically remove the breast implant.
Reoperation: The need for additional, unplanned surgeries to correct problems.
Infection: Developing a serious infection at the surgical site.

Despite these risks, the FDA stated that it does not recommend the preventive removal of already implanted FlexHD or AlloMax mesh for patients who are not experiencing problems.¹

What Patients Should Discuss with Their Surgeons

This FDA warning empowers patients to have more informed conversations with their healthcare providers. Whether you are planning for reconstruction or have already had the procedure, it is crucial to discuss these points with your surgeon.

What are the risks and benefits of using ADM in my reconstruction versus not using it?
Which brand of ADM do you plan to use, or which brand was used in my surgery?
What are the known complication rates for that specific brand?
What are the alternatives to using ADM?
How will you monitor me for complications like infection or implant failure?
What is the plan if a complication does occur?

If you experience any problems with your breast implants or surgical mesh, the FDA encourages you to report them through its MedWatch adverse event reporting program.²

The Legal Context: Your Rights as a Patient

When a medical device is linked to higher complication rates, it can raise serious legal questions about product liability and medical negligence.

Informed Consent: Your doctor has a duty to inform you of the known risks, benefits, and alternatives to a procedure, including the off-label use of a medical device. If the risks of a specific mesh brand were known but not disclosed to you, your informed consent may have been compromised.
Product Liability: Manufacturers of medical devices have a responsibility to ensure their products are safe. If a device like FlexHD or AlloMax has a design or manufacturing defect that makes it more prone to causing complications, the manufacturer could be held liable.
Documenting Your Harm: If you suffer complications, it is essential to document everything. This includes the financial costs of additional surgeries and medical care, lost wages from missing work, and the significant physical and emotional distress you have endured.
Statutes of Limitation: Every state has strict time limits for filing a lawsuit. It is critical to speak with an attorney as soon as you suspect a problem to protect your legal rights.

Evidence Checklist: What to Gather If You Have Complications

If you have experienced complications after breast reconstruction with surgical mesh, gathering the right evidence is the first step in building a potential legal claim.

The operative report from your reconstruction surgery, which should identify the brand and lot number of the mesh used.
The product labels or stickers for your breast implant and the ADM product.
Clear photos of any signs of infection, implant displacement, or scarring.
All clinic notes from your plastic surgeon and other treating physicians.
The results of any fluid cultures or pathology reports from subsequent surgeries.
Records of any reoperations, including explant surgery.
All medical bills and a record of your out-of-pocket expenses.
A copy of the MedWatch report if you or your doctor filed one.²
A personal journal detailing your symptoms, pain levels, and the emotional impact of the complications.

What to Do Next

If you are concerned about your breast reconstruction, your first step should always be to speak with your treating surgeon. Do not hesitate to seek a second opinion from another qualified plastic surgeon if you feel your concerns are not being addressed.

You have the right to request a complete copy of your medical records. Once you have them, the experienced legal team at Walch Law can review them to determine if you may have a claim. We work with medical experts to analyze complex cases and will handle every aspect of the legal process, including managing and reducing medical liens, so you can focus on your health.

We Are Here to Help

Learning that a device used in your recovery may have put you at greater risk is distressing. You do not have to face this alone. Contact Walch Law today for a free, confidential consultation to discuss your situation and learn how we can help you seek the justice you deserve.

¹ FDA In Brief: FDA Warns About Differing Complication Rates for Acellular Dermal Matrix, a Type of Surgical Mesh, Used in Implant-Based Breast Reconstruction
² MedWatch: The FDA Safety Information and Adverse Event Reporting Program