Breast Mesh Lawsuits and FDA Approval Process : Understanding the Concerns

Most people assume that every medical device used during surgery has been specifically approved for that procedure. That isn’t always the case. In recent years, breast mesh has become the subject of growing legal scrutiny after some patients reported serious complications following breast augmentation, breast lift, and reconstructive procedures. At the center of many of these lawsuits is an important question: Has the FDA approved surgical mesh for use in breast surgery?

The answer surprises many patients. According to the U.S. Food and Drug Administration (FDA), no surgical mesh has been cleared or approved for use with breast implants or breast reconstruction. That does not automatically mean a product is unsafe, but it does raise important questions about how these devices are used and what patients should know before surgery.

What Is Breast Mesh?

Breast mesh is a material that some surgeons use to provide extra support during breast surgery. You may also hear it called an “internal bra.” Depending on the product, the mesh may dissolve over time or act as a temporary support while new tissue develops. Surgeons may recommend it for patients who have weakened tissue, are undergoing revision surgery, or want additional support for breast implants. While breast mesh has been promoted as an option in certain procedures, many patients are unaware that its use in breast surgery differs from how these products were originally reviewed by the FDA.

Why Is FDA Approval Important?

The FDA evaluates medical devices for specific uses before they are marketed for those purposes. Some surgical mesh products have been cleared for procedures involving weakened abdominal tissue or hernia repair. However, the FDA has stated that it has not cleared or approved surgical mesh for breast implants or breast reconstruction.

Important FDA Labeling Update: Becton, Dickinson and Company (BD) Mesh Products

On November 9, 2023, the U.S. Food and Drug Administration (FDA) issued a labeling update pertaining to specific surgical mesh products manufactured by Becton, Dickinson and Company (BD). While these products are indicated for soft tissue repair and reinforcement, they are not approved for use in breast surgery.

The FDA’s updated labeling explicitly states that the safety and effectiveness of surgical mesh in breast procedures—including augmentation and reconstruction—have not been established by the agency.

Affected BD Mesh Products

The following products are subject to this labeling update:

• Phasix™ Mesh
• Phasix™ ST Mesh
• Phasix™ Plug and Patch
• Phasix™ ST Mesh with Open Positioning System (OPS)
• Phasix™ ST Mesh with Echo 2™ Positioning System
• GalaFLEX Lite™ Scaffold
• GalaFLEX™ Scaffold
• GalaFLEX 3D™ Scaffold
• GalaFLEX 3DR™ Scaffold

That distinction matters because approval for one procedure does not automatically apply to another. A device may be legally available while still lacking FDA clearance for a different surgical use.

Does That Mean Breast Mesh Is Unsafe?

Not necessarily. A lack of FDA approval does not automatically mean a medical device is defective. It simply means the FDA has not reviewed the product for that particular use.

Doctors are sometimes allowed to use medical devices “off-label,” meaning they use an approved device in a way that differs from its original purpose. Off-label use is legal in many situations, but patients should understand why a device is being recommended and what risks may be involved. Being informed before surgery allows patients to ask questions, weigh their options, and make decisions with confidence.

Why Have Breast Mesh Lawsuits Been Filed?

Breast mesh lawsuits generally involve patients who claim they experienced serious complications after mesh was implanted during surgery.

Some of the reported complications include:

• Chronic pain
• Infection
• Inflammation
• Fluid buildup around the implant
• Mesh erosion or migration
• Additional surgeries to remove or replace the mesh

Every case is different. Some lawsuits also allege that patients were not fully informed that surgical mesh would be used or that the product had not been cleared or approved by the FDA for breast augmentation or reconstruction.

Questions to Ask Before Breast Surgery

Every patient has the right to understand the procedure they are considering. Asking questions before surgery can help you make a more informed decision.

Some questions to discuss with your surgeon include:

• Will surgical mesh be used during my procedure?
• Why is it being recommended?
• What are the possible risks and complications?
• Are there alternatives to using mesh?
• What symptoms should I watch for after surgery?
• Could additional surgery be necessary if complications occur?

Open communication can help patients better understand both the benefits and potential risks of their treatment plan.

When Should You Consider Speaking with an Attorney?

Not every complication leads to a lawsuit. However, if you experienced unexpected injuries after breast mesh was used during surgery, it may be worth learning more about your legal rights. You may want to speak with an attorney if you required additional surgeries, developed a serious infection, experienced ongoing pain, or later discovered information about the medical device that was not discussed before your procedure. An attorney can review your medical records, explain how the law applies to your situation, and help determine whether compensation may be available.

Alonso Krangle Fight for Victims

Medical devices are intended to improve patient outcomes, but when questions arise about their safety or use, patients deserve clear answers. If you experienced complications after breast mesh was used during surgery, understanding your legal rights is an important first step. The law firm of Alonso Krangle represents clients throughout Long Island, Nassau County, Suffolk County, Queens, and New York in defective medical device cases. The firm is committed to helping injured patients understand their options and pursue accountability when appropriate. If you believe breast mesh complications have affected your health, contact Alonso Krangle LLP for a free consultation and confidential case evaluation. 800-403-6191 or contact us online to discuss your potential claim.