What Is Breast Mesh or “Internal Bra” Mesh?

Breast mesh, often marketed as an “internal bra,” is a surgical scaffold made of poly-4-hydroxybutyrate (P4HB), a resorbable polymer. Surgeons place the mesh inside the breast during procedures such as mastopexy (breast lift), breast reduction, and breast reconstruction. The mesh is intended to support breast tissue, hold the lift in place, and slowly dissolve as the body grows replacement tissue around it.

The FDA Has Not Determined Breast Mesh Is Safe and Effective for Breast Surgery

The FDA issued a November 9, 2023 letter to health care providers about labeling updates for several Becton, Dickinson and Company mesh products, including Phasix and GalaFLEX products. The agency stated that these products are cleared for repair and reinforcement of soft tissue where weakness exists, but that the safety and effectiveness of surgical mesh in breast surgery, including augmentation or reconstruction, has not been determined by the FDA.

This lack of clearance isn’t limited to specific manufacturers. There are no surgical mesh products cleared or approved by the FDA for use in breast surgeries such as augmentation or reconstruction. The agency did not recommend removal in patients who have mesh but no symptoms. It did, however, encourage providers to report adverse events involving BD mesh products and surgical mesh products from other manufacturers.

That distinction matters. A product may be cleared for one type of soft-tissue reinforcement but still lack FDA clearance or approval for breast surgery.

What Complications Are Being Reported?

Breast mesh injury investigations are reviewing reports of serious complications after internal bra procedures, including:

• Infection or abscess
• Chronic pain or nerve injury
• Seroma (persistent fluid buildup)
• Capsular contracture, where scar tissue hardens around an implant
• Mesh migration, detachment, or failure
• Implant shifting, rupture, or reconstruction failure
• Skin thinning, wound breakdown, or mesh exposure
• Additional surgery to revise, remove, or replace mesh or implants

Some patients report one complication. Others report a chain of problems, such as pain, swelling, implant instability, imaging concerns, revision surgery, infection, and removal.

The most legally significant cases are often those involving objective medical harm: hospitalization, surgical removal, repeated revision procedures, documented infection, failed reconstruction, or permanent deformity.

Why Breast Mesh Failure Can Be So Difficult to Fix

Mesh removal is not always simple. Once implanted, mesh may scar into surrounding tissue, partially absorb, fold, detach, or become difficult to separate from the breast pocket. If infection develops, surgeons may need to remove both the mesh and the implant. In some cases, reconstruction may need to be delayed until the tissue heals.

For patients who received mesh after mastectomy, the consequences can be especially serious. A failed reconstruction can mean additional surgeries, more scarring, delayed recovery, and a prolonged reminder of an already traumatic medical experience.

Which Breast Mesh Products Are Being Reviewed?

Current breast mesh lawsuit investigations have focused on mesh products used in breast reconstruction, augmentation, breast lift, and revision procedures. Public reporting and legal advertising have identified products such as GalaFLEX, Phasix, DuraSorb, AlloDerm, FlexHD, AlloMax, and SurgiMend as products being reviewed in connection with internal bra complications. AboutLawsuits reports that lawyers are investigating claims involving infection, nerve damage, capsular contracture, implant failure, and revision surgery after breast mesh implantation.

The strongest confirmed regulatory fact is broader than any single product. The FDA has stated that no surgical mesh product has been cleared or approved for breast surgery.

What Did the FDA Say About ADM Products in Breast Reconstruction?

In 2021, the FDA also warned about differing complication rates among acellular dermal matrix (ADM) products, a type of surgical mesh used in implant-based breast reconstruction. The FDA said certain ADM products may have a higher chance of complications or problems when used in these procedures.

What the FDA communicated in 2021 is important because it shows that concerns about mesh use in breast reconstruction are not new. Regulators have been tracking complication rates, product differences, and the limits of existing evidence for years.

What Are the Allegations?

Breast mesh lawsuits and investigations may involve several potential claims, depending on the facts:

• Failure to Warn – Patients may allege that manufacturers failed to adequately warn doctors and patients about risks such as infection, chronic pain, capsular contracture, mesh failure, implant loss, or revision surgery.
• Off-Label Promotion – A key issue is whether manufacturers promoted products for breast procedures even though the FDA had not cleared or approved surgical mesh for breast surgery.
• Defective Design – Some claims may argue that certain mesh products were not designed to withstand the biological and mechanical environment of the breast, especially when used to support implants over time.
• Medical Negligence – Some cases may also involve questions about what the surgeon told the patient, whether informed consent was adequate, whether the product was appropriate for that patient, and whether complications were recognized and treated properly.

Not every complication means there is a lawsuit. The medical records, product identification, warnings, consent forms, operative notes, and follow-up care all matter.

What Should Patients Look for in Their Records?

Patients who suspect a breast mesh injury should try to identify:

• The exact mesh product used
• The manufacturer and product lot number, if available
• The date and type of surgery
• Whether the procedure was reconstruction, augmentation, lift, or revision
• Whether the mesh was described as an internal bra, scaffold, matrix, sling, or reinforcement
• Any post-operative infection, pain, seroma, hardening, asymmetry, or implant failure
• Any additional surgery, explant, revision, or mesh removal
• Imaging records, especially if scarring or mesh placement affected follow-up care

The operative report is often the most important document because it may identify the product used and describe how it was implanted.

Who May Have a Breast Mesh Claim?

A potential claim may exist for someone who had surgical mesh placed during breast reconstruction, augmentation, lift, or revision surgery and later suffered serious complications such as infection, chronic pain, capsular contracture, mesh failure, implant loss, or revision surgery.

The strongest cases usually involve a clear product identification and a documented injury that required medical treatment. A bad cosmetic result alone may not be enough. A case is stronger when the harm is tied to measurable medical complications, surgical findings, or the need for removal or revision.

What Should Patients Do Now?

Patients should not stop follow-up care or make medical decisions based on a lawsuit investigation. Anyone with pain, swelling, redness, drainage, breast hardening, implant shifting, fever, or wound problems should contact a qualified medical provider.

Patients should also request their complete surgical and post-operative records. Those records may help determine whether mesh was used, what product was implanted, what warnings were given, and whether later complications may be connected.

Why These Cases Matter

Breast reconstruction and cosmetic breast surgery are deeply personal decisions. Patients deserve accurate information about the devices placed in their bodies, especially when a product is used in a setting where FDA-cleared or FDA-approved safety and effectiveness have not been established.

For many women, the issue is not regret over surgery. It is whether they were exposed to avoidable risk without adequate warning.

How McEldrew Purtell Can Help

McEldrew Purtell is reviewing potential breast mesh injury claims involving serious infections, chronic pain, implant failure, reconstruction failure, and revision or removal surgeries after internal bra mesh procedures. If you or a loved one suffered complications after breast mesh was used in a reconstruction, augmentation, lift, or revision procedure, contact McEldrew Purtell for a free consultation.