The “Internal Bra” Mesh Used in Breast Lifts Was Never FDA-Cleared for the Breast

If you had a breast lift, breast augmentation, or breast reconstruction in recent years, your surgeon may have used a piece of surgical mesh to support the breast — a technique widely marketed as an “internal bra.” What many patients were never told is that, according to the FDA, no surgical mesh has ever been cleared or approved as safe and effective for use in the breast.

Now, women around the country are reporting painful complications after mesh-assisted breast surgery, and attorneys have begun investigating claims against the companies that make these products. This article explains what the “internal bra” is, what the FDA has actually said, and what to do if you think you may have been affected.

What Is an “Internal Bra”?

“Internal bra” is a marketing phrase, not a single medical device. It describes surgical techniques meant to give the breast long-lasting internal support — for example, to hold a lift in place longer or to support an implant. Some versions of the internal bra use only the patient’s own tissue and stitches. Others place a sheet of surgical mesh inside the breast, where it is meant to act like a hammock or sling supporting the lower part of the breast.

This article is about the mesh versions. The mesh products most often discussed include:

• GalaFLEX (and related products such as GalaFORM and GalaSHAPE), made by Becton Dickinson through its Galatea Surgical unit. These are made from a slowly-dissolving material called P4HB.
• Phasix mesh, associated with C.R. Bard / Becton Dickinson, originally cleared for hernia repair and general soft-tissue reinforcement.
• Tissue-matrix products made from human or animal tissue, such as AlloDerm, Strattice, FlexHD, and AlloMax, which are also used to reinforce breast reconstructions.

Here is the key point: these products were cleared by the FDA for general soft-tissue reinforcement — things like hernia repair — not for the breast. Using them in the breast is what doctors call an “off-label” use. Off-label use is legal and sometimes appropriate, but it also means the product was not tested and approved for that specific purpose.

What the FDA Actually Said

In November 2023, the FDA issued a Letter to Health Care Providers about Becton Dickinson’s mesh products. In it, the agency stated that the safety and effectiveness of these mesh products have not been determined for use in breast reconstruction or augmentation, and it reminded doctors that no surgical mesh is FDA-cleared or approved for breast surgery. The manufacturer updated its product labels around the same time to add that warning — a change the FDA said was meant to make sure providers understood the products had not been shown to be safe and effective for the breast.

That 2023 letter was not the first warning. Back in 2021, the FDA issued a safety communication about certain tissue-matrix products used in breast reconstruction, noting reports of higher infection and removal (explantation) rates compared to other similar products.

It is important to be precise about what the FDA did and did not do. The FDA has not banned these mesh products and has not ordered a recall. What it did was warn that the products have not been proven safe and effective for the breast, and require clearer labeling. Whether a particular surgeon should have used mesh in a particular patient — and whether the patient was properly warned — are exactly the kinds of questions the lawsuits raise.

The Complications Women Are Reporting

According to lawsuits and reports gathered by consumer-safety outlets, women who had mesh placed during breast surgery have described a range of problems, including:

• Infection and, in some cases, abscesses;
• Seroma — a buildup of fluid — and chronic inflammation;
• Capsular contracture, where hardened scar tissue forms and can distort or tighten the breast;
• Mesh that shifts, folds, or detaches from where it was placed;
• Chronic pain, poor wound healing, and skin problems over the mesh;
• Breast distortion or asymmetry, and implant position problems; and
• The need for revision surgery — or, in some cases, surgery to remove the mesh and/or implants entirely.

One clinical review cited in reporting on these products found that roughly one in three mesh recipients experienced some kind of complication, and a smaller share needed their implants removed. A former Becton Dickinson medical director has also publicly warned that GalaFLEX is being used in the breast without evidence that it is safe and effective there, and raised a concern that mesh could even interfere with detecting a return of breast cancer on imaging.

These are reported outcomes and allegations. A court has not ruled that any of these products is defective, and the fact that a complication happened after surgery does not by itself prove the mesh caused it — that is a medical question that depends on each person’s records.

Is There a Lawsuit?

Not a class action — not yet. As of July 2026, breast-mesh “internal bra” claims are in an early stage. Attorneys around the country are investigating cases, and some individual lawsuits have reportedly been filed against the mesh manufacturers. But there is no certified class action and no consolidated federal proceeding gathering all of these cases before one judge.

The lawsuits generally allege that the manufacturers promoted their mesh for breast procedures the products were never approved for, and that they failed to adequately warn patients and surgeons about the risks. The companies deny wrongdoing, and none of them has been found liable. Whether any individual has a claim depends on the specific facts — which product was used, what the patient was told, what the medical records show, and how the injury unfolded. Those are questions for a lawyer and your doctors, not something a website can answer for you.

Who May Want to Look Into Their Options

You may want to check your options if:

• You had a breast lift, augmentation, or reconstruction that used surgical mesh or an “internal bra” technique with mesh;
• The product used was something like GalaFLEX, GalaFORM, GalaSHAPE, or Phasix (your operative records may list it); and
• You later experienced a serious complication — such as an infection, chronic pain, mesh failure, or a revision or removal surgery — that you believe may be linked to the mesh.

If that describes you, the most important step is to make sure any medical issue is being handled by your doctor. After that, gathering your operative report, the product name or sticker, and your medical records can help a lawyer figure out whether you may have a case.

What to Do Now

Here are the practical steps, in order:

• Talk to your surgeon or doctor. Ask whether mesh was used in your surgery and which product it was. Follow their medical guidance.
• Get your records. Request your operative report and any records that name the product — you are entitled to your own medical records.
• Write down your timeline. Note the date of surgery, when problems started, and any follow-up procedures.
• Don’t wait too long to ask. Every state has a deadline for taking legal action, and in many states the clock can start when you knew or should have known about the injury.

Checking your options is free, and a real person — not a chatbot — reviews every submission and reaches out only if you may have a case.

Common Questions