Internal Bra (Breast Mesh)

An “internal bra” is a surgical technique that uses a type of mesh material, sometimes referred to as breast mesh, to provide additional support for breast reconstruction, augmentation or revision surgery. Surgeons typically use these meshes to reinforce weakened tissue, create a secure pocket for a breast implant or provide extra lift and shape in cosmetic procedures.

The primary function of an internal bra is to act as scaffolding, supporting the lower portion of the breast and implant to prevent the breasts from sagging. Surgeons may suture the mesh to the chest wall or existing breast tissue, bridging the gap between the muscle and chest wall to help hold the implant in place.

It’s important to know that the FDA has not approved surgical meshes for use as internal bras in breast surgeries. The internal bra is an off-label surgical technique, and the FDA warns that it has not determined the safety and effectiveness of surgical mesh in breast surgery.

Internal bra meshes typically fall into two types: biologic and synthetic. Meshes made from biological materials are sometimes called matrices, and those made with synthetic materials are called meshes.

Synthetic & Resorbable Meshes:

Synthetic meshes used in breast reconstruction can be absorbable or non-absorbable. Resorbable synthetic meshes are designed to gradually dissolve in the body over the course of months up to a year or more, depending on the brand. The mesh is then replaced by the patient’s own tissue.

These include products made from P4HB (poly-4-hydroxybutyrate) used under brand names like GalaFLEX and Phasix. P4HB is a biologically derived polymer made from a naturally occurring metabolite found in the body.

Non-absorbable synthetic meshes are made from polypropylene plastic, similar to some hernia mesh and transvaginal mesh brands.

Biologic/ADM Meshes or Matrices

Biologic mesh sheets are made from animal or human tissues. They provide a tissue scaffold that the patient’s own tissues can grow into. The body ultimately replaces these materials with native tissue.

Introduced into the market in 1994, these meshes may also be called an acellular dermal matrix (ADM), and they are used in breast reconstruction, abdominal wall repair and to treat burns.

Biologic/ADM meshes include brands such as AlloDerm, Strattice and FlexHD.

Materials Can Affect Patient Outcomes

There are advantages and disadvantages to using a synthetic mesh versus a biological mesh. For example, synthetic meshes typically cost less, but they are less elastic and may increase inflammation.

Biologic or ADM meshes are more expensive, but they have a lower risk of capsular contracture (scar tissue on the implant) and better initial breast contouring. However, they can still result in complications and infection.

Make sure to talk to your doctor about the risks and benefits of each material if you are considering breast reconstruction using the internal bra technique with biologic or synthetic mesh.

The FDA has released multiple safety communications about the use of mesh in breast surgeries. The agency hasn’t approved mesh for use in breast surgeries, including the internal bra technique.

These mesh products were allowed on the market through the 510(k) “clearance” process intended for general soft-tissue support — not specifically for breast procedures. This is important because 510(k) clearance only requires demonstration of “substantial equivalence” to an existing product, not proof of safety and effectiveness in breast-specific applications.

The FDA has highlighted that some acellular dermal matrices (ADMs) and synthetic meshes are used in breast reconstruction and augmentation despite not being specifically indicated for these purposes — an “off-label” use. In 2021, the agency issued a communication warning that some brands of ADM may have significantly higher risks of complications than others.

Breast Mesh Recalls & Label Updates

There hasn’t been a recall specifically for breast mesh. Instead, the FDA announced label updates for internal bra mesh made by Becton, Dickinson and Company (BD) mesh products in 2023.

BD updated its warnings and precautions on the labels of several of its mesh products that are popular for breast surgeries. The company reiterated that these products are cleared for the repair and reinforcement of soft tissue where weakness exists. The label also adds that BD’s mesh devices haven’t been studied for use in breast reconstructive surgeries.

The FDA reaffirmed that no mesh products, including those manufactured by BD, are approved for use in breast surgeries and the agency hasn’t determined mesh’s safety and effectiveness in breast surgery.

Like any implantable device, internal bra meshes carry potential risks. Seroma (fluid buildup) and infection were the most common complications in studies.

Patients should watch for red-flag symptoms such as increasing pain, redness, fever, swelling or discharge at the surgical site and contact a healthcare professional if these issues occur.

Diagnosis of complications often involves a physical exam, followed by imaging such as an ultrasound or MRI to visualize the mesh and surrounding tissues.

There are several breast mesh brands used for internal bra techniques. One of the most popular internal bra meshes is GalaFLEX, but surgeons use several other brands depending on the patient. Several companies that make or market hernia mesh and pelvic mesh also make breast mesh.

Knowing which brand and type of mesh was used is essential for tracking your long-term care and responding to any potential recalls or safety alerts. You can find the brand of the mesh your surgeon used on your medical records and surgical report.

Revision or removal of internal bra mesh may be necessary to treat some complications, such as infection, chronic pain, skin erosion — when the implant is visible through the skin — and other serious issues. Only a licensed surgeon can tell you whether you need to remove the implant.

Some women may have permanent damage after internal bra mesh removal, such as pain, scarring and loss of reconstruction results. Lawyers are currently pursuing internal bra breast mesh lawsuits on behalf of women who were injured by these implants and had to have revision or removal surgery.

Right now, the FDA doesn’t recommend revision or removal of ADM implants as a preventative measure in people who aren’t having issues with their mesh.