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An internal bra procedure is a surgical technique used during breast surgeries that places a piece of mesh to provide support for tissue or an implant. The term is frequently marketed during breast lifts, augmentations, and reconstruction surgeries, although many people may not realize it refers to the implantation of surgical mesh.
Recently, the procedure has raised questions about its safety since no surgical mesh products have been cleared for use in breast surgery by the U.S. Food and Drug Administration (FDA).
An internal bra procedure is a surgical technique that may be used during breast surgery. It involves placing a sheet of surgical mesh under the breast tissue or around an implant to provide support. The surgical mesh acts as a sling or scaffold, helping to hold the tissue or implant in position. The technique is designed to help reduce sagging and has been marketed as a way to increase the length of time that results last. The mesh is designed to be absorbed by the body over roughly one to two years. During that time, the patient’s own tissue grows into providing the necessary support.
As explained by the American Society of Plastic Surgeons, internal bras are rarely requested by a patient since they are a tool used during surgery and not a procedure in and of themselves. Surgeons may recommend or use the technique in a number of situations, including during cosmetic breast lifts (mastopexy), breast augmentation, or reconstruction after a mastectomy.
Two products are frequently associated with the internal bra technique: GalaFLEX and Phasix, both made by Becton, Dickinson and Company (BD). The mesh of both devices is made from a resorbable material called poly-4-hydroxybutyrate (P4HB). P4HB is a biologically produced, thermoplastic polyester first reported for implantable medical devices in 2003.
GalaFLEX and Phasix are marketed as temporary scaffolds. According to Becton, Dickinson's labeling, GalaFLEX is resorbed — gradually broken down and absorbed by the body — over approximately 18 to 24 months, and Phasix over approximately 12 to 18 months, with the patient's own tissue intended to grow in and take over support during that time. The FDA has not established the safety or effectiveness of this process in breast tissue.
While P4HB is used in GalaFLEX and Phasix surgical mesh products, others are made from acellular dermal matrix (ADM). These devices, including brands such as AlloDerm, FlexHD, and AlloMax, are made from processed human or animal tissue instead of synthetic fiber. Internal bra patients are encouraged to read more about breast mesh and the potential different types of devices that may be used in the technique.
In November 2023, the FDA issued a warning to providers about using surgical mesh during breast surgeries. The FDA made clear that there were no surgical mesh products that had been approved for use in breast surgeries. The letter specifically noted that the GalaFLEX and Phasix lines of products had been cleared for the repair and reinforcement of soft tissue, but that the safety and effectiveness of surgical mesh in breast surgery had not been determined by the agency.
GalaFLEX, in particular, received FDA clearance in 2014 through the 510(k) pathway. The 510(k) pathway is a faster route for a product to reach the market, compared to traditional methods. The pathway allows for products that are similar to other products already on the market to forego conducting new studies to prove it is safe and effective for a specific use. The product’s labeling indicates that its safety in breast surgery has not been studied.
To date, the safety and effectiveness of surgical mesh in breast surgeries have not been determined by the FDA. Despite this, the products are frequently used off-label in augmentations, lifts, and other breast surgeries.
In 2023, BD provided label updates on several of its surgical mesh products, including its Phasix and GalaFLEX product lines. The labeling updates were followed by an FDA letter to healthcare providers. The letter explained that the regulatory agency was aware of the increased use of surgical mesh in breast surgeries, but that the safety and effectiveness of the products had not been determined by the FDA.
As specified in the letter, the products had been cleared for the general purpose of repairing and reinforcing soft tissue where weakness exists. Breast tissue, however, is unique. An FDA advisory panel in 2019 had discussed the use of surgical mesh in breast surgeries. Since then, the FDA has not cleared or approved any surgical mesh for use in breast surgery.
Just two years after the advisory panel, the FDA provided a communication flagging higher complication rates for certain acellular dermal matrix products. These regulatory communications have raised safety questions about the use of these products in breast surgeries.
Despite the lack of FDA clearance discussed above, surgical mesh is frequently used off-label in breast surgeries, including augmentations and reconstructions, in a technique known as an internal bra. The lack of FDA approval for this particular use does not mean that every internal bra patient will have a problem or experience complications. It solely means that these products are regularly used in breast surgeries, despite not having undergone specific testing or studies for this purpose. Published research, however, has found complications may occur in some breast mesh procedures.
Many patients who have had breast surgery may be unaware of what type of surgical mesh they had implanted. Patients can identify the surgical mesh used in their surgery by requesting a copy of their operative report from the surgeon’s office or hospital. The operative report should list any products used during the surgery by name, including identifying the make, model, and lot number.
Patients considering an internal bra procedure during their breast surgery should review all FDA communications related to surgical mesh, as well as any product labeling. Patients can also discuss any concerns directly with their surgeon to determine the best course of action based on their individual circumstances.
Wisner Baum continues to investigate and accept breast mesh claims for individuals who have experienced complications after having surgical mesh implanted during a breast surgery or as part of an internal bra procedure. Patients are encouraged to contact the firm to secure a free, no-obligation case evaluation.
Eligibility to take legal action is not guaranteed and is determined on a case-by-case basis. Patients do not need to know which surgical mesh product was implanted to obtain a consultation. Attorneys with the firm can help to secure medical records and identify the brand name and manufacturer of the device. Contact Wisner Baum at (310) 207-3233 to get started today.
