Thousands of women across the country are coming forward with a story they share in common: they went in for a breast surgery, came out with a piece of surgical mesh sewn into their chest that they were never told about, and have been living with the consequences ever since. Now, those women are suing.
C.R. Bard breast mesh lawsuits, sometimes called internal bra lawsuits, are one of the fastest-growing areas of product liability litigation in 2026. The lawsuits target Becton, Dickinson and Company and its C.R. Bard and Davol subsidiaries, whose GalaFLEX and Phasix mesh products were sold to plastic surgeons and reconstructive surgeons for use in breast augmentation, breast lift, and post-mastectomy reconstruction procedures, even though the U.S. Food and Drug Administration has never approved any surgical mesh product for use in the breast.
If you or someone you love had breast surgery involving GalaFLEX, Phasix, or another mesh and later experienced infection, chronic pain, reconstruction failure, or a revision surgery, you may have a legal claim. Here is what you need to know.
What Is an “Internal Bra”?
The “internal bra” is a marketing term for a surgical technique in which a sheet of mesh is implanted inside the breast to provide structural support. The idea is to reinforce the tissue around a breast implant, hold up a breast lift, or rebuild the breast pocket after a mastectomy.
The BD and Bard products used as internal bras are synthetic. GalaFLEX and Phasix are both knitted from a polymer called poly-4-hydroxybutyrate, usually shortened to P4HB. The mesh is sold as bioresorbable, meaning it is supposed to break down and disappear from the body within roughly 18 to 24 months. Women who have sued say the mesh was still there long after that, and that nobody warned them it might be.
Many patients were never told that mesh would be used in their surgery, and many more were never told that the mesh had not been tested or approved by the FDA for use in the breast.
The FDA Never Approved These Products for Breast Surgery
This is the heart of the litigation. The FDA cleared GalaFLEX and Phasix for general soft-tissue reinforcement or for hernia repair. Neither has been cleared or approved for breast surgery. GalaFLEX reached the market in 2014 through the FDA’s 510(k) pathway, which asks only whether a new device resembles one already for sale, not whether it is safe and effective for any particular procedure.
In November 2023, the FDA sent a letter to healthcare providers reminding them of this fact. The agency required Becton, Dickinson and Company (BD), the manufacturer of GalaFLEX and Phasix, to update the labeling on those products to disclose that they have not been determined to be safe or effective for use in breast surgery.
For the women who had surgery before those warnings, the new disclosures came years too late.
A Former Insider Raised the Alarm
The breast mesh story took on new urgency in late 2025 when Dr. Hooman Noorchashm, a former medical director and safety monitor at BD, went public with disclosures about his time at the company. Dr. Noorchashm has stated that he raised internal concerns about GalaFLEX while at BD, including concerns about breast cancer recurrence in clinical trial patients that he alleges were not adequately reported to the FDA. He has since filed formal petitions with the agency raising further concerns about how these products were marketed for use in the breast.
His disclosures have added fuel to a litigation that was already gaining steam, and they have given plaintiffs’ attorneys an important window into what manufacturers may have known internally about the risks of their products.
What Products and Manufacturers Are Involved?
The breast mesh products at the center of the litigation include:
- GalaFLEX
- GalaFLEX 3D
- GalaFLEX 3DR
- GalaFLEX Lite
- GalaFORM
- GalaSHAPE Scaffolds
- Phasix Mesh
- Phasix ST
The lawsuits allege that BD and its Bard and Davol subsidiaries promoted these products for breast surgery, profited from a market they were never authorized to enter, and failed to warn surgeons and patients about the risks of using mesh in the breast.
What Injuries Are Women Reporting?
A 2021 clinical review found that more than one in three women who received mesh in breast surgery experienced complications. A more recent review found that roughly one in ten patients required additional surgery just to deal with mesh-related problems, and about three percent lost their breast implant entirely because of mesh failure.
The injuries most commonly reported in breast mesh cases include:
- Chronic and recurring infections that do not respond to antibiotics
- Mesh that does not dissolve on the schedule women were promised
- Mesh migration, exposure, or erosion through the skin
- Reconstruction failure and implant loss
- Persistent fluid buildup (seroma) requiring drainage or surgery
- Capsular contracture, the painful hardening of scar tissue around the breast
- Tissue death (necrosis) and skin breakdown
- Chronic pain and nerve injury
- Permanent scarring and disfigurement
- Interference with mammograms and other breast imaging
- Multiple revision or removal surgeries
For women who underwent reconstruction after a mastectomy, these injuries can be devastating. After surviving breast cancer treatment, many of them have been forced to go back under the knife multiple times to deal with mesh-related complications.
What are Breast Mesh Lawsuits Worth?
It is too early to predict specific settlement values. The breast mesh litigation is still in its early stages, no federal multidistrict litigation (MDL) has been established, and no class action has been certified.
What the litigation does have, however, is a clear set of precedents, and the most important one involves the same company. In 2024, BD settled approximately 38,000 hernia mesh cases involving its C.R. Bard products for an amount estimated to exceed $1 billion. The transvaginal mesh litigation, which involved similar polypropylene and biologic mesh products used in women, produced billions of dollars in global settlements paid by Boston Scientific, Ethicon, C.R. Bard, Coloplast, and other manufacturers.
Breast mesh cases are expected to follow a similar trajectory, with the women who file early typically best positioned to shape the litigation and the eventual settlement framework.
How Long Do You Have to File?
Every state has its own statute of limitations, and the deadlines can be short. In California, a product liability claim must generally be filed within two years of the date the injury was discovered or reasonably should have been discovered.
Because breast mesh complications often develop months or years after surgery, the discovery rule can be critical. If you have started to suspect that mesh may be the source of your symptoms, the clock may already be running. Waiting can permanently extinguish an otherwise valid claim.
Frequently Asked Questions
Which breast mesh products are involved in the lawsuits?
The products under investigation include GalaFLEX, GalaFLEX 3D, GalaFLEX 3DR, GalaFLEX LITE, GalaFORM, GalaSHAPE, Phasix Mesh, and Phasix ST, all made or sold by Becton, Dickinson and Company through its C.R. Bard, Davol, and Galatea Surgical entities. None of these products has been approved by the FDA for use in breast surgery.
Is GalaFLEX supposed to dissolve?
That is the claim. GalaFLEX is marketed as a bioresorbable scaffold that supports the tissue while the body heals and then breaks down, with resorption described as essentially complete within 18 to 24 months. Women who have brought claims report complications that continued well past that window, and the lawsuits allege the mesh does not resorb the way it was advertised to.
Is there a breast mesh class action or MDL?
Not yet. As of mid 2026, no federal multidistrict litigation has been established and no class action has been certified for breast mesh injuries. Individual lawsuits are being filed across the country, and consolidation into an MDL or coordinated proceeding is widely expected as case volume grows. Women who file early are typically best positioned to shape the litigation and the eventual settlement framework.
Do I need to know which mesh product was used in my surgery to file a claim?
No. Most patients are not told which mesh product was used. The operative report from your surgeon or hospital will typically identify the manufacturer and product, and an attorney can help you obtain those records as part of the case evaluation.
How long do I have to file a breast mesh lawsuit?
The deadline depends on your state. In California, a product liability claim must generally be filed within two years of the date the injury was discovered or reasonably should have been discovered. Because breast mesh complications often develop months or years after surgery, the discovery rule can be critical. If you suspect mesh is the source of your symptoms, the clock may already be running, and waiting can permanently extinguish an otherwise valid claim.
Frequently Asked Questions
Which breast mesh products are involved in the lawsuits?
The products under investigation include GalaFLEX, GalaFLEX 3D, GalaFLEX 3DR, GalaFLEX LITE, GalaFORM, GalaSHAPE, Phasix Mesh, and Phasix ST, all made or sold by Becton, Dickinson and Company through its C.R. Bard, Davol, and Galatea Surgical entities. None of these products has been approved by the FDA for use in breast surgery.
Is GalaFLEX supposed to dissolve?
That is the claim. GalaFLEX is marketed as a bioresorbable scaffold that supports the tissue while the body heals and then breaks down, with resorption described as essentially complete within 18 to 24 months. Women who have brought claims report complications that continued well past that window, and the lawsuits allege the mesh does not resorb the way it was advertised to.
Is there a breast mesh class action or MDL?
Not yet. As of mid 2026, no federal multidistrict litigation has been established and no class action has been certified for breast mesh injuries. Individual lawsuits are being filed across the country, and consolidation into an MDL or coordinated proceeding is widely expected as case volume grows. Women who file early are typically best positioned to shape the litigation and the eventual settlement framework.
Do I need to know which mesh product was used in my surgery to file a claim?
No. Most patients are not told which mesh product was used. The operative report from your surgeon or hospital will typically identify the manufacturer and product, and an attorney can help you obtain those records as part of the case evaluation.
How long do I have to file a breast mesh lawsuit?
The deadline depends on your state. In California, a product liability claim must generally be filed within two years of the date the injury was discovered or reasonably should have been discovered. Because breast mesh complications often develop months or years after surgery, the discovery rule can be critical. If you suspect mesh is the source of your symptoms, the clock may already be running, and waiting can permanently extinguish an otherwise valid claim.
Talk to an Experienced Mesh Lawyer
Breast mesh litigation is technically complex. It involves overlapping FDA regulatory issues, off-label promotion, and the same families of mesh products that have already been the subject of two major mass torts: the transvaginal mesh litigation and the hernia mesh MDLs.
That history matters when choosing counsel. The California product liability attorneys at Doyle APC have represented hundreds of women in the transvaginal mesh litigation against Ethicon, C.R. Bard, Boston Scientific, Covidien, Coloplast, and American Medical Systems, and the firm currently represents patients in active hernia mesh cases against the same C.R. Bard and Davol entities now named in breast mesh investigations. With more than 28 years of complex product liability and mass tort experience, the firm is investigating GalaFLEX, Phasix, and other internal bra cases on behalf of women nationwide.
If you or a loved one had a breast surgery involving mesh and later experienced infection, reconstruction failure, chronic pain, or a revision surgery, you may have a claim. Doyle APC offers free, confidential case evaluations and represents all clients on a contingency fee basis, meaning there are no upfront costs and no fee unless there is a recovery.
Learn more about your legal options and request a free case evaluation from Doyle APC.
Chris W. Cantrell is a principal attorney at Doyle APC and has practiced product liability and mass injury law since 2003. Mr. Cantrell has personally represented hundreds of women injured by surgical mesh implants, including those by C.R. Bard and BD.
