"Internal Bra" Mesh Complications? See If You Qualify.
If GalaFLEX or other breast mesh left you with pain, fluid, infection or another surgery, use this form. You may be eligible for compensation.
Quick eligibility check
Mesh Was Meant to Support. Sometimes It Doesn't Stay Put.
A scaffold placed to hold tissue.
A thin woven mesh is placed under the skin to support soft tissue after breast surgery.
Cleared for other repairs.
The FDA cleared this kind of mesh to reinforce soft tissue. It says safety for breast surgery has not been determined.
Mesh can shift.
If the scaffold moves or folds, it can be felt, seen or cause pain.
Fluid can collect around it.
A seroma or hematoma near the mesh may need drainage or another procedure.
Infection can follow.
An infection or abscess around mesh can require treatment or removal.
What happened after your surgery?
Infection. Mesh that moved. Fluid. Another operation. Tell us what happened and start your free review.
Free Case ReviewThe FDA says no surgical mesh is cleared for breast surgery.
The FDA says no surgical mesh is cleared or approved for breast surgery. Lawsuits say GalaFLEX was sold for it anyway.
Problems patients report after breast mesh.
Lawsuits describe pain and nerve pain, swelling and fluid that collects around the mesh, infection, breasts that sag or change shape, and mesh that did not dissolve the way patients were told it would. Many needed another surgery to remove it.
These are allegations and patient reports, not proof that the mesh caused a particular injury. The FDA has not recommended removing mesh from people without symptoms. An attorney can review what happened to you.
What the FDA and the studies say.
GalaFLEX was cleared in 2014 to reinforce soft tissue. That clearance does not include breast surgery. In November 2023 the FDA told doctors that no surgical mesh is cleared or approved for breast surgery, and that its safety there has not been determined.
A 2018 study followed GalaFLEX patients for one year and reported good overall results alongside device-related problems, with no comparison group. A 2025 study of 60 breast-lift patients reported better shape with GalaFLEX. Small studies of one product cannot settle what happened to you.
He Warned Them About Breast Mesh. He Says They Fired Him.
A dramatization of a former safety officer's account.
His fight began with his wife.
A power morcellator spread his wife's hidden cancer during routine surgery. Dr. Hooman Noorchashm set out to get it off the market. Device safety became his life's work.
Inside the company.
In 2022 he joined Becton Dickinson as a medical director and safety officer. Becton Dickinson sells GalaFLEX, a mesh cleared to reinforce soft tissue, and surgeons had been using it in breast surgery as an "internal bra." He says he warned that the material might raise the risk of cancer returning after breast reconstruction, and that a study had recurrences no one reported. He says the warnings went nowhere while the mesh kept selling for a use the FDA never cleared.
Out within six months.
He says Becton Dickinson fired him within six months of raising those concerns. He has sued the company in New Jersey, claiming he was let go in retaliation for pushing for stronger testing and disclosure. Becton Dickinson denies these allegations.
He took it to the FDA.
In February 2023 he petitioned the FDA to review the GalaFLEX 3DR, alleging Becton Dickinson had built and promoted it as an internal bra without saying so. He asked the SEC to examine how Becton Dickinson handled the product. That November the FDA told doctors that no surgical mesh is cleared or approved for breast surgery, and that its safety there has not been determined.
And he took it public.
He has kept speaking out about GalaFLEX in the press, warning surgeons that its use in breast reconstruction has no dedicated safety data. No court has ruled on his claims, and the FDA has taken no enforcement action against Becton Dickinson.
Then the patients came forward.
In April 2026 two women who say GalaFLEX left them with nerve pain, swelling, fluid and mesh that would not dissolve sued Becton Dickinson and its subsidiaries in Rhode Island. Both needed surgery to remove it. Their cases are at an early stage, and the allegations are unproven.
Had GalaFLEX or "internal bra" mesh?
If you had pain, fluid, infection or removal surgery after breast mesh, you may be eligible for compensation. Use the form on this page to start a free review.
Free Case ReviewRegulatory and court history
From clearance to the courtroom
How a mesh cleared for other repairs ended up in breast surgery, and in lawsuits.
Illustrations, not actual records.
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May 2014
Cleared for other repairs
GalaFLEX is cleared to reinforce soft tissue. The clearance does not include breast surgery.
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July 2021
Becton Dickinson buys the maker
Becton, Dickinson and Company acquires Tepha, maker of the material in GalaFLEX.
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2022
A safety officer raises concerns
Becton Dickinson's new medical director and safety officer says he warned about the mesh and was fired within six months. Becton Dickinson denies his account.
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February 2023
A petition to the FDA
He asks the FDA to review GalaFLEX 3DR, alleging it was designed and promoted as an "internal bra."
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November 2023
The FDA warns doctors
The FDA says no surgical mesh is cleared or approved for breast surgery, and its safety there has not been determined.
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November 2025
His warnings go public
News reports carry his concerns about GalaFLEX in breast reconstruction, and Becton Dickinson's response.
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April 2026
Patients go to court
Two women sue Becton Dickinson, Bard, Davol, Tepha and Galatea in Rhode Island over pain and removal surgeries. The cases are at an early stage.
Pain, fluid or another surgery after breast mesh? You may be eligible to seek compensation.
Sources
Public records and reporting this page draws on. Claims in lawsuits and petitions are allegations; Becton Dickinson denies them.
- News reportThe Cancer Letter cancerletter.comDr. Amy Reed and the fight over power morcellationMay 26, 2017
- Federal docketRegulations.gov regulations.govCitizen petition on GalaFLEX 3DR (FDA-2023-P-0916)Feb 15, 2023
- FDA letterU.S. Food and Drug Administration fda.govLabeling updates for BD mesh productsNov 9, 2023
- News reportAboutLawsuits aboutlawsuits.comFormer Becton Dickinson medical director's GalaFLEX warningsNov 14, 2025
- News reportAboutLawsuits aboutlawsuits.comFirst GalaFLEX lawsuits filed in Rhode IslandMay 5, 2026
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