FDA posts warning letters to manufacturers of breast binders

The US Food and Drug Administration (FDA) on Thursday issued warning letters to 12 manufacturers and retailers for illegally marketing breast binders to children for gender-affirming surgery. The warning letters focus on companies’ failure to register their devices, which are now considered Class I medical devices.

Breast binders are compression garments worn to help patients recover from mastectomies and used to flatten the appearance of breasts.

These letters were issued on the same day as a Department of Health and Human Services press conference announcing a series of proposed regulatory actions aimed at limiting access to gender-affirming care for minors, including a proposed rule from the Center for Medicare & Medicaid Services (CMS) that would ban hospitals from performing sex change operations for children under 18.

During the press conference, FDA Commissioner Marty Makary announced the issuance of the warning letters regarding the illegal marketing of breast binders for children intended to treat gender dysphoria. These binders are classified as Class I medical devices and are primarily designed to assist patients in recovering from cancer-related mastectomies.

“Breast binders are a Class I medical device with legitimate medical uses such as being used by women after breast cancer surgery. These binders are not benign. Long-term usage has been associated with pain and compromised lung functions, and even difficulty breastfeeding later in life,” Makary said, adding that the warning letters will formally notify companies of these violations and will require prompt corrective actions. “Pushing transgender ideology in children is predatory, it's wrong, and it needs to stop.”

All 12 companies were taken to task for marketing devices that had received the necessary approvals. Each used similar boilerplate language, stating that binders are now considered Class I devices as they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The warning letter to Philadelphia 7 states that “Our review of your firm’s website revealed that you are distributing the UNTAG line of binders, which its manufacturer, Trans-Missie B.V., claims are intended for ‘helping reduce gender dysphoria.’”

The letter also states that, under Section 510 of the Federal Food, Drug & Cosmetic Act, manufacturers of medical devices are required to register annually with the FDA.

“Our records indicate that the binders in the UNTAG line were manufactured, prepared, propagated, compounded, or processed in an establishment that was not duly registered and were not included in a list required by section 510 of the Act. Therefore, the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)),” according to the warning letter.

Nine of the warned firms were based in the US, and two were overseas.

The American Academy of Pediatrics (AAP) urged federal officials to revoke these restrictions on care for transgender youths.

“These rules are a baseless intrusion into the patient-physician relationship,” AAP President Susan J. Kressly said in a statement. “Patients, their families, and their physicians — not politicians or government officials — should be the ones to make decisions together about what care is best for them. The government’s actions today make that task harder, if not impossible, for families of gender-diverse and transgender youth.”

TG Supply; Flux Lab; Gender Bender; Shapeshifter; Marli Washington Design; Tomboyx; Flavant Streetwear; Early Bed; Tomscout; For Them; Philadelphia 7; and Trans Missie BV

FDA posts warning letters to manufacturers of breast binders

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