What You Should Know About GalaFLEX Mesh (Also Known as the “Internal Bra”)

If you’ve had breast surgery either for cosmetic reasons or after breast cancer you may have had a product called GalaFLEX mesh placed in your body.

Surgeons sometimes describe it as an “internal bra,” designed to help support breast implants or shape after surgery. Some patients may have had good experiences with it. But others are only learning after the fact that this mesh was used and they weren’t fully informed about the risks.

That’s why we want to help patients understand what GalaFLEX is, what the FDA says, what questions you have the right to ask and what you can do about it.

Why This Matters

• GalaFLEX is not approved by the FDA for use in breast surgery.

• The company that makes GalaFLEX updated its labeling to reflect that its safety and effectiveness in breast surgery or breast cancer patients has not been established.

• Doctors who use it this way are doing so “off-label,” which means the FDA hasn’t reviewed this specific use.

• It’s not considered the standard of care in breast reconstruction or cosmetic surgery.
  

Some surgeons may use mesh to potentially improve outcomes. Patients must be told ahead of time about the risks and be given the chance to decide.

What the FDA Says

In November 2023, the FDA issued a warning letter to healthcare providers stating:

“The FDA is aware of increased use of surgical mesh products in breast surgery. However, the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

This doesn’t necessarily mean every use of mesh will cause harm but it does mean patients should be fully informed about potential risks and experimental use before surgery.

Were You Told?

Many women don’t find out GalaFLEX was used until after surgery, sometimes years later.

If you had:

• A breast lift

• A breast augmentation

• Reconstruction after mastectomy

...there’s a chance mesh may have been used without clear discussion beforehand.

What If You’ve Had Complications?

Some people with breast mesh may not have serious problems. Some patients have reported chronic pain, swelling or scar tissue, infection, or a recurrence of cancer.

If this has happened to you, you are not alone, and it is okay to speak up.
Read more

What You Can Do

If you have questions or concerns, you can reach out to:
📍 Website: SafeMedicalDevices.org
📩 Email: contact@safemedicaldevices.org

You can also ask your surgeon for a copy of your operative report, which will tell you what materials were used during your procedure.

You Deserve Full Transparency

BISA wants to keep women safe, healthy and informed. We believe no one should wake up with a medical device in their body they didn’t agree to. You deserve clear, honest information before any surgery, especially when it involves something that hasn't been fully studied for safety.

Innovation is important, but we will keep advocating for strong warnings, better informed consent, and accountability for all patients.

Resources & Additional Reading

Amy J. Reed Collaborative for Medical Device Safety

FDA: Labeling Updates for BD Mesh Products - Letter to Health Care Providers

Medium - Have You Experienced a Complication or Breast Cancer Recurrence After Breast Surgery Using GalaFLEX Mesh, or the “Internal Bra”?

RAPS - FDA highlights updated labeling for some surgical mesh products, cautions against use of mesh in breast surgery

The Bleeding Edge (Netflix)
A gripping documentary that investigates the dark side of the medical device industry—including breast implants.

Disclaimer: This article is for informational purposes only and does not constitute medical or legal advice. Patients should consult with their healthcare providers for individualized care decisions.

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The Breast Implant Safety Alliance (BISA) is the largest organization of board-certified patient advocates and subject matter experts in the world dedicated to patient and consumer safety relating to breast implants. Representing the millions of individuals worldwide that currently have, had, or are considering breast implants, the alliance is a non-industry funded leading authority dedicated to providing balanced, evidence-based information for informed decision making about breast implant surgery and related issues. Founded in 2019 by women, BISA is a grassroots nonprofit organization led by volunteers who do not receive a salary for their work. 

For questions, please contact Jennifer Cook, Director of BIA-ALCL Advocacy. Email her directly at jennifer.cook@bisanonprofit.org.