Have You Experienced a Complication or Breast Cancer Recurrence After Breast Surgery Using GalaFLEX Mesh, or the “Internal Bra”? If So, Contact SafeMedicalDevices.org

For years, GalaFLEX mesh has been marketed as the “internal bra” for both cosmetic and reconstructive breast surgery in patients with breast cancer. But this medical device’s safety and efficacy in breast surgery has not been established by the manufacturer or the FDA— so, its use in American patients is considered, non-standard, off-label and investigational.

If you are a patient who has undergone a cosmetic or breast reconstructive surgery following a cancer diagnosis, you may have been treated with GalaFLEX mesh by your plastic surgeon. This operation may have been an implant breast reconstruction after mastectomy for cancer, or it may have been called the “internal bra” operation, if your operation was performed for cosmetic reasons.

If you’ve experienced a complication or breast cancer recurrence following your breast surgery with GalaFLEX, you may have been harmed.

Let me explain.

In November 2023, the FDA published a “Letter to Healthcare Providers”, stating that the safety and efficacy of GalaFLEX for use in breast surgery “has not been determined”. In this letter, the FDA confirmed that GalaFLEX use in breast surgery is non-standard, off-label and is, thus, investigational.

Additionally, GalaFLEX is only being used by a small group of plastic surgeons in the United States, because it is cheaper than the standard material used for this purpose. But, GalaFLEX is NOT the standard-of-care in cosmetic and reconstructive breast surgery. In fact, its use is considered off-label and investigational.

Additionally, even the manufacturer of this mesh product has stated that the safety and efficacy of GalaFLEX in breast surgery has not been established — and that its safety in breast cancer patients is unknown.

So, if you have experienced a complication or a breast cancer recurrence after your breast surgery using GalaFLEX, you may have been harmed by the off-label and investigational use of this medical device by breast surgeons. Please contact SafeMedicalDevices.org, at contact@safemedicaldevices.org.

Sincerely,

Hooman Noorchashm MD, PhD.