GalaFLEX Breast Mesh Problems Were Highlighted in Warnings Issued by Former Becton Dickinson Medical Director

In addition to implant failure risks, breast mesh devices may also interfere with detection of recurring breast cancer, according to medical device safety analyst.

A prominent patient-safety advocate and former company insider is warning U.S. plastic surgeons and patients about the off-label use of GalaFLEX surgical mesh in breast reconstruction, indicating that the device’s safety and effectiveness have never been proven and that its use could expose both patients and surgeons to serious risks.

Dr. Hooman Noorchashm, a cardiothoracic surgeon and longtime critic of lax medical-device oversight, says he was fired by Becton Dickinson & Co. (BD) in 2022, after objecting to what he describes as unsafe marketing and investigational use of GalaFLEX mesh in breast surgery.

Having worked directly with the product and its marketing team, Noorchashm says he witnessed how a device originally designed for soft-tissue repair is now being promoted for widespread use in breast reconstruction surgery without FDA approval, proper study or oversight.

The device in question, GalaFLEX, is a biologic surgical mesh made from poly-4-hydroxybutyrate (P4HB), a polymer created using E. coli bacteria. It is designed to strengthen and support soft tissue as it dissolves in the body over time, leaving behind a layer of scar tissue. The mesh was developed for use in abdominal wall and other soft-tissue reinforcement procedures, but has more recently been marketed and used by many plastic surgeons in breast reconstruction and cosmetic augmentation surgeries.

In a series of public letters issued over the last several months, Noorchashm is urging regulators, insurers, and the plastic surgery community to stop the unapproved use of the GalaFLEX product, warning that an increasing number of women are undergoing reconstructive and cosmetic breast procedures with a device that remains investigational under U.S. law.

Amid these public warnings from the internationally recognized medical device safety expert, breast mesh lawsuits are also now being investigated by lawyers, involving allegations that Becton Dickinson and its subsidiary Encapson promoted GalaFLEX for unapproved breast surgery procedures despite knowing the device had not been proven safe or effective. Many of the women implanted with the devices have reported painful breast mesh side effects including painful scarring, inflammation, infection, multiple revision surgeries and even mesh implant removal.

GalaFLEX Concerns Raised by Dr. Noorchashm

According to an open letter to patients and plastic surgeons, which has also been detailed in investigative reports published by NorthJersey.com and Yahoo News, Dr. Noorchashm joined BD early in 2022 as a medical director and safety officer, hoping to improve transparency from within the industry.

However, within six months, he was terminated after voicing concerns that a mesh made from poly-4-hydroxybutyrate (P4HB), the same material used in GalaFLEX, might provoke biological reactions that increase the risk of cancer recurrence in breast-reconstruction patients.

He also alleged that a privately run study involving the material resulted in several unreported cancer recurrences and lacked required federal authorization to use an investigational device. When his warnings were ignored, he filed a whistle-blower lawsuit in New Jersey state court, claiming retaliation for urging stronger pre-market testing and regulatory disclosure.

BD has denied the allegations, saying his account “is not correct” and that his claims “mischaracterize BD’s actions.” A spokesperson said the company encourages employees to speak up and that “patient safety is at the heart of the products we make and the patients we serve.”

Following his departure, BD reportedly suspended an international clinical trial of the P4HB mesh that had been in preparation for breast-reconstruction use. Noorchashm has since petitioned the U.S. Food and Drug Administration and Securities and Exchange Commission to review how BD handled data and marketed its P4HB-based products.

GalaFLEX Cancer Recurrence Risks

After leaving BD, Dr. Noorchashm began issuing a series of open letters warning plastic surgeons, insurers and patients that GalaFLEX is being implanted off-label in women undergoing both reconstructive and cosmetic breast procedures.

He argues that the material’s immune-system interaction can activate M2 macrophages, cells linked to dense fibrotic tissue and, in some studies, tumor-promoting environments. He further warns that the resulting scarring may obscure mammograms or ultrasounds, delaying detection of recurrent breast cancer.

Despite those concerns, he says, some surgeons have marketed GalaFLEX as an “internal bra” or routine implant material, even though it remains investigational for breast surgery. In several of his Medium essays, Dr. Noorchashm accused certain industry consultants of misleading advertising that implies FDA approval and downplays the absence of clinical data.

Calls for Oversight and Patient Transparency

Dr. Noorchashm’s recent warnings intensified after a Cigna policy change in April 2025 that declared GalaFLEX “medically necessary” for certain breast reconstruction procedures. He contends that the insurer’s decision was not based on new safety or efficacy data, but on cost savings, since GalaFLEX is less expensive than traditional biologic materials derived from human or animal tissue.

By authorizing reimbursement for an investigational device, he warns, Cigna may be driving widespread use of GalaFLEX in women undergoing breast reconstruction after cancer, despite the cancer recurrence risks, and the product never being proven safe or effective for that purpose.

“When a powerful health insurance CEO, like David Cordani, makes a decision to reimburse American surgeons for use of a cheap, untested and non-standard medical device, whose safety and efficacy has not been established and is known to be investigational, he is baselessly participating in corrupting standards of medical care — and causing potential harm to unsuspecting American patients.”
-Dr. Hooman Noorchashm

Noorchashm says he personally contacted Cigna CEO David Cordani to explain his concerns about the risks to patients and the ethical implications of promoting unapproved surgical products through insurance policy. He says the company declined to engage in substantive discussion.

For Dr. Noorchashm, the issue is deeply personal. His advocacy for stronger device regulation began after the death of his wife, Dr. Amy Reed, whose cancer was spread by a surgical tool later restricted by the FDA. He says that tragedy exposed the dangers of untested medical technology entering mainstream practice without adequate oversight, a failure he believes is now repeating itself with GalaFLEX.

Surgeons Could Bear Full Liability

Dr. Noorchashm further cautioned that surgeons who use GalaFLEX mesh off-label in breast reconstruction could be assuming complete malpractice liability for any resulting complications.

Since the product has not been approved for that purpose, he says any injuries or delayed cancer diagnoses could be grounds for legal action against the operating physician or hospital, stating:

“When off-label GalaFLEX use is associated with any adverse clinical event or missed breast cancer diagnoses, the burden of liability will strictly fall on the breast recon surgeon and hospital, for breaching a standard of care in use of a non-standard medical device, whose safety and efficacy in breast surgery and in breast cancer patients has not been determined.”
-Dr. Hooman Noorchashm

He argues that the manufacturer and insurers have effectively shifted responsibility away from themselves by labeling the product investigational while promoting or reimbursing its use.

Breast Mesh Lawsuit Investigations

As Dr. Noorchashm’s warnings gain attention, breast mesh lawyers are investigating potential claims over GalaFLEX mesh used in breast reconstruction and cosmetic augmentation procedures.

The investigations focus on whether Becton Dickinson and its subsidiary Encapson failed to warn that GalaFLEX remains an investigational device for breast surgery, and whether it was promoted for unapproved uses despite the lack of FDA approval.

Individuals may qualify for a breast mesh lawsuit if they underwent breast reconstruction or augmentation surgery that involved the implantation of a surgical mesh device and later experienced:

• Implant removal or revision surgery due to mesh failure
• Infection or abscess
• Nerve damage or chronic pain
• Seroma (fluid buildup)
• Capsular contracture
• Mesh migration or displacement
• Implant rupture or reconstruction failure