CIGNA CEO’s Dangerous Decision to Reimburse American Breast Surgeons For Use of GalaFLEX in Patients With Breast Cancer — Where Are the FDA Regulators?
David Cordani is the CEO of one of America’s most powerful and largest health insurers.
American health insurance executives like Cordani, hold tremendous power over the health, safety and fate of American patients — and they wield incredible influence as one of the gatekeepers of US public health. Specifically, because their reimbursement decisions affect, both, individual American lives and US public health, in a profound fashion. But, as the saying goes, with great power, comes great responsibility — and Cordani seems to be failing at his.
Let me explain.
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.
Effective 4/15/2025 CIGNA’s executives did exactly such a thing, by unilaterally declaring that the use of an investigational biological mesh device, known as GalaFLEX, is “medically necessary” in breast reconstruction procedures for treatment of patients with breast cancer — using the widely used CPT code 15777 for reimbursement. Prior to the CIGNA decision, the use of GalaFLEX mesh was considered “experimental, investigational, and unproven” by most insurer’s, including CIGNA, and it was not reimbursed. In fact, no insurers, including CMS, currently reimburse surgeons for use of GalaFLEX in breast surgery, on the basis of its investigational status — EXCEPT CIGNA!
You may read CIGNA’s Medical Coverage Policy on GalaFLEX use in breast surgery, HERE.
But CIGNA’s decision to reimburse for the use of GalaFLEX in breast reconstruction is NOT based on any new evidence of safety or efficacy in breast surgery — nor is it in the best interest of patients, whose safety in the healthcare marketplace must be front and center for a company like CIGNA and its CEO, David Cardoni. Rather, it’s almost certain that CIGNA’s decision to reimburse CPT code 15777 for GalaFLEX use is based on the cheaper price of this unproven and non-standard product, which promises to enrich the company and its shareholders by saving on reimbursement expenses for CPT code 15777. The CIGNA decision is also driven by dangerous advocacy by a small group of vocal surgeons, who have served as the mesh manufacturer’s proxies in false marketing of this product in the breast surgery marketplace for years — as well as a group of their patients who’ve been duped into believing that GalaFLEX is needed for their proper and safe care, and whose voice is being abused by bad journalists in infomercials, posing as credible press.
But the verifiable truth is that the GalaFLEX mesh has not been properly tested for safety and efficacy in breast surgery — and especially in patients with breast cancer. In fact, in November of 2023 the US Food and Drug Administration (FDA) stated exactly this in specific reference to GalaFLEX, that “the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”
Additionally, the manufacturer of GalaFLEX itself modified its “Instructions for Use” product label, following this November 2023 FDA letter to stated that:
“The safety and effectiveness of Poly-4-hydroxybutyrate (P4HB) GalaFLEX LITE scaffold, in breast surgery, including in augmentation and reconstruction of the breast, has not been determined by FDA.”
and that,
“The safety and effectiveness of GalaFLEX [] scaffold in the proximity of existing or excised cancer has not been established.”
Moreover, the FDA recently provided the manufacturer what is known as an “Investigational Device Exemption (IDE)”, in order for the maufacturer and its consultant surgeons to perform a clinical trial to test the safety and efficacy of this mesh product for labeled use in breast surgery on “Pre-Market Approval (PMA)” pathway. The fact that FDA provided the manufacturer and user with an IDE for investigational use in patients undergoing breast reconstruction, demonstrates that this product is considered investigational for breast surgery, by both the FDA and GalaFLEX’s manufacturer. Moreover, the fact that manufacturer is seeking a PMA label for use of GalaFLEX in breast surgery to begin with, demonstrates that both the FDA and the manufacturer consider the use of this device in breast surgery to fall into a “significant risk” category — thus, requiring PMA approval to be labeled for such use.
You may read the GalaFLEX manufacturer acknowledgement that this product is investigational and requires a PMA approval for use in breast surgery, HERE.
My own past work with the manufacturer of GalaFLEX, raised serious concerns about the oncological safety of its material content in cancer patients — and led to my retaliatory firing as that company’s medical director and safety officer:
YET, it seems that despite the clear evidence that this cheap and unproven medical device’s safety in breast reconstruction has not been established — and that it is a “significant risk” investigational device, requiring a PMA label from FDA— CIGNA’s executives, including David Cordani, are willing to unilaterally deem it “medically necessary” and reimburse its use in women with breast cancer using a widely used CPT code to obtain payment. As if GalaFLEX’s safety and efficacy in patients with breast cancer has been proven or can be magically achieved by CIGNA’s executive decision to pronounce it “medically necessary” for breast reconstruction— as if GalaFLEX is a standard medical device used by a majority of breast reconstructive surgeons. But this is unsafe and irresponsible corporate conduct by a powerful health insurance company and its CEO, David Cordani, which threatens, both, the integrity of an existing surgical standard of care and of patient safety.
I recently formally communicated with Mr. Cordani and other CIGNA executives about the factual basis for my concern that the company’s decision to reimburse CPT code 15777 for GalaFLEX use in breast surgery is misguided and dangerous to public health, as described above. The company executives refused to have any substantive discussion with me regarding these safety concerns, and instead sent me the following terse deny-defend response, by e-mail:
In the end, perhaps one thing CIGNA is stating about its decision to unsafely reimburse for use of GalaFLEX in breast surgery with CPT code 15777, is true: that it is FDA’s legal mandate and duty to protect the public from false and predatory marketing and unsafe or unproven use of medical devices like GalaFLEX in breast surgery.
BUT, WHERE ARE THE GOOD FDA REGULATORS LEGALLY CHARGED WITH ENSURING THAT POWERFUL HEALTHCARE CORPORATIONS AND THEIR EXECUTIVES ARE NOT POSING A DANGER TO US PUBLIC HEALTH? Perhaps Mr. Kennedy and President Trump will see that their personnel at the Center for Devices and Radiological Health (CDRH) seem to be absent, or asleep at the wheel!
(This Op-ed was first published on May 24, 2025, in memory of Dr. Amy Josephine Reed — whose battle for women’s health and medical device safety will endure, and whose earthly life ended on May 24, 2017).
