The “Shocking Truth” Behind Bill Adams’ Dangerous Public Advertising For Off-Label Use of GalaFLEX as the “Internal Bra” in Breast Surgery

For years, Dr. Bill Adams has been advertising the off-label use of GalaFLEX in breast surgery without any adequate proof of safety or efficacy — especially as it pertains to breast cancer diagnosis and progression.

For years, a surgeon-marketeer and paid industry consultant, named William P. Adams Jr. MD, has been advertising the off-label use of a biologic mesh device named GalaFLEX in cosmetic and reconstructive breast surgery.

Dr. Bill Adams is a paid consultant, key opinion leader (KOL), shareholder and MD-advertiser for GalaFLEX’s manufacturer. He has been, for many years, advertising the safety and efficacy of GalaFLEX for use as the “internal bra” in breast surgery and in breast cancer patients — WITHOUT any convincing evidence that this product is safe or effective.

Dr. Adams hasn’t only been advertising this off-label use of GalaFLEX on as an agent of the manufacturer, he’s been implanting this investigational/experiment device, pre-planned, into his own patients undergoing breast surgery — and then publishing his results in so-called “retrospective” analyses, or inadequately controlled “observational” studies, that prove neither safety nor efficacy, properly. It’s safe to say that to date, Dr. Adams has implanted hundreds of women’s breasts with this off-label and investigational/experimental biologic mesh product.

But breast surgery, especially in patients with breast cancer diagnoses, is no joking matter in U.S. public health— and its certainly not an arena for advertisers, marketeers, medical actors, or Pizza connoisseurs with MDs to be market-making! In fact, most reasonable clinicians and regulators understand that in significant-risk clinical areas, like breast surgery for cancer, off-label marketing without any proper evidence of safety and efficacy is dangerous to public health — and when a manfacturer or its agents engage in such market behavior, they are almost certainly engaged in illegal behavior in the U.S.!

The problem with Dr. Adams’ market conduct with GalaFLEX however, isn’t so much that he’s revealing his own off-label use of this device for breast surgery. In fact, U.S. physicians have the license and power to exercise their individual clinical judgements to use FDA regulated medical products, off-label. They can even publish genuine analyses of their off-label practices, retrospectively. And they are certainly free to talk about their preference, proclivities or even their religious zeal for off-label uses and idiosyncratic clinical practices. Though in such cases, they are obliged to properly and fully inform their patients that they are using “investigational/experimental and off-label” products in their care, whose safety and efficacy for the purpose have not been established. Of course, it is a professional expectation that such investigational/off-label clinical treatments we offered with oversight from a local Institutional Review Board (IRB) — especially, when these clinicians plan to routinely offer off-label/investigational treatments. Certainly, if any physicians use off-label or investigational medical devices consistently in the care of many patients, and then plan to publish their results, as Dr. Adams has, the investigator must seek FDA authorization for an Investigational Device Expemtion (IDE). But, it’s unclear whether Dr. Adams’ past investigational work with GalaFLEX in breast surgery was performed with an IDE from FDA — it certainly does not appear so!

But the most serious trouble with Dr. Adams’ conduct is that he is engaged in all of his GalaFLEX related market activities in breast surgery, as a paid agent and consultant to GalaFLEX’s manufacturer. In fact, for about a decade now, he has been persistently promoting the off-label use of this biologic medical device for breast surgery on his vocal plastic surgery advertising platform, along with a few good colleague-marketeers (e.g., Dr. Bruce Van Natta, another BD consultant, GalaFLEX inventor and share-holder). Adams and his colleagues have not been engaging the healthcare marketplace about GalaFLEX use in breast surgery as simply a good faith academic exercise, or just as a private expression of their personal/professional opinion/belief. Rather they have done so in aggressively and unabashedly scripted advertisements as established agents, consultants, Key Opinion Leaders, and shareholders of GalaFLEX’s manufacturer, promoting the off-label and investigational/experimental use of GalaFLEX products in breast surgery in patients. Dr. Adams is, in fact, an agent, promoter of and advertiser for GalaFLEX’s manufacturer — as is his colleague Dr. Van Natta, who is one of GalaFLEX’s inventors.

Not only has Dr. Adams publicly advertised and aggressively encouraged off-label use of GalaFLEX in breast surgery, he has also published his own prospectively planned clinical use of this investigational medical device in breast surgery — using the rubric of a “retrospective” analysis in order to generate publications that promote off-label use of GalaFLEX in breast surgery — while skirting the stringent federal regulatory compliance requirements for performing such pre-planned off-label clinical studies in in the area of breast surgery (i.e., Investigational Device Exemption authorization from FDA). Frankly, it’s not even clear from Dr. Adams’ most recent “retrospective” publication, if an IRB even weighed in on this surgeons’ informed consent activities and requirements, prospectively or retrospectively! The acronyms IRB or IDE do not appear anywhere in Adams’ 2024 retrospective paper. This is a shocking phenomenon in a published American clinical study in a presumably reputable peer review journal — because it could be demonstrating unauthorized human subject investigational work in cosmetic and reconstructive breast surgery patients.

The captioned video in this article is a recent promotional one, produced by Dr. Bill Adams on his media platform, The Plastic Surgery Channel — and it is truly demonstrative of this surgeon-marketeer’s misleading off-label promotional activities regarding off-label GalaFLEX use in breast surgery. But, again, Bill Adams’ marketing activities are being conduct with Adams as a paid agent, consultant, KOL and shareholder of GalaFLEX’s manufacturer — not simply as an academic or public service activity.

In the referenced video, Adams makes several misleading claims about GalaFLEX use as the “internal bra”, in cosmetic and reconstructive breast surgery:

1. Dr. Adams claims that GalaFLEX is “FDA approved”. This is not a true statement! FDA “approval” is an extremely stringent process that requires demonstration of product safety and efficacy in well-designed clinical trials for the indications put forth by the manufacturer. In fact, GalaFLEX is NOT “FDA approved” for breast surgery, or ANY clinical use. What is true is that GalaFLEX is an “FDA cleared” device that was non-stringently passed through FDA’s 510(k) process, whose safety and efficacy in breast surgery have not been established, at all! This is a seemingly subtle difference in regulatory verbiage — BUT, there is an ABSOLUTELY MASSIVE difference between a medical device “approved” by FDA (i.e., using the stringent PMA pathway that requires establishment of reasonable safety and efficacy for any given use) versus a medical device “cleared” by FDA (i.e., using the relaxed 510(k) pathway that does not require demonstration of safety and efficacy for any given use). Dr. Adams conflates, for effect, when he states that GalaFLEX is FDA approved — it is NOT — for any clinical indication!
2. Though Dr. Adams does state that FDA has declared GalaFLEX to be off-label for use in breast surgery, he goes on to downplay, and almost ridicule, the meaning of this off-label declaration for patient safety. Instead, he proceeds to tout the safety and efficacy of GalaFLEX for use in breast surgery — based only on his own personal anecdotal experience and his pre-planned “retrospective” studies and an older single-armed observational study— none of which rise above weak “level 4” safety and efficacy evidence and, as such, do NOT justify promoting GalaFLEX use in breast surgery as a standard approach, by Dr. Adams or any other entity. So, Adams’ overconfidence in stating that GalaFLEX is safe and effective for off-label clinical use in breast surgery is pure unadulterated and dangerous hubris acting in the U.S. public health marketspace.
3. Dr. Adams falsely claims that the P4HB content of GalaFLEX is safe for use in breast cancer patients. This is a totally baseless statement. In fact, the manufacturer of GalaFLEX, and that company’s CEO and the entire cadre of Medical and Scientific Affairs personnel involved with this product’s development, are well aware that P4HB activates a population of cells in the implanted patients (named M2-macrophages) — and that these M2 Macrophages are known in the immuno-oncology scientific/clinical communities to promote cancer growth. The maker of GalaFLEX also knows that the safety on P4HB in breast cancer patients is not known. Therefore, it is imperative that oncological safety of P4HB be definitively proven before ANY clinical use in breast cancer patients. Still, Dr. Adams falsely claims that P4HB is safe in breast cancer patients. But no amount of rhetorical hand-waving by Dr. Adams, or anyone other marketeer of GalaFLEX, will obviate the need for demonstration of oncological safety in both preclinical and clinical studies with the cancer outcomes metric, front and center. Additionally, P4HB’s main mechanism of action in GalaFLEX is to induce dense scar tissue formation in the body. The scarring of breast tissues could make diagnosing breast cancer with surveillance mammography difficult. Dr. Adams fails to properly address this safety concern — and again engages in rhetorical handwaving, using non-data. But, again, the maker of GalaFLEX and its entire Medical Affairs apparatus is 100% aware that P4HB’s powerful scar-inducing characteristic, can interfere with the sensitivity of surveillance mammography in detection of breast cancer, potentially leading to missed or delayed breast cancer diagnoses in some patients.

The truth about GalaFLEX use in breast surgery is far more concerning than Dr. Adams and his cadre of colleagues and collaborators with the GalaFLEX manufacturer, are advertising publicly — to the American plastic surgery community or to breast surgery patients. Therefore, it is my opinion that the likely illegal promotional and clinical conduct exhibited by Dr. Adams, and the GalaFLEX manufacturer, in the public square, should be the subject of far more intense public scrutiny by breast cancer and reconstructive surgery advocates, the press and public health regulators.

The facts that have not been fully delineated by Dr. Adams about GalaFLEX use in breast surgery, are as follows:

1. GalaFLEX was always intended by the manufacturer for use in breast surgery and is made of a recombinant biologic material, made by E. Coli bacteria, named Poly-4-hydroxybutyrate (P4HB) — this device is, in truth, a “combination” biologic-device and should have never been assigned to the 510(k) pathway for clearance by FDA, given its active biologic content and the manufacturer’s original intended use in breast surgery,
2. On the regulatory front, GalaFLEX’s “Indications for Use” label states that it is for use in “soft tissue support and reconstruction”. This indication is TOTALLY distinct from use in “breast surgery or breast reconstruction”, which is a heavily regulated and highly specific clinical practice area — by both FDA and CMS — and which FDA has clarified in a 2023 Letter to Healthcare Providers,
3. GalaFLEX’s P4HB content activates a population of cells (known as M2 macrophages) in the patient’s body that create dense scar tissue and are also positively linked to promoting cancer growth — a fact that is not at all properly addressed with convincing evidence of basic science and clinical oncological neutrality and safety by the manufacturer — though Adams attempts to hand-wave his way out of the oncological safety problem using words in the Discussion section of his 2024 “retrospective” study,
4. The dense scar tissue created when GalaFLEX is implanted in the breast tissues of patients is highly likely to interfere with surveillance mammography/ultrasound and cause missed or delayed breast cancer diagnoses — this potential danger to patient safety has not been adequately studied or quantified by the manufacturer of this medical device or the surgeons who are promoting it, including Adams. Ironically, data presented in one of Dr. Adams’ past papers suggests that GalaFLEX creates radiologic artifacts that interfere with the sensitivity of surveillance mammography — despite Dr. Adams’ protests to the contrary in his most recent publication,
5. GalaFLEX is considered off-label for use in breast surgery by the FDA — and all health insurer (expect CIGNA) consider it “investigational, medically unnecessary” and non-standard for breast surgery. This is because the safety and efficacy of P4HB in breast surgery and in breast cancer patients has not been established and it is not the standard-of-care device used for this purpose by the vast majority of plastic surgeons,
6. The FDA has explicitly stated that the safety and efficacy of GalaFLEX in breast surgery “has not been determined”,
7. Ironically, as recently as 2024, in GalaFLEX’s own “Instructions for Use”, the manufacturer has stated that: “The safety and effectiveness of Poly-4-hydroxybutyrate (P4HB) GalaFLEX [] scaffold, in breast surgery, including in augmentation and reconstruction of the breast, has not been determined by FDA”,
8. Also ironically, as recently as 2024, in the GalaFLEX’s “Instructions for Use”, the manufacturer has stated that: “The safety and effectiveness of GalaFLEX [] scaffold in the proximity of existing or excised cancer has not been established”,
9. GalaFLEX is NOT used as a standard-of-care by the vast majority of plastic surgeons in the U.S. for cosmetic or reconstructive breast surgery — a fact that Dr. Adams and his small cadre of collaborators are fully aware of as they engage in promotion of off-label GalaFLEX use in breast surgery,
10. Prior to August 2022, in likely illegal conduct, the GalaFLEX manufacturer’s powerful marketing arm was actively and directly promoting the off-label use of GalaFLEX for cosmetic and reconstructive breast surgery to surgeons and medical centers across the United States— and it was encouraging unauthorized human subject experimentation in breast surgery using its P4HB products through a network of paid consultant plastic surgeon consultants. Literally, thousands of patients have been implanted with these investigational P4HB-based medical device in their breast tissues, WITHOUT any FDA or IRB oversight — and WITHOUT any proper plan by the manufacturer to ensure that surgical and cancer outcomes in these patients are, at minimum, equivalent to the the existing standard of care in breast surgery,
11. Recently, the FDA confirmed that the use of GalaFLEX in breast surgery is “investigational” and, thus, granted an “Investigational Device Exemption” (IDE) for its use in a non-oncological clinical trial,
12. Recently, the manufacturer of GalaFLEX admitted that the use of GalaFLEX in breast surgery requires FDA approval through the very stringent “Pre-Market Approval” (PMA) pathway — demonstrating the manufacturer’s own understanding that this product’s use in breast surgery is a “significant risk” use and requires more stringent clinical trials to demonstrate safety and efficacy.
13. It is a concern that at least some GalaFLEX brand devices (e.g., GalaFLEX 3DR, K162922) are “misbranded” medical devices — specifically, because the manufacturer did not represent, in their publicly available 510(k) applications to the FDA, their true “intended use” as being the “internal bra”/mastopexy devices for which they were designed, but which they were subsequently marketed for. Certainly, the market promotional activities of Dr. Adams and other manufacturer agents and marketeers, is also demonstrative of this likely misbranding by the manufacturer.

In the end, what is perhaps most tragic in Adams’ GalaFLEX marketing charade is that, in a past life, Bill Adams was a solid academic plastic surgeon and teacher— not a surgeon-marketeer for industry, nor a medical profiteer, nor a stand up comedian - “full throttle”! I suppose time, ego and money, change good doctors into cartoon characters and contorted versions of what they were or could have been.

But Adam’s conduct, now, in publicly advertising and promoting the non-standard, off-label and investigational use of GalaFLEX as the “internal bra” to plastic surgeons and patients, is no joking matter. It’s not only bizarrely reckless, it is potentially dangerous to public health in the breast surgery clinical area— and, it may be demonstrating the illegal “misbranding” conduct of the manufacturer and its agents under the Food, Drug and Cosmetics Act — after all, Dr. Adams and his cadre of surgeon-collaborators are paid consultants, share-holders, inventors or KOLs for the manufacturer of GalaFLEX, and have been for many years.

The reality is that if these folks (i.e., Adams and Co., and GalaFLEX’s manufacturers) were truly interested in good breast cancer outcomes and patient safety, instead of profits, professional ego boosts and glossy advertising — from the beginning of Galatea Surgical’s founding, they would have worked transparently to obtain an FDA approval label on their GalaFLEX products, for use in breast surgery, using the PMA pathway. Instead, these folks skirted all kinds of safety, marketing and regulatory statutes, obtained a fast, and almost certainly “misbranded” 510(k) clearance with an overly general “Indication for Use”, and then started implanting thousands of unsuspecting patients’ breast tissues with the GalaFLEX biologic material, whose safety and efficacy in breast surgery and in breast cancer patients was not, and is not, known.

It’s a tragic day when American physicians and large, putatively reputable American healthcare corporations, care more about fast and glossy marketing and revenue for shareholders, than they do about proper legal conduct, and the safety and efficacy of their products for use in trusting patients — some of whom suffer from already terrible diseases like breast cancer.

Let’s hope some of my old friends in the GalaFLEX manufacturer’s medical affairs and marketing departments have the integrity and decency to see what I’ve been pointing to, and set this product on the right path to protect their company’s reputation as a trustworthy American medical device behemoth— but I know that’ll be a tall order when your paychecks and benefits are on the line!

Hooman Noorchashm MD, PhD.