When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman.
Berman and his clinic partner, urologist Elliot Lander, run an adipose stem cell firm called California Stem Cell Treatment Center. This clinic seems effectively to also be the HQ of a network of about 100 stem cell clinics called Cell Surgical Network. The FDA described the clinic’s and the network’s adipose cell product as a drug and the agency has not approved its use in patients.
A lengthy FDA warning letter to Berman popped up this week on a different front.
The letter pertains to a breast augmentation-related device meant to deal with a side effect called capsule contracture. The FDA says in the letter that Berman is using this device called the Pocket Protector on patients despite a lack of agency approval. The FDA also has a long list of other more specific issues with the device and practices related to it.
In a press release accompanying the warning letter, FDA Commissioner Dr. Scott Gottlieb used some striking words. Here’s just one sample excerpt from the lengthy PR (emphasis mine):
“This is not the first time the FDA has notified Dr. Berman concerning his illegal marketing of unapproved medical products and potentially putting his patients at significant risk. Dr. Berman is well aware that the FDA has never approved any product to prevent or treat capsular contracture. By illegally manufacturing and marketing this device, Dr. Berman is taking advantage of patients and exposing them to a broad range of unknown health risks, including not effectively preventing capsular contracture as the product claims or causing additional harm such as infection or adverse reactions with the breast implant. We’ll continue our efforts to protect patients from those individuals who choose to skirt laws intended to keep patients safe and sell unproven and potentially unsafe medical products.”
I asked Dr. Berman for comment on the warning letter and Gottlieb’s statement. Here was his response:
“The FDA comments (written by Dr. Gottlieb or one of his associates on his behalf) are nothing short of libelous. I’ve never taken advantage of a single one of these breast patients. They’ve found me through friends and other doctors after desperately trying to find a way to obtain normal breasts after multiple failed surgeries for capsule contracture. I was the first surgeon in the world to use e-PTFE (i.e. “Gore-Tex” known as one of the safest synthetic implant materials) for plastic surgery patients. Over the years, I figured out how to prevent the recurrence of capsule contracture by lining the breast pocket with e-PTFE and preventing it from contracting around an implant. Over time, I was able to get a .3mm thick sheet of e-PTFE with 40 micron porosity made so there would be tissue in-growth without concentric scar tissue formation, thus preventing scarring of a typical breast pocket around an implant. Since 2003, I’ve treated many women with recalcitrant capsule contractures – many had over 5 operations and some as many as 12. They always got firm again – something well-known to the surgical community.
With the device I developed I could finally give women a chance to heal with normal soft natural appearing breasts – even in the most difficult cases. It required a total capsulectomy with implantation of the e-PTFE bladder and an implant.
Gottlieb may think he cares about advancing women’s health, but I actually have patients that have real problems and I actually have to take care of them and, thankfully, because of a little creativity and good engineering, I’m able to do just that. I’ve been working with the FDA for years trying to get this approved for simple IDE studies. The regulations keep growing quicker than I can finish an IDE application.
There is nothing about me that ranks as a “bad actor.” I’m here for my patients and frankly, I think doctors have turned into sheep and we rely on government agencies to make decisions that should be our responsibility. We’ve really lost control of our practices to so many other industries within healthcare. I take the Hippocratic oath seriously – “If you can help your patient, it is your duty to try.” I’m not happy that I can’t get this exceptionally successful product to market. I just don’t have the unlimited funding necessary, but I’m getting closer and still trying.”
The new warning comes on top of Berman already being in the situation with the agency over marketing of unapproved “fat stem cells” (a diverse mixture of adipose tissue-derived cells with a subpopulation that are stem cells) for a variety of health conditions. Berman, Lander, their specific clinic, and Cell Surgical Network are named as defendants in an ongoing lawsuit brought by FDA/DOJ. The suit, filed last May, seeks a permanent injunction against the marketing of the unapproved fat stem cells. In parallel the FDA also sued for injunction against a Florida stem cell firm, US Stem Cell Clinic/US Stem Cell (USRM).
Earlier in August 2017 the FDA also reported that it had seized (via US Marshals) an unapproved drug product consisting of a combination of fat stem cells and smallpox vaccine from a firm working with California Stem Cell Treatment Center. The combo was apparently administered at California Stem Cell Treatment Center according to the FDA.
We’ll see what happens next, but the tension here just went up a big notch.
In my view the agency is almost certain to prevail in court. The permanent injunctions could be in place before the end of this year even with appeals or more likely sometime in the first half of 2020. More broadly, recently the FDA also sent out 20 or so of what I’ve called “mini-warning” letters to other stem cell clinic firms (we don’t know which), advising them that they appear to be out of compliance with the law. Time is running short on these clinic firms as well.
It’s possible we’ll see a wave of clinic firms moving outside the U.S., possibly to the Caribbean or the Middle East, or moving away from marketing fat stem cell injections and perhaps toward cheap, sketchy birth-related “stem cell” products that have flooded the U.S. in the past few years.