Regulation and Standardization in the U.S. Hair Transplant Industry
The current state of regulation in the hair transplant industry in the US is in flux. This is the story of the US hair transplant industry as it struggles to come to terms with its wild west past. Fueled by low barriers to entry, tech innovation, cultural factors such as reduced stigma, and powerful social media influence, the industry has exploded in growth. However, the booming industry has highlighted large holes in regulatory protections, with the result that patient safety and quality of outcomes can sometimes be a roll of the dice. In the face of this crisis, the public, the state medical boards, consumer advocacy groups, and honest, ethical medical practitioners are slowly but inexorably marshaling the necessary political will to create meaningful change, to protect the patient from malpractice and to create a standardized industry with consistent quality of care on par with a legitimate surgical specialty.
The state of regulatory and oversight in hair transplantation in the United States is best characterized as a patchwork. For the most part, the authority over the industry rests with the individual states and their medical boards. While the medical board license physicians and can take disciplinary action in the case of unprofessional conduct or malpractice, the important distinction is that there is no agency or governing body with the authority to ensure that a physician is trained or even competent in the specific skills and techniques of hair restoration. The crux of this loophole is known as the “practice of medicine” clause. As long as a licensed MD is ultimately responsible for and supervising the patient, the highly technical and difficult work can be left in the hands of technicians. In fact, in a large number of states, the technicians who do the technical work of extracting the tiny grafts and placing them in the delicate recipient site have no minimum educational requirement, training or certification, despite this being the most important determinant of graft survival in the surgery. The other major oversight authority is the U.S. Food and Drug Administration (FDA), which reviews all devices for safety and efficacy for the specific purpose that they are to be used for. For instance, ARTAS robotic system received FDA clearance in 2011. It is important to note that FDA approval of this robotic arm is for safety and use of the arm for the removal of the grafts, not the technique and skill of the practitioner. This means that a clinic with a doctor on staff can buy this device and with terrible operator skill and poor clinical judgement cause irreparable harm to the patient. The patient now has little recourse and there is a chasm of liability that the surgeon/operator can fall through. The largest and most influential professional societies have in place statements of member ethical standards and publish these for the benefit of potential patients. These societies, International Society of Hair Restoration Surgery (ISHRS) and the American Board of Hair Restoration Surgery (ABHRS), provide a backbone of peer reviewed, evidence based information on the latest techniques, technologies, and treatments, have strict membership requirements, provide continuing education for current members, host conferences to further educate practitioners on surgical ethics and best practices, as well as continuing to promote and expand education and medical standards for new practitioners. This of course, is only a select few organizations and only within the US. Outside of these three, the industry is more or less free to set its own guidelines, advertising practices, and recruitment and training procedures for new surgeons and technician staff.
There are several forces at work that have led to the increased urgency and necessity for reform and regulation. The first and most salient issue is the global phenomenon of hair transplant tourism. The rise of extremely high-volume “hair mills” in Turkey have impacted the US industry directly, often leading to over-harvested donor areas and unshaven hairlines. There has been an increase in the influx of patients requiring difficult and sometimes impossible “repair surgery” after falling prey to international clinics, and US surgeons and medical boards are starting to be flooded with these cases. This, coupled with a new crop of very well educated patients with incredibly high standards due to the online presence of YouTube, the Reddit Hair Transplant community (r/tressless), and forum pages such as thehairlossforum.com, has sharpened the focus on a prevention-based model of regulatory standard in the United States. The patient has never before been more informed. There is no single, simple, correct way to perform a hair transplant, but a “natural” hair transplant should not leave obvious error to the trained eye and should not cause scarring. The other major force is high-profile lawsuits and news articles that have been flooding the public and government arena. Litigation and expensive malpractice suits only increase with the number of procedures being done and can easily bankrupt a clinic and make the owner seek work abroad. The negative press is starting to have an effect and with every new investigative piece that exposes suspect advertising, sales tactics, and botched surgeries, a further nail is hammered into the coffin of the status quo. Articles such as these act as free case studies in regulatory failure and begin to shame both the clinic and the elected representatives who allow such poor regulatory standards.
The push for reform is made up of three pillars. The first pillar is an increase in regulatory oversight and stricter regulations in a proactive manner rather than a reactive one. Reform groups are pushing for standardization of training and certification for technicians. State-by-state mandates for hair transplant technicians to take accredited training courses, accrue a minimum number of supervised procedural hours and take a standardized exam. This will address the most glaring quality control gap by ensuring the person placing the grafts has the requisite skill for that role. A second important piece is the implementation of standard criteria and verification of hair transplant clinic accreditation. The standard used by these groups is the Accreditation Association for Ambulatory Health Care (AAAHC) accreditation that ensures all ambulatory facilities, clinics, and hospitals have certain standards and criteria that are met on a consistent basis. This would serve as an independent quality assurance measure to patient safety. The final piece of increased regulation reform is an active oversight board cracking down and clarifying the definition of “direct supervision”, whereby the physician of record is in the room and present throughout the procedure, not just available for consultation via phone.
The second pillar is arguably the most important of all. Board certification and demonstrable competency by the surgeon. The current system faces a crisis of competency. The patchwork nature of current regulation means that there is no board, society, or governing body in place to ensure that physicians attempting hair transplantation have the necessary surgical skillset. Simply put, any MD in the US is allowed to advertise and perform hair transplantation, regardless of background. Dermatologists are only required to have a minor rotation during residency, and residents from family medicine and psychiatry are virtually untrained in any type of surgery, let alone this highly technical one. The key to closing the competency gap is to make board certification the new gold standard, and then have it be a requirement for advertising or legally being a hair restoration surgeon. The American Board of Hair Restoration Surgery (ABHRS) is the only real certification that exists, and is also an ABMS accredited organization (i.e. meets the requirements set forth by the American Medical Association). It requires its candidates to have an unrestricted medical license and a demonstrable significant volume of hair restoration experience. The surgeon must pass a written and oral examination that tests hair biology, anatomy, technique, principles, instrumentation and surgical ethics. This program is voluntary, and the larger reform community is pushing to make ABHRS board certification (or equivalent) be the required standard. Honorable hair transplant clinics already tout the ABHRS membership of their surgeons and this will become a key qualification that educated patients will seek out. The end goal is for every physician advertising or billing as a hair restoration surgeon to be board certified, just as with other surgical specialties.
The final third is the increasing push for standardized, honest advertising practices. The hair transplant advertising is, and has always been the most maligned and misguiding aspect of the industry. The aggressive sales tactics prey on patient vulnerability and take advantage of their hopes in a slick, simple way. Reform groups in this area are advocating first and foremost, the ban of bait-and-switch pricing models, with false advertising of a very low “price per graft” to get a patient in the door, only to be told in the office that the case is larger and more difficult than advertised and to expect a higher price than the one quoted online. There is also a large push to mandate that the photos being used are not photoshopped, and lighting tricks to artificially brighten or change a patient’s appearance. Rules would be put in place that stipulate all before and after photos be taken with the same lighting, angle, and hair length. In addition, clear and balanced descriptions of technique limitations and possible trade-offs must be displayed, especially with regard to unshaven FUE. This, of course, would be misleadingly marketed as “scarless” and with no downtime. The final reform push in this area is for full transparency on who will be in the operating room for surgery. Marketing materials of an established, “celebrity” surgeon would need to make it explicit as to whether that doctor will actually be performing the procedure or if it will be just a supervising role and a team of technicians will be taking the grafts.
In terms of implementation, there are several large hurdles to jump. The medical community in general is notoriously resistant to outside interference in its practice. There will be significant pockets of backlash from clinics that profit from the current relative lack of regulation. The largest and most influential professional societies have in place statements of member ethical standards and publish these for the benefit of potential patients. These societies, International Society of Hair Restoration Surgery (ISHRS) and the American Board of Hair Restoration Surgery (ABHRS), provide a backbone of peer reviewed, evidence based information on the latest techniques, technologies, and treatments, have strict membership requirements, provide continuing education for current members, host conferences to further educate practitioners on surgical ethics and best practices, as well as continuing to promote and expand education and medical standards for new practitioners. This of course, is only a select few organizations and only within the US. Outside of these three, the industry is more or less free to set its own guidelines, advertising practices, and recruitment and training procedures for new surgeons and technician staff.
The issue of reform and regulation of the hair transplant industry in the US is at a tipping point. The rapid growth and avarice of some clinics has highlighted large holes in regulatory protections, with the result that patient safety and quality of outcomes can sometimes be a roll of the dice. In the face of this crisis, the public, the state medical boards, consumer advocacy groups, and honest, ethical medical practitioners are slowly but inexorably marshaling the necessary political will to create meaningful change, to protect the patient from malpractice and to create a standardized industry with consistent quality of care on par with a legitimate surgical specialty.
In summary, it is of the utmost importance that the US hair transplant industry change its path. It can continue down the road of the Wild West, the result of which will be increasing scrutiny from the public and government arena with expensive lawsuits and medical board actions, further damaging the reputations of the few in the industry that strive to practice in a professional, patient-centric manner and increase malpractice insurance premiums. It can regulate itself, increasing costs and entry barriers. However, the only direction that will have the patient’s best interests in mind and ensure ethical integrity, long-term credibility, and the very survival of this as a surgical specialty is to face the necessary, but difficult path of stricter government regulations, mandatory certification of surgeons and technicians, and standardized, honest advertising practices. These are not a four cornered definition of hair transplant medicine but a vital step in changing its public perception from scam to surgical specialty.
