What are some key standards for appropriate hair restoration surgery procedures?
Paul J. McAndrews, MD: Considering the cosmetic and medical risks of a hair transplant surgery, the “Critical-to-Quality Steps (CTQS)” of the hair transplant surgery were developed. The CTQS should not be delegated to a medical assistant (MA) or licensed medical professional, such as a physician assistant (PA) or nurse practitioner (NP), practicing outside their scope of training or unsupervised. The CTQS are defined as the steps properly trained physicians are required to perform and include:
- Proper evaluation at consultation, establishing proper consent and expectations, and making the correct diagnosis at the initial evaluation, and finally pre-op clearance.
- Assessment and administration of anesthesia.
- Assessment and administration of sedation.
- Donor harvesting via surgical removal of tissue via strip excision or punch excision.
- Recipient site creation via surgical incisions.
The provision of the Medical Practice Act (Business and Professions Code sections 2053.5) states that a person that is not a licensed physician is in violation of BPC section 2052 if he/she- a) “conducts surgery or any other procedure on another person that punctures the skin or harmfully invades the body.”
In FUE and FUT hair transplant surgery, the excision of tissue from the donor region and the recipient site incisions performed in all hair transplant surgeries not only goes through deeper levels of the epidermis, but goes through the dermis, and must go into the subcutaneous tissue to obtain the transplantable hair follicle, which causes significant bleeding. This inevitably leaves a scar and does sever nerves and vessels. The amount of scar tissue left in the donor region is proportional to the number of times the FUE motorized surgical drill is used to cut out pieces of scalp; the more FUE grafts taken, the more the scar tissue. These steps in the hair transplant process by definition constitute surgery. Unfortunately, some FUE medical device companies deceive some doctors into believing that after they buy this FUE motorized surgical drill that they can delegate these steps of hair transplant surgery to hair transplant technicians. Hair transplant technicians are medical assistants (MAs). MAs do not have to graduate from any school (even high school), do not have to pass any test, and are not licensed/certified by any medical governing body. A medical device company has no authority to provide MAs medical licenses to practice medicine. However, some FUE medical device companies are deceiving the public and doctors by giving these MAs certificates stating that they are certified and can be delegated to do these critical aspects of the surgery. This is illegal and probably criminal since it is aiding and abetting the unlicensed practice of medicine.
Several medical boards and societies definehair transplant as a surgical procedure and have delegation policies. (See sidebar)
What do the Boards/Societies Say?
The American Medical Association (AMA) states:
Hair restoration procedures, including surgical excisions, can only be performed by a licensed physician who meets appropriate professional standards and cannot be delegated to other health care professionals. It has been brought to the attention of the AMA by the International Society of Hair Restoration Surgery that some hair restoration companies have been advising physicians that hair restoration procedures, including surgical excisions, can be delegated to non-physician health care providers in their office. This is contrary to AMA policy. The AMA clearly defines surgery to include the incision or destruction of tissues, as well as the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes and needles. Surgical procedures can only be performed by a licensed physician who meets appropriate professional standards and cannot be delegated to other health care professionals.
The Medical Board of California states:
Hair restoration surgery is the practice of medicine in California and may only be performed by properly-trained, licensed physicians and surgeons or licensed allied health care providers authorized to perform such procedures within their scope of practice. Companies may be marketing surgical devices to physicians indicating that hair restoration surgery is a delegable procedure, causing confusion about who may use such devices in California. Physicians may not delegate hair restoration surgery to medical assistants, who are unlicensed individuals with a very limited scope of practice pursuant to Business and Professions Code sections 2069and 2070 and Title 16 of the California Code of Regulations section 1366. Medical assistants may not perform invasive procedures such as creating holes or slits in a patient’s scalp with a needle, scalpel, or other device. No unlicensed person may perform these procedures in California, including those using titles such as hair restoration technician, surgical technician, hair restoration assistant, or any other title. California’s Business and Professions Code section 2052prohibits the practice of medicine by unlicensed individuals, as well as aiding and abetting the unlicensed practice of medicine. Violation can result in a fine of up to $10,000, imprisonment, or imprisonment in county jail for up to a year or both the fine and either imprisonment.
The International Society of Hair Restoration Surgery (ISHRS) states:
Any procedure involving a skin incision for the purpose of tissue removal from the scalp or body, or to prepare the scalp or body to receive tissue, (e.g., incising the FUE graft, excising the donor strip, creating recipient sites) by any means, including robotics, is a surgical procedure. Such procedures must be performed by a properly trained and licensed physician. All FUE harvesting tools, including robotic devices, are considered extensions of the hand of the operator, and as such, all operators of these devices must be physicians.
Physicians who perform hair restoration surgery must possess the education, training, and current competency in the field of hair restoration surgery. The ISHRS believes the following aspects of hair restoration surgery should only be performed by a licensed physician: 1) Preoperative diagnostic evaluation 2) Surgery planning 3) Surgery execution including: Donor hair harvesting, Hairline design, Recipient site creation, and Management of other patient medical issues and possible adverse reactions and 4) Post-operative care.
The ISHRS believes it is unethical for an individual to travel to a state and/or country in which he or she is not licensed and perform the surgical aspects of hair restoration. The ISHRS also believes it is unethical for a doctor to train an individual to perform surgery who is not an accredited health professional licensed to do so. ISHRS members are required to agree to and abide by the ISHRS Code of Ethics and ISHRS Position Statement on Qualifications for Scalp Surgery. Violators will be subject to disciplinary actions.
What are some of the ways that sub-standard or incompletely trained surgeons stand out?
Dr. McAndrews: The most obvious way these doctors stand out is they purchased a FUE motorized surgical drill from a FUE device company and then allow unlicensed hair transplant technicians to perform the surgery while they practice medicine in a different room.
Another red flag is the doctor only performs FUE hair transplant surgery and not FUT hair transplant surgery. There are situations where one technique is the treatment of choice over the other. If a doctor does not have the knowledge of how to perform FUT surgery, this can be very dangerous. There is a saying, “if you only have a hammer, everything looks like a nail.” Unfortunately, some doctors that purchased these “hammers” from the medical device companies don’t know how to use the “hammer” and delegate its use to an unlicensed hair transplant technician. This is aiding and abetting the unlicensed practice of medicine and these physicians could go to jail.
What are the potential consequences of sub-standard hair surgery procedures? Can you roughly order them from most common to least common?
Dr. McAndrews: I always tell my patients the three biggest risks are:
- The grafts do not survive because the mechanics of the hair transplants were incorrectly performed by a poorly trained doctor or delegated to an unlicensed hair transplant technician.
- The grafts do survive and the poorly trained doctor or delegated unlicensed technician did not understand the artistry of the hair transplant surgery, creating an unnatural hair transplant that will disfigure that patient for the rest of his/her life.
- The poorly trained doctor or delegated unlicensed technician completely decimated the donor area with scar tissue from overharvesting with the FUE or FUT surgery leaving an unnatural scarred donor area.
Do trends like non-scalp restoration pose particular or increasing risks?
Dr. McAndrews: A hair/skin graft removed for a hair transplant always creates scars in the donor region. If the donor region is the chest or beard region, there will be scars left in those regions.
The hair follicle keeps the genetics of where you removed it. If the donor area is the chest, the hair will only grow 1-1 ½ cm before it goes into the telogen phase (fall out) for three months. Therefore, the cosmetic results are usually very subpar.
How can properly trained and qualified hair surgeons set themselves apart? How will the Fight the FIGHT (FTF) initiative help?
Dr. McAndrews: A properly trained doctor is someone that not only learned the mechanics and artistry of a hair transplant in their residency or fellowship but applies this knowledge himself/herself and does not delegate the surgery to unlicensed technicians.
The FTF campaign initiative is awakening the public and the medical profession that there are unlicensed technicians performing the hair transplant surgery. This is being promoted by some FUE device companies and unethical physicians for monetary gains. Again, this is not only illegal but could be criminal since it is aiding and abetting the unlicensed practice of medicine.
Fight the FIGHT
Citing concern about the growing risk to patients of unlicensed technicians performing substantial aspects of hair restoration surgery carried out worldwide, the International Society of Hair Restoration Surgery (ISHRS) says that use of unlicensed technicians to perform aspects of hair restoration surgery, which should only be performed by a properly trained and licensed physician, places patients at risk of: 1.) misdiagnosis; 2.) failure to diagnose hair disorders and related systemic diseases; and 3.) performance of unnecessary or ill-advised surgery all of which jeopardizes patient safety and outcomes. There may also be a risk that unlicensed technicians may not be covered by malpractice insurance.
The Fight the FIGHT public education campaign aims to educate the public about Fraudulent Illicit and Global Hair Transplants. The website fightthefight.ishrs.org offers education and guidance from ISHRS member surgeons as well as reports of actual botched surgeries performed by unlicensed technicians and providers.
What should patients look for before undergoing surgery?
Dr. McAndrews: Patients should determine:
- How was the physician trained?
- How long has the physician been performing hair transplants?
- Does the physician actually apply his/her knowledge or does he/she delegate the surgery to a unlicensed hair transplant technician?
- Does the physician teach the residents in hair transplant surgery at a major training university hospital?
- Contact the state medical board in order to see if there are any complaints or sanctions on the physician’s record.
- Ask other doctors and nurses in your community who they would recommend.
- Beware of a doctor that bought a motorized FUE surgical drill from a medical device company. Always ask who will be operative the FUE surgical drill. If the doctor says his hair transplant technician, report him/her to the local authorities and the state medical board.
Can ISHRS surgeons help those who have been botched by other surgeons?
Dr. McAndrews: Most botched hair trained surgery can be corrected and almost all botched hair transplant surgery can be improved by a well trained hair transplant surgeon.