How did hair restoration surgery become so popular and what contributed to the evolution of a Black Market?
The popularity of hair restoration surgery has emerged in large part due to the innovation and research by physician members of the ISHRS who over a period of decades, developed and refined a surgical technique known as follicular unit transplantation. When properly performed this surgery is safe and effective at reversing the appearance of hair loss and providing natural looking results for patients with androgenetic alopecia (AGA), aka male pattern baldness, and other forms of hair loss.
Initially, this advanced method of donor harvesting involved removing a linear strip of donor hair and skin. The linear ellipse (strip) excision required a team of trained technicians to carefully dissect the naturally occurring hair bundles (follicular units) from the strip of tissue under microscopic dissection. The tiny follicular unit grafts were then re-distributed into tiny micro incisions in the areas of hair loss. This method can recreate the appearance of natural hair coverage when grafts are redistributed in sufficient numbers, sufficiently close together that the eye perceives it as comparable density to what naturally occurred. The strip surgery removed donor hair from the area of greatest density in the back and sides of the head–importantly areas least likely to be affected by the genetic hair loss associated with androgenetic alopecia (AGA) as patients age. It required the doctor have the ability to use a scalpel, understand scalp anatomy and to know the principles of suturing. It also left a linear scar which was usually easily hidden by overlying hair, but which could widen and limit the ability of patients to wear their hair very short. This donor harvesting technique and follicular unit grafts made the old “punch and plug” technique (dolls hair appearance) obsolete. The team of technicians had to be well-trained to handle the grafts to avoid harm or destruction during the dissection process. As graft session sizes became larger and larger, doctors trained more staff and delegated graft placement in order to improve the efficiency of the hair restoration procedure.
Unfortunately, when a few doctors also began to allow their technicians to practice surgery by making surgical recipient site incisions for graft placement—arguing that a needle stick was not an incision—they took one step closer to allowing unlicensed technicians to become rogue or illegal, “overnight” hair transplant surgeons. Ethical assistants understood they were assisting their surgeons and understood they did not have a medical license to engage in independent performance of medical procedures. However, other trained assistants decided to further capitalize on their skills and began to contract independently to doctors, some of whom were unable to perform hair restoration surgery themselves. The latter circumstance was in violation of medical regulations for most jurisdictions. These regulations require a doctor to be adept and knowledgeable about any procedure they would delegate or supervise. Improper or excessive delegation created the foundation for development of a Black Market —where technicians bypassed medical school or other medical professional training or residency programs, licensing and the legal standards imposed by laws and regulations designed for patient protections. The only ‘stumbling block’ was getting a doctor to remove the donor area, which required a scalpel and suturing. This obstruction was removed by the development of a different surgical excision technique to remove donor grafts which today is known as follicular unit excision (FUE), or formerly, follicular unit extraction.
How did the Evolution of FUE (follicular unit excision) promote the Hair Transplant Black Market?
About a decade ago, a “new” technique began gaining in popularity, which today is called FUE (follicular unit excision). It involves the use of a micro punch 1 mm or less in size, to excise individual hair follicular units or groupings. It did not involve cutting with a scalpel or suturing, but actually created larger areas of skin wounding by producing thousands of tiny but open full thickness excisions in the scalp, depending on the graft numbers needed or planned for a given surgery. It was advertised and accepted as “minimally invasive” because it did not create the single larger open wound that the ellipse did during the course of surgery. Because it did not require the knowledge to use a scalpel, or the expertise to suture—it was easier for technicians and marketers to argue it was not “real surgery”. This, of course, is not true. Full thickness incisions into the scalp to excise graft tissue is surgery.
The requirement for administering local anesthesia to large areas of the scalp, and long surgery sessions in excess of 4 hours, as well as the need to make thoughtful medical decisions about density of donor harvesting as each square centimeter is addressed, clearly make this a surgical procedure requiring medical expertise to perform it safely and correctly. Nevertheless, the FUE technique of micro punch harvesting made it easier for some doctors who did not wish to learn this technique, or who were unable to perform it, to decide to delegate it to unlicensed technician staff. Some doctors were encouraged to join forces with businessmen to deliberately delegate the surgery to unlicensed and unregulated technicians. By allowing technicians to do the work on multiple patients at one time, they could realize greater profits. In some places, allowing unlicensed, unregulated technicians to perform surgery, even under supervision, had the effect of fueling lay people with no training at all to believe they too could perform surgery—either using a medical professional’s name and license and perform the surgery for them, or at times, without a licensed medical professional at all!
There are many countries where a Black Market in hair restoration surgery exists. Consumer safety for any goods and services, including medical procedures, is only as good as the government tasked to protect the public’s interest. Some governments and regulators are turning a blind eye and ignoring the risks to patient safety.
If Black Market surgery is cheaper why should patients be worried about it?
Patients should care because of what they are losing and what they are risking. Buying into the hair transplant Black Market isn’t about purchasing a low cost “knock off”. Medical care and medical risks are far different than the purchase of a purse, shoes, or pair of sunglasses. These latter items are disposable, and if the quality does not meet a consumer’s expectations, there is no long-term consequence to making a bad choice. The consequences of a bad hair restoration surgery can vary from minor to severe and even life threatening, and all will last a lifetime.
It is true there is a reduced cost for any surgery without the expensive ‘trappings’ of the medical paradigm. But patients need to know what are the ‘trappings’ that are not included? First of all, eliminating the cost of medical expertise via medical professional school and training is a dangerous choice for many reasons. At the outset, during diagnosis for treatment of the cause of hair loss, the absence of a knowledgeable medical practitioner eliminates the opportunity for a patient with a medically reversible cause to be treated and avoid surgery. It also prevents patients who are not good candidates for surgery—e.g., too little permanent donor hair- to learn this before spending money on an unnecessary, inadequate or failed procedure.
Supporting a Black Market of unlicensed, unregulated technicians also sidesteps medical professional licensing boards who provide oversight and can suspend or revoke licensure for medical practitioners who harm patients. Choosing a Black Market clinic eliminates malpractice insurance costs because such clinics involve people who are not insured or in the case of a token doctor would likely need to lie about their improper delegation model in order to get their insurer to cover an incident. This need for deception permeates the ethics for care that patients receive.
Black market clinics with little or no medical expertise may avoid the costs of required disinfection procedures which, in regulated clinics, reduce infection risks. Perhaps one of the most troubling areas of Black Market cost cutting are the violation of regulations forbidding surgery patients from being operated on in the same room simultaneously, in order to avoid cross contamination of blood born infections such as HIV, Hepatitis C, or spongiform encephalopathy (mad cow disease)—to name a few. Reports of industrial style clinics or “mills” with patients lined up side by side during surgery, pose tremendous cross contamination risks that won’t be revealed for years if they occur. These types of infections could be transmitted to future sexual partners, too.
Black market clinics also do not incur the overhead cost of postoperative follow up with physician oversight to manage problems if things go wrong. This website will share with you the cases of many patients who have experienced what can go wrong with Black Market surgery.
Why aren’t medical regulators doing something about the dangerous Black Market?
The ISHRS is an international organization, but is not a regulatory body. It has for several years made its concerns about the unlicensed practice of medicine in hair restoration surgery known to regulatory bodies around the world. However, it is often the case that patient complaints get much more attention than physician complaints. Even now with a growing number of patient complaints about results from the Black Market surgeries, as previously noted, a regulatory response is only as strong as the government(s) that supervise and enforce them. Unfortunately, even some regulators and lawmakers are influenced by pressures or concerns that, surprisingly, may not place patient safety as the top priority. That being said, law suits against doctors who have improperly delegated a patient’s surgery to technicians are making their way through the legal systems in the U.S. and the U.K., and as this fraudulent practice gains more regulatory attention there is hope that the regulatory paradigm that protects patients will be reasserted.
How can patients tell if they are being courted by a Black Market clinic?
An internet marketer can say most anything to entice a patient. The best evidence that you have identified a real doctor is, first of all, to verify their medical credentials with the local medical professional licensing authority. The ISHRS website can also assist patients to cross reference the name and location of an advertised specialist with the global “Find a Doctor” data base on this website.
Member doctors who have become “Fellows “of the ISHRS have earned this title of recognition by being a longstanding member in this organization, attending meetings and workshops, contributing to education through lectures and publications, and generally establishing their commitment to ongoing education and training in this field. If you do not have an ISHRS member with the designation of “Fellow” near you, you can also request evidence of training in hair restoration surgery, workshop attendance and, finally, review actual before and after results of the doctor’s work.
Review the following check list when deciding to have surgery with a particular doctor or clinic to reduce the risks associated with Black Market clinics.
1) Check with local/regional authorities to insure that any “doctor” advertising for your business is legally licensed to operate in the advertised jurisdiction.
2) Know what your surgeon is supposed to look like, what their experience and training in hair restoration surgery has been, review before and after examples of their work and are not “stock” photos (ask your surgeon to verify this) and make it known that only your surgeon or a licensed professional operating in their scope of practice delegated by your surgeon—with your consent—will be allowed to make any incisions/excisions on your scalp/body.
3) Ask who will be designing your hair line, supervising graft placement, as well as determining anesthetic requirements. All of these tasks require judgements that should be made by your doctor or licensed medical professional operating within their scope of practice.
4) Inquire how many surgery cases will be performed at the same time under your doctors supervision…if there are multiple cases happening, it is likely your surgery is being performed by someone who is not your doctor, and you should know who that is, whether they are licensed to perform surgery, and how they will be held responsible or who will assist you if there are any difficulties in your postoperative course.
Does working with a doctor who is an ISHRS member guarantee that I will have a licensed medical professional doing the surgery?
The ISHRS promotes “Surgeons performing Surgery”, and requires members to sign a member agreement to attest to their adherence to our best practices standard where doctors or other licensed medical professionals operating within their scope of practice, perform all surgical incisions and excisions. That being said, such agreements depend on an honor system, and the ISHRS cannot guarantee that a member who signs the agreement actually abides by it. Instead, patients are encouraged to ask their proposed doctor who will be performing their graft excisions and recipient site incisions—and what are their credentials if it isn’t the doctor. If the doctor tells you they will be delegating the surgery, it should be to a legally licensed medical professional. If they are delegating to an unlicensed, unregulated technician, you should determine if this is legal in your area. If delegation is legal, then you should request evidence that your doctor has sufficient expertise in hair restoration surgery to delegate to, and supervise your technician. You should also make sure your doctor is not using “stock” photos from a medical device company or another doctors’ results, and that any portfolio of results reflects the skills and ability of your licensed surgeon.
What are the risks to patients of using Black Market clinics?
As previously noted there are many risks to being a patient in the Black Market. Photos of some of the devastating consequences will be added to this website as they continue to be sent to us.
Some of the risks such as blood born infections from cross contamination by inappropriately sterilized tools or patient proximity cannot be known unless or until patients are tested for them. But the following are among the risks that are currently being seen with increasing frequency:
Donor Area Overharvesting—moth eaten appearance of the donor area with extensive scarring and permanently reduced density due to the marketing technique of promising potential patients “as many grafts as possible”—but which actually result in taking too many grafts or creating too many holes which turn into scars and damages the donor hair
Donor Area Necrosis: Too many punch holes placed too close together may compromise blood supply to the remaining skin, leaving areas of dead tissue that will scar with no hair
Poor Graft Growth: This may stem from either graft waste (technicians with no oversight may not place all harvested grafts due to time constraints for the next case), or poor harvesting techniques, or improper handling techniques including allowing the grafts to dry out during placement resulting in poor growth
Recipient Area Necrosis: Too many incisions placed to deeply or too close together may compromise blood supply to the skin and result in tissue death in the recipient area
Unnatural Appearing Results: Hair transplants are best performed by a surgeon experienced in designing aesthetic hairlines, instead of by technicians who have minimal to no hairline design training, Furthermore, technicians who practice in an unsupervised setting are illustrating their propensity to work outside legal safeguards that require medical licensure, have no reputation to protect, and have little incentive to provide patients the best result. They also do not typically see patients in follow up to evaluate their results. From their perspective each patient may be just one of many having a procedure that day and their primary goal is to finish the job and move on.
Surgical Infections: In one reported instance a rapidly spreading scalp infection caused the loss of a patient’s eye; other severe scalp infections have been reported to require antibiotic therapy by a licensed medical professional
Deaths: While this procedure has a low risk of complications when properly performed, like any procedure performed with local anesthesia there is a risk of medication toxicity resulting in cardiac arrhythmia, neurologic symptoms such as seizures, and death. Although still infrequent, reports of deaths during or after a hair transplant procedure have seen an uptick in recent years, associated with inexperience or the unlicensed practice of medicine in this field.
Deregulation of the medical profession: There are Black Market interests at play in this field, with people who believe medical licensure is not necessary for the practice of medicine. If the public supports the need for ethical screening of medical practitioners through the medical education process, and regulatory oversight for those given the privilege to operate or provide medications, and supports the requirement for appropriate knowledge of related or unrelated medical conditions that contribute to some cases of hair loss—we urge patients to reject the Black Market paradigm. We urge them for their own safety and the safety of others to send a message to Black Market pirates that they will not become their next victim—and to keep such pirates from reducing standards for patient safety and moving into other aspects of medical care!
Share Your Story
If you have been negatively affected by this Black Market incursion into medical/surgical treatment for hair loss please contact the ISHRS to share your story. If you have been a patient of the Black Market but did not experience a negative outcome, you were lucky, but your support of the Black Market should not be shared with other patients who may suffer the consequences of the unlicensed practice of medicine.
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