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.
En la cirugía de tira se extraía cabello de donante de la zona de mayor densidad en la parte trasera y a los lados de la cabeza, áreas menos probables de verse afectadas por la pérdida genética de cabello asociada con la alopecia androgenética (AGA) a medida que los pacientes envejecen. Requería que el médico tuviera la habilidad para usar un bisturí, entender la anatomía del cuero cabelludo, y conocer los principios de sutura. También dejaba una cicatriz lineal, que por lo general se ocultaba fácilmente con el cabello que caía sobre esta, pero la cicatrís podía ensancharse y limitar la capacidad de los pacientes para usar su cabello muy corto. Esta técnica de extracción de zona donantes y los injertos de unidad folicular constituyeron la vieja técnica obsoleta del punzón o punch (apariencia de cabello de muñecas). El equipo de técnicos tenía que estar bien capacitado para manejar los injertos, para evitar daños o destrucción durante el proceso de disección. A medida que los tamaños de las sesiones de injerto se volvieron más y más grandes, los médicos capacitaron a más personal y delegaron la colocación del injerto con el fin de mejorar la eficiencia del procedimiento de restauración capilar.
Desafortunadamente, cuando algunos médicos también comenzaron a permitir que sus técnicos practicaran la cirugía haciendo incisiones quirúrgicas en la zona del receptor para la colocación del injerto (argumentando que un pinchazo de aguja no era una incisión), permitieron que técnicos ilegales se convertiesen en cirujanos de trasplante capilar «express» no autorizados o ilegales. Los asistentes éticos entendieron que estaban ayudando a sus cirujanos, y entendieron que no tenían licencia médica para participar en la realización independiente de procedimientos médicos. Sin embargo, otros asistentes capacitados decidieron capitalizar aún más sus habilidades y comenzaron a contratar de forma independiente a médicos, algunos de los cuales no pudieron realizar la cirugía de restauración capilar ellos mismos.
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?
Hace aproximadamente una década, una «nueva» técnica comenzó a ganar popularidad. Hoy se la conoce como FUE (escisión de la unidad folicular). Implica el uso de un micropunzón de 1 mm o menos de tamaño, para extirpar unidades foliculares capilares individuales o agrupaciones. No implicaba cortar con un bisturí o suturar, pero en realidad creó áreas más grandes de heridas en la piel al producir miles de escisiones pequeñas pero abiertas, de grosor completo, en el cuero cabelludo, dependiendo de la cantidad de injertos necesarios o planeados para una cirugía dada.
Fue promocionada y aceptada como «mínimamente invasiva» porque no creaba la única herida abierta de mayor tamaño, que la elipse dejaba durante el transcurso de la cirugía. Debido a que no requería del conocimiento para utilizar un bisturí, o la experiencia para suturar, era más fácil para los técnicos y vendedores argumentar que no era una «cirugía real». Esto, por supuesto, no es cierto. Las incisiones de grosor completo en el cuero cabelludo para extirpar el tejido del injerto son cirugía..
La necesidad de administrar anestesia local en grandes áreas del cuero cabelludo, y largas sesiones de cirugía de más de 4 horas, así como la necesidad de tomar decisiones médicas analíticas sobre la densidad de la extracción del área donante a medida que se aborda cada centímetro cuadrado, hace claramente que este sea un procedimiento quirúrgico que requiere experiencia médica para poder llevarlo a cabo de forma segura y correcta. Sin embargo, la técnica FUE de la extracción con micropunción facilitó que algunos médicos que no deseaban aprender esta técnica, o que no podían realizarla, decidieran delegarla a personal técnico sin licencia.
Se alentó a algunos médicos a unir fuerzas con hombres de negocios para que deliberadamente delegaran la cirugía a técnicos sin licencia y no regulados. Al permitir que los técnicos hicieran el trabajo en varios pacientes a la vez, podían obtener mayores beneficios. En algunos lugares, permitir que técnicos sin licencia y no regulados realizaran cirugías, incluso bajo supervisión, hizo que gente común y corriente sin capacitación creyeran que ellos también podían realizar la cirugía, usando el nombre y la licencia de un profesional médico y realizando la cirugía por ellos o, a veces, ¡sin un profesional médico con licencia en absoluto!
Hay muchos países donde existe un Mercado Negro de cirugía de restauración capilar. La seguridad de los consumidores para cualquier bien y servicio, incluidos los procedimientos médicos, es tan buena como el gobierno encargado de proteger los intereses del público. Algunos gobiernos y reguladores están haciendo la vista gorda e ignorando los riesgos para la seguridad del paciente.
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?
La Sociendad Internacional de Cirugía de Restauración Capilar (ISHRS) es una organización internacional, pero no es un organismo regulador. Durante varios años, ha expresado su preocupación sobre las prácticas no autorizada de la medicina en la cirugía de restauración capilar, problema conocido por los organismos regulatorios de todo el mundo. Sin embargo, a menudo sucede que los reclamos de los pacientes reciben mucha más atención que los reclamos de los médicos. Incluso ahora, con una cantidad creciente de reclamos de pacientes sobre los resultados de las cirugías del Mercado Negro, como se señaló anteriormente, una respuesta regulatoria es tan fuerte como los gobiernos que supervisan las regulaciones y las hacen cumplir.
Desafortunadamente, incluso algunos reguladores y legisladores están influenciados por presiones o problemas que, sorprendentemente, pueden no poner la seguridad del paciente como la máxima prioridad. Dicho esto, las demandas legales contra médicos que han delegado indebidamente la cirugía de un paciente a técnicos están teniendo su curso en los sistemas legales de EE. UU. y el Reino Unido, y como esta práctica fraudulenta está obteniendo más atención regulatoria, hay esperanza de que se reafirme el paradigma regulatorio que protege a los pacientes.
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.
Revise la siguiente lista de verificación cuando decida hacerse una cirugía con un médico o clínica en particular, para reducir los riesgos asociados con clínicas del Mercado Negro.
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?
La ISHRS promueve «Cirujanos que realizan cirugía» (Surgeons performing surgery), y requiere que los miembros firmen un acuerdo para dar fe de su adhesión a nuestra norma de mejores prácticas, en la que los médicos u otros profesionales médicos con licencia que operen dentro de su ámbito de práctica, realicen todas las incisiones quirúrgicas y escisiones. Dicho esto, dichos acuerdos dependende un sistema de honor, y la ISHRS no puede garantizar que un miembro que firme el acuerdo realmente lo cumpla.
En su lugar, se alienta a los pacientes a preguntar al médico sugerido quién realizará sus escisiones de injerto y las incisiones del sitio del receptor, y cuáles son sus credenciales de no ser esta persona el médico mismo. Si el médico le dice que va a delegar la cirugía, la persona a la que se le delega la cirugía debe ser un profesional médico con licencia legal. Si están delegando la cirugía a un técnico sin licencia y no regulado, usted debe determinar si esto es legal en su área. Si la delegación es legal, usted debe solicitar evidencia de que su médico tenga suficiente experiencia en cirugía de restauración capilar como para delegar y supervisar a su técnico. También debe asegurarse de que su médico no esté usando fotos de «stock» de una empresa de dispositivos médicos, u resultados de otros médicos, y que cualquier cartera de resultados refleje las habilidades y la capacidad del cirujano con licencia que realizará su cirugía.
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.
Desregulación de la profesión médica: hay intereses del Mercado Negro en juego en este campo, con personas que creen que la licencia médica no es necesaria para la práctica de la medicina. Si el público apoya la necesidad de una revisión ética de los médicos a través del proceso de educación médica, y de supervisión regulatoria para aquellos a quienes tienen el privilegio de operar o proporcionar medicamentos, y apoya el requisito de conocimiento adecuado sobre condiciones médicas relacionadas o no relacionadas que contribuyan a algunos casos de pérdida de cabello, instamos a los pacientes a rechazar el paradigma del Mercado Negro. Los instamos, por su propia seguridad y la seguridad de otras personas, a enviar un mensaje a los piratas del Mercado Negro de que no se convertirán en su próxima víctima, ¡y a evitar que esos piratas reduzcan las normas de seguridad del paciente y a que se trasladen a otras áreas de la atención médica!
Comparta su historia
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.
Para obtener más información sobre qué es un Mercado Negro, consulte esta página.
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