Clinical updating study at 3 years on 278 patients treated by modern artificial hair implant technique (automatic biofibre®).

In this study, we report our multicentric experience of synthetic medical certified polyamide hair implants in male androgenetic, female menopausal, and chronic alopecia. Biofibre hair implantation was performed by means of a standardized, mini-invasive technique followed by regular postoperative care along 3 years. From May 2015, 278 patients were enrolled and 253 completed the trial; 202 men (79.9%) versus 51 women (20,1%). The average age was 43(± 4.29); 179 patients (70.1%) had taken previous treatments for alopecia. We evaluated efficacy (as judged by Hamilton scale grading, covered area percent, surgeon, and patient's subjective evaluation) and safety (as judged by adverse events). The overall scalp surface restored with artificial hair (mm2 spaced) and pre-postoperative general customers' satisfaction (by Hamilton scale grading) are reported, showing a significant (98,14%) subjective and objective improvement of the self-image. Twenty-two cases (8.75%) declared minor side effects generally counteracted by topical or short course systemic antibiotic and anti-inflammatory treatment. The average number of implanted fibers was 2,295 (SD 2.805; SE 200.9) ranging from 300 to 16,000. The average duration of pain and tenderness at the implant area was 2.2 days (SD 4.096; SE 0.2933) ranging from 1 to 20 days. A diagrammatic comparison of the Hamilton scale grading before and after the trial showed a dramatic improvement with the majority of the patients being in Hamilton grade II after implantation.

Biofibre® artificial hair implant: Retrospective study on 1,518 patients with alopecia and present role in hair surgery.

To treat alopecia, there are many surgical and nonsurgical treatments available nowadays. In the surgical one, the Biofibre® hair implantation system represents an important innovation with artificial hair with special physical, chemical, and mechanical features and the new Biofibre® Automatic device. Implant on 1,518 patients has been reported in this study where the Biofibre® hair implant technique is performed on men and women with varying degrees of baldness and for the treatment of various causes of alopecia such as androgenetic alopecia, burns, and scars. According to our experience, this technique gives immediate and visible results without scarring or hospitalization and the aesthetic results are very encouraging for both male and female patients with a rapid recovery of self-esteem and psychological well-being.

Automatic Artificial Hair Implant: Safety and Efficacy in Androgenetic Alopecia. A Prospective Study with a Highly Biocompatible Fiber.

AIM: A multi - centre two years the long prospective open clinical study was conducted in five countries located in four different continents from May 2015 to evaluate the clinical safety and efficacy of Automatic Biofibre hair implant in male and female androgenetic alopecia. Biofibre®is a CE/TGA certified medical grade polyamide fibre suitable for implantation. MATERIAL AND METHODS: A total of 213 patients were enrolled in the study. Patients were assessed pre -operatively by Hamilton scale grading and the percentage of scalp covered by hair. All the patients underwent Biofibre hair implantation by a standardised surgical technique followed by adequate post-operative care. Efficacy of the implant was evaluated by surgeons and patients bimonthly for the first year and trimonthly during the second year. Any adverse effects were recorded during these visits. RESULTS: At the completion of the study period, a total of 194 patients concluded the trial and the results were statistically evaluated. Both Hamilton scale grading and covered area percent improved at the end of the study, and subjective and objective evaluations revealed satisfactory results. Side effects were reported in only 18 cases (9.27%) which were easily controlled by either topical or systemic treatment in 8 to 10 days. CONCLUSION: Overall a successful result was noticed in 97.94% of patients with great psychological satisfaction.

Artificial Hair: By the Dawn to Automatic Biofibre® Hair Implant.

Since the beginning of the twentieth century, there have been attempts at creating artificial hair to treat baldness. Major evolution took place at the end of 1970's when, unfortunately, artificial hair treatments were applied without appropriate medical controls, resulting in sub-standard results from the use of unsuitable materials and technique. The large improper use of this technique in North America from no medical personnel and with dangerous fibres led the Food and Drug Administration (FDA) to suspend the procedure in 1983. In Europe, a new trial on artificial hair procedure started at the beginning of 1990's. In 1995 the European Union (UE) recognised the artificial hair implant as a legitimate medical treatment and outlined the rules related to that procedure. In 1996, biocompatible fibres (Biofibre®) produced by Medicap® Italy were approved by the UE Authorities and by the Australian Therapeutic Goods Administration (TGA) as medical devices for hair implant. An effective medical protocol was developed during the following years to provide correct guidelines for appropriate treatment, and to reduce possible related complications. Automatic Biofibre® hair implant represents the last achievement in this hair restoration technique with significant advantages for the patients.

Alopecia por tração causada por utilização de implante capilar artificial em cabelos relaxados / Traction alopecia caused by the use of artificial hair implant in relaxed hair

A alopecia por tração é uma disfunção observada no couro cabeludo e causada por uma agressão mecânica externa, como por exemplo, a constante tração dos fios. O implante capilar artificial pode ser relacionado então como possível causa da alopecia por tração, pois, as usuárias não respeitam os prazos de manutenção, implantam quantidades de cabelo em excesso e associam ainda o relaxamento capilar. Tudo isso pode danificar a estrutura do fio de cabelo e o couro cabeludo. O objetivo deste estudo foi analisar se o uso de implante capilar artificial, associado ao relaxamento do fio, que pode causar a alopecia por tração. Foi realizado estudo comparativo com 30 mulheres, todas com as mesmas características capilares, adeptas do relaxamento capilar à base de hidróxido alcalino e uso de implante capilar artificial do tipo nó italiano. Para determinar a existência da alopecia por tração foi feita análise do couro cabeludo, por imagem, empregando o scanner modelo Babyvision. As imagens geradas foram avaliadas e interpretadas na tentativa de estabelecer correlação entre relaxamento capilar, implante capilar e alopecia de tração. Conclui-se que devido à tração realizada pelo implante artificial capilar houve comprometimento do couro cabeludo ocasionando a calvície permanente naquele local, denominada alopecia por tração. (AU)

Traction alopecia is a dysfunction observed in the scalp and caused by an external mechanical aggression, such as the constant pulling of the hair. The artificial capillary implant can be related as a possible cause of traction alopecia, since users do not observe maintenance periods, implant excessive amounts of hair and also associate capillary relaxation. All of this can damage the structure of the hair strand and the scalp. The objective of this study was to analyze whether the use of artificial capillary implants, associated with the relaxation of the thread can cause traction alopecia. A comparative study was performed with 30 women, all with the same capillary characteristics, adherents of capillary relaxation based on alkaline hydroxide and use of artificial capillary implant Italian knot type. To determine the existence of traction alopecia, scalp analysis was performed using the Babyvision scanner. The images were evaluated and interpreted in an attempt to establish a correlation between capillary relaxation, capillary implant and traction alopecia. It was concluded that, due to the traction performed by the artificial capillary implant, the scalp was compromised, causing permanent baldness at the site, called traction alopecia. (AU)