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.

Modern artificial hair implantation: a pilot study of 10 patients.

BACKGROUND: Androgenetic alopecia is an intriguing problem with significant psychological sequelae. Follicular unit transplantation is unsatisfactory in donor depleted cases and artificial hair implantation has historically been marred by poor quality fiber, untrained operators, and inadequate techniques. OBJECTIVE: This paper aims to establish safety and efficacy of a new artificial copolyamide fiber implantation in androgenetic alopecia. METHODS: Ten healthy adults with androgenetic alopecia who had failed prior conventional therapies were implanted with copolyamide fiber and were followed for a minimum of 3 years. Implantation consisted of 100 test fibers followed by subsequent sessions of up to 500 fibers every 4-6 weeks to achieve a density of 20-40 fibers per cm(2). Implantation techniques and follow-ups maintained a strict adherence to schedule. RESULTS: A total of 10,000 fibers were implanted with a mean of 1000 fibers per patient. With the exception of one patient, implantation was found to be safe, aesthetically pleasing, and psychologically rewarding to its recipients. Sebum deposition and temporary pitting at entry point of most fibers were universal. Recurrent mild folliculitis occurred in 30% of patients. Facial swelling, cellulitis, and severe scarring were absent. Annual fiber fall rate was 15-20%. CONCLUSION: Choice of fiber, implantation technique, and mandatory follow-up were deemed to be some of the important contributory factors towards our positive results.