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

Abstract

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.

Side effects after artificial hair implants: 2 case reports

“…Studies have shown approximately 95% to 98% satisfaction rate among patients. 1 , 2 , 4 , 5 However, 6% to 13% reported allergic, inflammatory, or infectious complications in which approximately 2% were not solved and required fiber extraction. 1 , 2 , 3 , 4 Infections are mainly caused by Staphylococci aureus and epidermidis , Streptococcus pyogenes, and corynebacterium.…”

“… 1 , 2 , 4 , 5 However, 6% to 13% reported allergic, inflammatory, or infectious complications in which approximately 2% were not solved and required fiber extraction. 1 , 2 , 3 , 4 Infections are mainly caused by Staphylococci aureus and epidermidis , Streptococcus pyogenes, and corynebacterium. 1 , 5 Inflammatory complications are described as mild reddening and itching, 6 histologically shown as peri-implant inflammation and folliculitis 7 and in some cases foreign body reactions.…”

“… 1 , 2 , 3 , 4 Infections are mainly caused by Staphylococci aureus and epidermidis , Streptococcus pyogenes, and corynebacterium. 1 , 5 Inflammatory complications are described as mild reddening and itching, 6 histologically shown as peri-implant inflammation and folliculitis 7 and in some cases foreign body reactions. 8 During the initial tolerance test, some patients had a hypersensitivity reaction.…”

“…Therefore, the Council concerning Medical Devices in the European Union recognized the artificial hair implant technique as a medical act in 1996. 1 , 2 …”

“…Biocompatible fiber is a polyamide fiber, which is 0.08 to 0.09 mm thick and 160 to 460 mm long. 1 The implant technique is a surgery technique, performed by either a manual implanter or an automatic machine, under local anesthesia. A small hooking needle places the root of the fiber under the scalp at galea level ( Fig 1 ) where the root can be held by fibrous tissue.…”