Polyamide hair implant (biofibre®): evaluation of efficacy and safety in a group of 133 patients

J Biol Regul Homeost Agents. 2015 Jan-Mar;29(1 Suppl):103-9.

Abstract

One of the greatest challenges in medicine is treatment of both feminine and masculine baldness. Among several surgical treatments available, artificial hair implantation has to be listed. We report the efficacy and safety of hair fibre implants, (Biofibre®), through the follow-up of 133 patients in three years. One-hundred-and-thirty-three patients, 98 male and 38 female, with alopecia or baldness, were treated with the hair implant (Biofibre®) which is made from a mixture of polyamides. The patients included had good state of health, healthy scalp and they were diligent in scalp cleaning. Patients with atopic dermatitis, lupus, seborrhoeic dermatitis and other skin diseases were excluded. Patients' scalps had to be normalized in case of local diseases. A clinical evaluation was carried out after 1 month, 4 months, and every other 4 months after the implant. Efficacy and safety of the product were evaluated in each patient. The most represented group consisted of men aged between 30 and 60, belonging to a scale of Hamilton III to IV. They underwent implants of up to 6000 fibres (average of 5-6 implants in three months). The fibre loss was of no more than 10% per year in 91.4% of the cases, 15% in 7.8% of the cases and 20% in 0.8% of the cases. 96.2% of patients declared to be satisfied from the result of the implant while 3.8% declared to not be satisfied. As for post-implantation tolerability and complications, 90.3% of patients recorded no pathology after surgery/ies. The 5.9% presented mild infection pathologies and the 3.8% presented inflammation pathologies (mainly from the use of wrong chemical substances). The resolution of the septic and chemical pathologies occurred in 97.9% of the cases within an average of 15 days with the use of systemic antibiotic and/or steroid local therapy. In 2.1% of the cases it was necessary to remove the fibres which took place without leaving any lasting scar. The implant of polyamide hairs (Biofibre®) can be considered an efficient surgical technique that allows immediate aesthetic results. In our study, hair implant technique demonstrated to be safe and well tolerated by patients.