Artificial hair transplantation is a medical procedure in which specially designed artificial fibers are inserted into the scalp to aesthetically improve hair density. Unlike hair transplantation, the patient's own hair follicles are not transferred from a donor area. Suitability for the procedure must be assessed by a qualified physician.

No. The Biofibre® implant and hair transplant are different procedures. In hair transplants, the patient's natural hair follicles are transferred from a donor area to a thinning area. In the Biofibre® implant, biocompatible artificial fibers are inserted. The scientific literature considers artificial hair implantation and hair transplantation to be distinct approaches to hair restoration.

Biofibre® 4.0 is the implantable device used for the procedure. Medicap® High Density 4.0 is the high-density variant: Medicap documentation describes High Density as designed to obtain three artificial hairs from a single implanted root. Medicap® 4.0 Hair Implant System refers to the overall implant system. Distinguishing between fiber/device, high-density variant, and system avoids confusion between product and procedure.

No. Le fibre artificiali non sono follicoli biologici e quindi non crescono come i capelli naturali. La loro lunghezza rimane quella scelta per l'impianto. Questa è una delle differenze fondamentali rispetto all'autotrapianto, nel quale i follicoli trapiantati possono produrre capelli biologici.

L'impianto di fibre artificiali produce un aumento estetico della densità visibile senza dover attendere la crescita biologica di nuovi capelli. Gli studi pubblicati sull'artificial hair implantation descrivono proprio il risultato estetico immediato fra le caratteristiche della procedura. Il risultato finale dipende comunque dal numero di fibre, dalla zona trattata, dalle caratteristiche del paziente e dal programma stabilito dal medico.

La procedura viene eseguita in anestesia locale. Nelle ore successive può comparire un moderato disagio o gonfiore del cuoio capelluto come conseguenza della procedura e dell'anestesia. Se il dolore o altri sintomi persistono o peggiorano, è opportuno contattare il medico che ha eseguito l'impianto. Nella quasi totalità dei casi è possibile riprendere le attività quotidiane dopo l’impianto.

L'impianto è una procedura medica ambulatoriale eseguita in anestesia locale da un medico formato. Le fibre vengono inserite nel cuoio capelluto una alla volta con l'implanter previsto dal sistema, manuale o automatico, secondo il piano di trattamento e fino alla densità programmata. Modalità operative, numero di fibre e sequenza delle sedute devono essere definiti dal medico e allineati alle istruzioni d'uso e al protocollo Medicap vigenti.

La durata di una seduta dipende dal numero di fibre da impiantare, dall'area da trattare, dalla densità desiderata e dal piano definito dal medico. Il protocollo d’impianto di Medicap indica orientativamente una durata da una a poche ore, ma l'intervallo preciso deve essere confermato dal consulente medico e allineato alla procedura ufficiale prima della pubblicazione.

The number of fibers implanted in a single session varies based on the treatment area, the desired density, the scalp condition, and the doctor's plan. The currently published Medicap® FAQ recommends a guideline of 800-1,500 fibers per session. Medicap® High Density 4.0, on the other hand, is designed to obtain three artificial hairs with a single implanted root. These values ​​should not be interpreted as a standard for every patient.

The frequency of sessions must be determined by the physician based on the area being treated, the scalp's response, and the overall implant program. The currently published Medicap® FAQ indicates, as a guideline, the possibility of repeating the implant on different areas after approximately five weeks and specifies that it should be performed exclusively on healthy skin. This interval should not be automatically applied to all patients.

Artificial fibers are available in different aesthetic characteristics to allow the physician to select the solution best suited to the patient's natural hair and goals. The choice must be made during treatment planning, considering color, density, length, and characteristics of the area to be treated.

Yes, they can be shortened, but they don't grow back because they're not organic hair. For this reason, any significant changes in length or style should be carefully evaluated and, if necessary, discussed with the patient's doctor and/or stylist.

The implant can be evaluated in selected patients with hair loss or thinning who wish to increase aesthetic density and who are deemed suitable after a medical evaluation. Candidacy depends on the patient's general health, scalp condition, type of alopecia, expectations, and the device's indications and contraindications.

Sì. Biofibre® 4.0 e Medicap® High Density 4.0 non sono destinati a tutti i pazienti. Il protocollo d’impianto Medicap prevede specifiche limitazioni e richiede buone condizioni generali, un cuoio capelluto sano e una valutazione clinica prima dell'impianto. L'SSCP indica inoltre che il dispositivo non è indicato in caso di alopecia reversibile; l'elenco completo delle controindicazioni deve essere verificato nelle istruzioni d'uso vigenti.

No. La documentazione Medicap specifica che Biofibre® 4.0 e Medicap® High Density 4.0 sono destinati a pazienti adulti selezionati e non sono indicati per tutte le forme di alopecia. L'SSCP esclude l'alopecia reversibile e, nelle avvertenze generali, richiama anche l'alopecia autoimmune. Per questo la diagnosi e l'idoneità devono essere stabilite dal medico prima del trattamento.

L'alopecia totale richiede una valutazione medica particolarmente prudente e non costituisce un'indicazione automatica all'impianto. La documentazione Medicap specifica che Biofibre® 4.0 e Medicap® High Density 4.0 non sono indicati per tutte le forme di alopecia e richiama anche l'alopecia autoimmune nelle avvertenze generali. Eventuali casi trattati e documentati devono quindi essere interpretati individualmente e non come prova che la procedura sia adatta a ogni paziente con alopecia totale.

No. L'uso previsto riguarda aree diradate o calve del cuoio capelluto. La documentazione Medicap specifica che Biofibre® 4.0 e Medicap® High Density 4.0 non sono indicati per l'infoltimento di sopracciglia, baffi, barba, torace o pube.

Può essere una delle situazioni nelle quali l'artificial hair implantation viene valutata. Una review scientifica identifica infatti questa procedura come possibile alternativa nei pazienti con zona donatrice esaurita o non adeguata al trapianto. Questo non significa però che sia automaticamente indicata: occorre una valutazione individuale da parte del medico.

Quando il paziente dispone di una zona donatrice sufficiente e sana, l'autotrapianto FUE/FUT consente di utilizzare follicoli propri, con capelli che possono crescere biologicamente nel tempo. L'impianto di capelli artificiali può invece essere valutato quando la zona donatrice non è sufficiente, quando si ricerca un incremento estetico immediato della densità o in specifiche strategie combinate. La scelta non è automatica: tipo di alopecia, area donatrice, condizioni del cuoio capelluto, rischi, manutenzione, obiettivi estetici, aspettative e preferenze del paziente devono essere valutati insieme al medico.

In alcuni pazienti può essere valutata una strategia combinata o successiva ad altri trattamenti di hair restoration. La possibilità dipende però dalla situazione clinica, dalla qualità del cuoio capelluto, dai trattamenti precedenti e dagli obiettivi estetici. Non è quindi una scelta automatica e deve essere pianificata dal medico.

L'eventuale associazione tra impianto e terapie per la caduta dei capelli deve essere valutata dal medico caso per caso. Il professionista deve conoscere i trattamenti in corso prima della procedura, perché alcuni farmaci o terapie possono influire sulle condizioni del cuoio capelluto, sulla guarigione o sulla tollerabilità. La decisione di proseguire, modificare o sospendere una terapia non deve essere presa autonomamente dal paziente, ma concordata con il medico curante e con il medico che esegue l'impianto.

Esiste letteratura sull'impiego di fibre artificiali in pazienti selezionati con cicatrici del cuoio capelluto. Uno studio ha analizzato 54 cicatrici in 44 pazienti trattati con fibre Biofibre®, riportando risultati e complicanze della procedura. L'idoneità di una cicatrice all'impianto deve comunque essere valutata individualmente dal medico.

In selected patients, a gradual transition from hair replacement to implant may be considered after assessing the scalp condition. The planning must be defined by the physician, and the newly treated areas must be managed according to post-implantation guidelines. The timing and method of hair replacement, as well as the possible use of coverings over the implanted area, must be agreed upon with the clinic to avoid interfering with hygiene, healing, and scalp monitoring.

Yes. Before the implant, the patient must be evaluated by a doctor, who will verify the patient's general health, scalp condition, the cause of hair loss, and the absence of conditions that would make the treatment unsuitable. Any tests deemed necessary by the doctor may also be performed. Proper patient selection is an integral part of the procedure's safety.

Medicap documentation requires that the device be used by physicians certified by Medicap® for implantation or by authorized tutor physicians. Before the procedure, it is therefore advisable to verify the practitioner's qualifications and specific training on the system being used.

The cost varies based on the number of hairs to be implanted, the desired density, the area to be treated, and the physician performing the procedure. Medicap® provides devices to professionals and does not set a single price for the treatment to the patient: the estimate is determined by the doctor or facility after a clinical evaluation and treatment plan. For an exact cost, it is therefore necessary to request a consultation or a quote from your healthcare provider.

No. Like any medical implant procedure, artificial hair implants also carry residual risks. Medicap documentation specifically highlights potential infections and inflammation of the scalp and emphasizes the importance of diagnosis, patient selection, proper procedure, hygiene, and follow-up.

The main residual risks described in the Medicap documentation are infectious and inflammatory conditions of the scalp. If recognized and treated correctly, they can generally be managed and resolve quickly; however, if not treated promptly and appropriately, they can lead to more serious complications.

If a persistent reaction, inflammation, or infection occurs, the patient should be evaluated by a physician. With appropriate therapy, these symptoms generally resolve within about ten days without sequelae. If not treated promptly, however, they can develop into more serious complications (such as pyoderma or granulomatous nodules), eventually requiring removal of the affected fibers. This information is reported in the device's official technical documentation (SSCP).

Yes, fibers can be removed when clinically necessary. Medicap documentation describes removal as a possible measure when a reaction doesn't respond to treatment. Any extraction must be performed and managed by a physician; the patient should not attempt to remove the fibers themselves.

The Medicap technical documentation identifies Biofibre® 4.0 and Medicap® High Density 4.0 as biocompatible implantable artificial hair and reports biocompatibility tests performed according to applicable standards, including several tests from the ISO 10993 series. This does not mean absolute absence of risk: individual compatibility and correct patient selection remain essential.

Transient redness may appear after the implant. The Patient Protocol recommends following the clinic's instructions and contacting your doctor if redness, pain, itching, swelling, or other symptoms persist or worsen. Management should be personalized by your doctor, without turning this FAQ into a therapeutic prescription.

If infectious or inflammatory symptoms appear that do not respond adequately to the treatment prescribed by the doctor, Medicap documentation indicates that removal of the responsible fibers may be necessary. The patient should therefore contact their doctor and not attempt to manage a persistent reaction on their own.

Yes. Evaluating tolerability is part of the precautionary approach to the procedure. Medicap's medical protocol requires verifying the patient's compatibility with the device before proceeding with the full implant. The clinical evidence summarized in the SSCP also describes a trial implant with a limited number of fibers. The FAQ should therefore discuss compatibility testing or verification, referring to the current instructions for use for details on how and when to perform the procedure.

The risk of infection exists. To reduce it, proper patient selection, the procedure performed by a trained physician, scalp hygiene, and compliance with the post-implantation protocol are important. If you experience increasing pain, heat, discharge, or other suspicious symptoms, it is important to contact your doctor. The literature on artificial hair implantation aftercare emphasizes the importance of regular checkups and scalp care in preventing and early identifying potential complications. Patients must follow their doctor's instructions and the post-treatment protocol.

Published studies report adverse events in a minority of patients, with results varying depending on the study and the population studied. In one prospective study, 18 of 194 patients who completed follow-up experienced adverse events; in a three-year multicenter study, 22 cases of minor adverse events were reported among 253 patients who completed the study. The data should be read in the context of each study's design and limitations. A 2019 review, which analyzed multiple published studies on Biofibre® conducted between 1994 and 2018, also reported a rate of adverse events that decreased over time from 20.8% to 9.27%—a trend consistent with the evolution of materials and protocols described in Research and Development. The data should be read in the context of each study's design and limitations.

It's a good idea to contact your doctor if you experience persistent itching, redness, or pain, or other concerning symptoms. The Patient Protocol recommends personalized checkups and a medical evaluation if symptoms don't resolve as expected. Medical follow-up is essential to monitor the scalp's condition and intervene promptly when necessary.

The result requires long-term maintenance. Artificial fibers do not grow back, and some may be gradually lost. The SSCP summarizes clinical data that recommends annual maintenance for patients, but individual results also depend on the scalp's condition, hygiene, follow-up, and adherence to the post-implantation protocol. Durability depends on numerous factors, including individual characteristics, treated area, scalp care, follow-up, and adherence to post-implantation guidelines.

Some fiber loss over time has been observed in clinical studies. In a three-year follow-up study of 133 patients, 91.4% of cases had a loss of no more than 10% per year; higher percentages were observed in smaller groups. This data is specific to that specific study and should not be interpreted as a guaranteed percentage for every patient.

Since some fibers naturally lose weight over time, the patient, in consultation with their doctor, can choose to undergo maintenance sessions to maintain the desired density. Frequency and quantity depend on the individual situation and cannot be established with a uniform rule for everyone.

If some fibers are lost over time and not replaced, the density achieved with the implant may gradually decrease. The procedure does not alter the fact that the fibers are artificial and cannot regenerate biologically.

The number depends on the size of the area, the initial density, the fiber characteristics, and the aesthetic goal. In published studies, the number of fibers varies widely among patients, confirming that there is no standard number that works for everyone. The plan must be defined by the doctor after an individual evaluation.

No. Density, final aesthetics, tolerability, and maintenance can vary between patients. Clinical studies also use individual assessments of outcome and satisfaction. A 2025 case series on Biofibre® 4.0, for example, separately assessed satisfaction and fiber loss at one year.

Yes. The Results section of the Medicap website contains before/after case studies.

Yes. Good scalp hygiene and proper post-implant maintenance are key elements in managing Biofibre®. The Patient Protocol provides specific instructions for cleansing, sebum, sweat, products used, and periodic check-ups.

In the first few hours and days, it's necessary to follow a specific hygiene protocol. The Patient Protocol recommends not shampooing or combing the implanted area on the first day and gradually introduces washing instructions in the following days. For exact times and products, it's best to refer to the protocol and clinic instructions.

Implant stabilization occurs gradually in the weeks following the procedure. The currently published Medicap® FAQ indicates a period of approximately 20-30 days for fixation, during which it is important to avoid excessive traction and carefully follow the post-implantation instructions. The actual time may depend on the procedure performed and the individual response, so the patient must adhere to the clinic's instructions and scheduled check-ups.

The implant is an outpatient procedure that requires no recovery time or dressings, and most patients resume their daily activities shortly after the session. However, the time it takes to return to work, hairdressing, and normal activities depends on the procedure performed and the post-implant indications. Patients must follow their doctor's instructions in the hours and weeks following the procedure, especially regarding hygiene, physical activity, and protection of the treated area.

Yes, but some restrictions apply during the first few weeks. The Patient Protocol recommends avoiding or reducing physical exertion and associated sweating during the first month to promote healing. Recovery must still follow your doctor's instructions based on the extent of the implant and your individual response.

Yes, but precautions are required during the initial period. The Patient Protocol recommends avoiding or reducing sea, pool, and sauna bathing during the first month; subsequently, it provides specific hygiene and protection recommendations.

Not all products are suitable. The Patient Protocol recommends gentle cleansing and avoids harsh or non-clinically prescribed products, as they can irritate the scalp or damage the hair fibers. For a complete list of recommended and avoidable products, please refer to the Aftercare document. It is advisable to follow your doctor's instructions and use products compatible with the recommended maintenance program.

Yes, but with limitations. The Patient Protocol recommends avoiding dyes containing ammonia or resorcinol and advises against aggressive treatments such as perms, permanent straightening, and bleaching. For specific products and treatments, please consult the protocol and ask the clinic for recommendations.

It's advisable to avoid harsh heat treatments. The Patient Protocol advises against using straighteners and curling irons and recommends avoiding excessive heat, which can alter or damage the appearance of the hair fibers. For drying and styling, it's best to follow the protocol and clinic instructions.

Yes. Follow-up allows us to monitor the scalp, identify any problems, and develop a personalized maintenance program. The Patient Protocol recommends check-ups according to the schedule established with the clinic and an evaluation in case of itching, redness, or persistent pain.

Yes. The SSCP Medicap collects and summarizes clinical data from studies and publications on Biofibre®, Medicap® High Density, and devices deemed equivalent or similar, as well as biocompatibility data for 4.0 devices.

The Medicap documentation reports a clinical and regulatory history that dates back to the 1990s and cites the first CE certification of Biofibre® in 1996. The SSCP also collects studies with very diverse case histories, from small clinical trials to publications summarizing over a thousand patients.

The Medicap documentation summarizes clinical data reporting favorable aesthetic and patient satisfaction outcomes, along with adverse events and residual risks that must be managed with appropriate selection, follow-up, and maintenance. The SSCP also distinguishes data from the 4.0 device from historical data and from equivalent or similar devices. Therefore, the evidence must be considered as a whole, without interpreting a single study as definitive proof of safety or efficacy for every patient.

Yes. In the United States, federal regulations continue to classify "prosthetic hair fibers" intended for implantation in the scalp as prohibited devices. This framework stems from the 1983 FDA regulation and must be read in the historical context of the fibers, materials, and techniques used at the time.

The US measure dates back to 1983 and is linked to the history of artificial fiber implantation techniques developed in the previous decades. Literature from the 1970s and 1980s described significant complications associated with some fibers and techniques of the time, including infections, foreign body reactions, scarring, and difficult removal. The issue must therefore be placed in its correct historical and regulatory context.

The US regulation is not formulated as a specific provision referring to the Biofibre® 4.0 brand: it regulates the category of prosthetic hair fibers intended for scalp implantation. To avoid misinterpretation, the regulatory status of Biofibre® must be described separately for each market based on updated regulatory documentation.

It is incorrect to consider all generations of artificial fibers as technologically identical. Subsequent literature describes the development of materials, techniques, systems, and medical implant protocols that differ from some of the technologies historically associated with complications in the 1970s and 1980s. This does not eliminate the need to evaluate the risks and benefits of modern technologies based on contemporary clinical evidence.

Regulatory status may vary by market and must be verified using current documentation. In the European Union, Biofibre® 4.0 and Medicap® High Density 4.0 are identified as Class IIb devices with a CE MDR certificate issued by the notified body 0373 - Istituto Superiore di Sanità.

Medicap® collects the publications available in the Literature and Clinical Studies sections of the site.

No. No clinical study can prove that a procedure is appropriate for every patient with hair loss. Published studies use specific selection criteria and populations and report both outcomes and adverse events. The literature should support clinical decisions, not replace individual physician assessment.