An artificial hair implant is a medical procedure in which artificial fibres designed for implantation are inserted into the scalp to aesthetically improve hair density. Unlike hair transplantation, no follicles are moved from a donor area of the patient. Suitability for the procedure must be assessed by a qualified physician.

No. The Biofibre® implant and hair transplantation are different procedures. In hair transplantation, the patient's own natural follicles are moved from a donor area to a thinning area. With the Biofibre® implant, biocompatible artificial fibres are inserted instead. The scientific literature treats artificial hair implantation and hair transplantation as 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 implant system as a whole. Distinguishing between fibre/device, high-density variant and system avoids confusion between product and procedure.

No. Artificial fibres are not biological follicles, so they do not grow like natural hair. Their length remains the length chosen for the implant. This is one of the fundamental differences from hair transplantation, in which the transplanted follicles can produce biological hair.

Implanting artificial fibres produces an aesthetic increase in visible density without having to wait for new hair to grow biologically. Published studies on artificial hair implantation specifically list the immediate aesthetic result among the characteristics of the procedure. The final result nevertheless depends on the number of fibres, the area treated, the patient's characteristics and the plan set by the physician.

The procedure is performed under local anaesthesia. In the following hours, moderate discomfort or swelling of the scalp may occur as a result of the procedure and the anaesthetic. If pain or other symptoms persist or worsen, the patient should contact the physician who performed the implant. In almost all cases, daily activities can be resumed after the implant.

The implant is an outpatient medical procedure performed under local anaesthesia by a trained physician. The fibres are inserted into the scalp one at a time using the implanter provided with the system, manual or automatic, according to the treatment plan and up to the planned density. The operating method, number of fibres and sequence of sessions must be defined by the physician and comply with the current instructions for use and Medicap protocol.

The length of a session depends on the number of fibres to be implanted, the area to be treated, the desired density and the plan defined by the physician. Medicap's implant protocol gives an indicative duration of one to a few hours, but the exact range must be confirmed by the medical consultant and aligned with the official procedure before publication.

The number of fibres implanted in a single session varies according to the area to be treated, the desired density, the condition of the scalp and the plan defined by the physician. The Medicap® FAQ currently published gives an indicative figure of 800–1,500 fibres per session. Medicap® High Density 4.0, by contrast, is designed to obtain three artificial hairs from a single implanted root. These figures should not be interpreted as a standard applicable to every patient.

The frequency of sessions must be set by the physician based on the area treated, the response of the scalp and the overall implant programme. As an indicative reference, the Medicap® FAQ currently published mentions the possibility of repeating the implant on different areas after about five weeks, and specifies that treatment must only be carried out on healthy skin. This interval should not be applied automatically to all patients.

Artificial fibres are available with different aesthetic characteristics so that the physician can select the solution best suited to the patient's natural hair and goals. The choice should be made during treatment planning, taking into account the colour, density, length and characteristics of the area to be treated.

Yes, it can be shortened, but it does not grow back because it is not biological hair. For this reason, any significant change in length or style should be carefully considered and, where necessary, discussed with the physician and/or the patient's hairdresser.

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

Yes. Biofibre® 4.0 and Medicap® High Density 4.0 are not intended for all patients. Medicap's implant protocol sets out specific limitations and requires good general health, a healthy scalp and a clinical assessment before the implant. The SSCP also states that the device is not indicated for reversible alopecia; the full list of contraindications must be checked in the current instructions for use.

No. Medicap documentation specifies that Biofibre® 4.0 and Medicap® High Density 4.0 are intended for selected adult patients and are not indicated for all forms of alopecia. The SSCP excludes reversible alopecia and its general warnings also mention autoimmune alopecia. For this reason, the diagnosis and suitability must be established by the physician before treatment.

Alopecia totalis requires a particularly cautious medical assessment and is not an automatic indication for the implant. Medicap documentation specifies that Biofibre® 4.0 and Medicap® High Density 4.0 are not indicated for all forms of alopecia and its general warnings also mention autoimmune alopecia. Any treated and documented cases must therefore be interpreted individually, not as proof that the procedure is suitable for every patient with alopecia totalis.

No. The intended use concerns thinning or bald areas of the scalp. Medicap documentation specifies that Biofibre® 4.0 and Medicap® High Density 4.0 are not indicated for thickening the eyebrows, moustache, beard, chest or pubic area.

This can be one of the situations in which artificial hair implantation is considered. A scientific review identifies the procedure as a possible alternative for patients whose donor area is depleted or unsuitable for transplantation. However, this does not mean it is automatically indicated: an individual assessment by the physician is required.

When the patient has a sufficient and healthy donor area, FUE/FUT hair transplantation makes it possible to use the patient's own follicles, with hair that can grow biologically over time. An artificial hair implant may instead be considered when the donor area is insufficient, when an immediate aesthetic increase in density is sought, or as part of specific combined strategies. The choice is not automatic: the type of alopecia, donor area, scalp condition, risks, maintenance, aesthetic goals, expectations and patient preferences must all be assessed together with the physician.

In some patients, a strategy combined with, or following, other hair restoration treatments may be considered. However, this depends on the clinical situation, the quality of the scalp, previous treatments and aesthetic goals. It is therefore not an automatic choice and must be planned by the physician.

Any combination of the implant with hair loss treatments must be assessed by the physician on a case-by-case basis. The physician must be aware of any ongoing treatments before the procedure, as some medicines or therapies can affect the condition of the scalp, healing or tolerability. The decision to continue, change or stop a treatment should not be made by the patient alone, but agreed with their own doctor and with the physician performing the implant.

There is literature on the use of artificial fibres in selected patients with scalp scars. One study analysed 54 scars in 44 patients treated with Biofibre® fibres, reporting the results and complications of the procedure. The suitability of a scar for implantation must nevertheless be assessed individually by the physician.

In selected patients, a gradual transition from a hair system to the implant can be considered after checking the condition of the scalp. The plan must be defined by the physician, and freshly treated areas must be managed according to the post-implant instructions. The timing and method for reducing use of the hair system, as well as any use of coverings over the implanted area, must be agreed with the clinic so as not to interfere with hygiene, healing and monitoring of the scalp.

Yes. Before the implant, the patient must be assessed by the physician, who checks their general health, the condition of the scalp, the cause of hair loss and the absence of conditions that could make the treatment unsuitable. Any tests the physician considers necessary may also be carried out. Correct patient selection is an integral part of the safety of the procedure.

Medicap documentation requires the device to be used by physicians qualified for implantation by Medicap® or by authorised tutor physicians. Before the procedure, it is therefore advisable to check the physician's qualifications and specific training in the system used.

The cost varies according to the number of hairs to be implanted, the desired density, the area to be treated and the physician performing the procedure. Medicap® supplies devices to professionals and does not set a single treatment price for patients: the quote is set by the physician or clinic after the clinical assessment and treatment plan. For an exact cost, you need to request a consultation or quote from the relevant professional.

No. Like any medical implant procedure, artificial hair implantation carries residual risks. Medicap documentation highlights in particular possible infectious and inflammatory reactions of the scalp, and stresses the importance of diagnosis, patient selection, correct procedure, hygiene and follow-up.

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

In the event of a persistent reaction, inflammation or infection, the patient must be assessed by the physician. With appropriate treatment, these reactions generally resolve within about ten days without lasting effects; if not treated promptly, they can develop into more serious complications (such as pyoderma or granulomatous nodules), to the point of requiring removal of the affected fibres. These data are reported in the device's official technical documentation (SSCP).

Yes, the fibres can be removed when clinically necessary. Medicap documentation describes removal as a possible measure when a reaction does not respond to treatment. Any removal must be performed and managed by the physician; patients must not attempt to remove the fibres themselves.

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

Temporary redness may appear after the implant. The Patient Protocol advises following the clinic's instructions and contacting the physician if redness, pain, itching, swelling or other symptoms persist or worsen. Management must be tailored by the physician, without turning the FAQ into a treatment prescription.

If infectious or inflammatory reactions occur that do not respond adequately to the treatment prescribed by the physician, Medicap documentation states that removal of the fibres responsible may become necessary. The patient should therefore contact the physician and not attempt to manage a persistent reaction on their own.

Yes. Assessing tolerability is part of the cautious approach to the procedure. Medicap's medical protocol requires the patient's compatibility with the device to be checked before proceeding with the full implant. The clinical evidence summarised in the SSCP also describes a test implant with a limited number of fibres. The FAQ should therefore refer to a compatibility test or check, referring to the current instructions for use for method and timing.

There is a risk of infection. To reduce it, correct patient selection, a procedure performed by a trained physician, scalp hygiene and adherence to the post-implant protocol are important. In the event of increasing pain, warmth, discharge or other suspicious symptoms, it is important to contact the physician. The literature on aftercare following artificial hair implantation stresses the importance of regular check-ups and scalp care in preventing and detecting possible complications early. The patient must follow the physician's instructions and the post-treatment protocol.

Published studies report adverse events in a minority of patients, with results varying according to the study and the population analysed. In one prospective study, 18 of the 194 patients who completed follow-up experienced side effects; in a three-year multicentre study, 22 cases of minor side effects were reported among 253 patients who completed the study. The data must be read in the context of each study's design and limitations. A 2019 review analysing several published studies on Biofibre® conducted between 1994 and 2018 also reports a side-effect rate that fell 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 must be read in the context of each study's design and limitations.

You should contact the physician if you experience persistent itching, redness or pain, or other symptoms that cause concern. The Patient Protocol recommends check-ups according to a personalised schedule and a medical assessment when symptoms do not resolve as expected. Medical follow-up serves precisely to monitor the condition of the scalp and to intervene promptly when needed.

The result requires maintenance over time. Artificial fibres do not grow back, and some may be gradually lost. The SSCP summarises clinical data indicating annual maintenance for patients, but the individual result also depends on the condition of the scalp, hygiene, follow-up and adherence to the post-implant protocol. Duration depends on numerous factors, including individual characteristics, the area treated, scalp care, follow-up and adherence to post-implant instructions.

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

Since some fibres are physiologically lost over time, the patient may decide together with the physician to have maintenance sessions to preserve the desired density. Frequency and quantity depend on the individual situation and cannot be set by a single rule for everyone.

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

The number depends on the size of the area, the initial density, the characteristics of the fibres and the aesthetic goal. In published studies, the number of fibres varies widely between patients, confirming that there is no standard quantity that applies to everyone. The plan must be defined by the physician after an individual assessment.

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

Yes. The Results section of the Medicap website contains before/after photographic cases.

Yes. Good scalp hygiene and correct post-implant maintenance are central to the management of Biofibre®. The Patient Protocol includes specific guidance on cleansing, sebum, sweat, products used and regular check-ups.

A specific hygiene protocol must be followed in the first hours and days. The Patient Protocol recommends not shampooing or combing the implanted area on the first day and gradually introduces washing instructions over the following days. For exact timing and products, it is best to refer to the protocol and the clinic's instructions.

The implant stabilises gradually over the weeks following the procedure. The Medicap® FAQ currently published gives an indicative period of about 20–30 days for anchoring, during which it is important to avoid excessive pulling and to follow the post-implant instructions carefully. The actual time may depend on the procedure performed and the individual response, so the patient should follow the clinic's instructions and attend scheduled check-ups.

The implant is an outpatient procedure that requires no convalescence or bandages, and most patients resume their daily activities shortly after the session. However, the timing for returning to work, styling hair and normal activities depends on the procedure performed and the post-implant instructions. The patient must follow the physician's instructions in the hours and weeks that follow, particularly regarding hygiene, physical activity and protection of the treated area.

Yes, but some restrictions apply in the first few weeks. The Patient Protocol recommends avoiding or reducing physical exertion and the resulting sweating during the first month to support healing. Returning to sport should in any case follow the physician's instructions, depending on the extent of the implant and the individual response.

Yes, but the initial period requires precautions. The Patient Protocol recommends avoiding or limiting swimming in the sea and in pools, as well as saunas, during the first month; it then provides specific hygiene and protection guidance.

Not all products are suitable. The Patient Protocol recommends gentle cleansing and advises against harsh products or products not prescribed by the clinic, as they can irritate the scalp or damage the fibres. For the full list of recommended products and products to avoid, it is best to refer to the After Care document. Patients should follow the physician's advice and use products compatible with the recommended maintenance programme

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

It is advisable to avoid harsh heat treatments. The Patient Protocol advises against straighteners and curling irons and recommends avoiding excessive heat, as it can alter or damage the appearance of the fibres. For drying and styling, it is best to follow the guidance in the protocol and from the clinic.

Yes. Follow-up makes it possible to monitor the scalp, identify any problems and define a personalised maintenance programme. The Patient Protocol recommends check-ups according to the schedule agreed with the clinic and an assessment in the event of persistent itching, redness or pain.

Yes. Medicap's SSCP collects and summarises clinical data from studies and publications on Biofibre®, Medicap® High Density and devices considered equivalent or similar, as well as biocompatibility data on the 4.0 devices.

Medicap documentation reports a clinical and regulatory history dating back to the 1990s and cites the first CE certification of Biofibre® in 1996. The SSCP also collects studies with very different sample sizes, ranging from small clinical studies to publications summarising more than a thousand patients.

Medicap documentation summarises clinical data reporting favourable aesthetic and satisfaction results, together with adverse events and residual risks that must be managed through correct selection, follow-up and maintenance. The SSCP also distinguishes data on the 4.0 device from historical data and data on equivalent or similar devices. The evidence must therefore be considered as a whole, without interpreting any single study as definitive proof of safety or effectiveness for every patient.

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

The US measure dates back to 1983 and is linked to the history of artificial fibre implant techniques developed in previous decades. Literature from the 1970s and 1980s described serious complications associated with some fibres and techniques of the time, including infections, foreign-body reactions, scarring and difficulty in removal. The topic must therefore be placed in its proper historical and regulatory context.

The US regulation is not worded as a measure naming the Biofibre® 4.0 brand: it governs the category of prosthetic hair fibers intended for implantation in the scalp. To avoid misinterpretation, the regulatory status of Biofibre® must be described separately for each market on the basis of up-to-date regulatory documentation.

It is not correct to regard all generations of artificial fibres as technologically identical. Later literature describes the development of materials, techniques, systems and medical implant protocols that differ from some of the technologies historically associated with the complications of the 1970s and 1980s. This does not remove the need to assess the risks and benefits of modern technologies on the basis of current clinical evidence.

Regulatory status can vary by market and must be checked against 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 notified body 0373 - Istituto Superiore di Sanità.

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

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