Being pricked by tiny needles may sound like a strange way to make your skin look better, but that’s the concept behind a skin care technique called microneedling. People are using microneedling in a variety of ways from reducing scarring, to treating fine lines and wrinkles. It is important to be aware of the risks as well as benefits associated with microneedling devices.

If you are thinking about having a microneedling procedure, the U.S. Food and Drug Administration recommends you choose a health care provider who is specially trained in microneedling. Talk with the provider to determine if you are a good candidate for microneedling—not everyone is. Discuss the benefits and risks, including the risk of infection if the microneedling tools are not cleaned or used properly.

Microneedling devices are instruments with technological features, such as many small needles, tips, or pins on the surface, which are repeatedly inserted and removed into the skin. For example, the needles may be attached to a cylinder that is rolled across the skin, project from a flat surface that is "stamped" on the skin, or arranged in a pattern on the tip of a pen-shaped instrument.

Microneedling devices create many small puncture holes in the skin by moving over the skin repeatedly. Some microneedling devices are manual, meaning the needles always project from the surface, and they enter the skin when the device is rolled or stamped on the surface. Other devices use a motor to move needles in and out of the device surface. In some motorized devices, the health care practitioner can adjust and control the depth and speed of penetration of needles into the skin.

The FDA regulates microneedling products that are medical devices to make sure they are safe and work as claimed. Not all microneedling products are medical devices.

Microneedling products that are medical devices

The FDA has cleared microneedling devices for use as a treatment to improve the appearance of facial acne scars, facial wrinkles, and abdominal scars in patients aged 22 years or older.

Most of the cleared devices are pen-shaped, motorized and penetrate the skin in order to change the structure or function of the tissue below. Because these devices may reach nerves, blood vessels and other parts of the skin, the FDA recommends you go to a health care provider with special training in microneedling.

The FDA has not authorized any microneedling medical devices for over-the-counter sale.

Microneedling products that are NOT medical devices

Generally, if a microneedling product does not have longer needles or sharp needles that penetrate the skin and only claims to facilitate exfoliation of the skin or improve the appearance of skin, it would not be a medical device regulated by the FDA. A dermal roller with short, blunt needles that only claims to help remove dead skin and smooth and brighten your skin would be an example. These products are more commonly sold for use at home.

While there are several types of microneedling products, they all have a key feature—they contain lots of small, thin needles. The needles may be:

• Fitted onto a cylinder and rolled across the skin (known as a dermal roller)
• Attached to a flat surface and stamped into the skin
• Arranged in a pattern on the tip of a pen-shaped instrument

Some products have needles that are so short they only touch the topmost layer of the skin, which is mainly dry, dead skin. Other products have longer needles that penetrate the skin and reach deeper layers that have living cells, nerves, and blood vessels.

The products may be manual, meaning they are operated by hand, or they may have a motor that moves the needles.

The FDA has legally authorized microneedling devices to improve the appearance of facial acne scars, facial wrinkles, and abdominal scars in patients aged 22 years or older. This means the FDA has reviewed data to support a reasonable assurance of the safety and effectiveness of these devices for these uses.

• Summary documents for De Novos which have been granted or 510(k)s which have been cleared are publicly available on FDA's website. To view these De Novo Decision Summaries or 510(k) Summaries, please check the following databases:
  • De Novo database and search for specific devices or De Novos in the General and Plastic Surgery Panel
  • 510(k) database and search for specific devices or the product code, QAI
• To date, the FDA has only granted marketing authorization for a limited number of medical devices for specific uses in specified areas of the face and body. The FDA may not have reviewed the use of certain microneedling devices for all locations in the body. The public summary links above specify the intended areas of the face and body for each legally-marketed microneedling device.

Some microneedling products may not be medical devices. For example, generally, microneedling products that do not penetrate into the living skin layers (epidermis and dermis) and claim only to do the following would not be devices:

• Facilitate exfoliation of the skin (that is, disruption or removal of the stratum corneum)
• Improve the appearance of skin
• Give skin a smoother look and feel
• Give skin a luminous look

The FDA has cleared microneedling devices for use on women and men aged 22 and older as a treatment to improve the appearance of:

• Acne scars on the face
• Wrinkles around the eyes and other parts of the face and neck
• Surgical scars on the abdomen

Any microneedling device has the potential to cause side effects that last a short time or a long time.

Skin damage is a risk that commonly occurs with microneedling devices. The damage may include bleeding, bruising, redness, tightness, itching and peeling, and these typically go away without any treatment after a few days or weeks.

Less common risks include stinging or itching when cosmetics or other skin care products such as moisturizers and sunscreen are applied, dark or light spots on the skin, lines on the face, a flareup of cold sores, swollen lymph nodes, and infection.

Be aware, microneedling may not always result in the desired aesthetic outcome and it may take more than one procedure to get the results you are seeking. In addition, any improvement in appearance may be temporary and maintenance may require additional procedures over time.

As with any medical procedure, there are risks involved with the use of microneedling devices. That is why it is important for you to understand their limits and possible risks.

Any microneedling device has the potential to cause side effects that last a short time or a long time. Some side effects may be permanent. However, most side effects associated with microneedling occur shortly after a treatment and resolve. Microneedling procedures may not always result in the desired aesthetic outcome.

The following risks are associated with FDA-authorized uses of microneedling devices.

Common risks include:

• Dryness
• Rough skin
• Tightness
• Redness
• Itching
• Peeling
• Discomfort
• Burning
• Bruising
• Bleeding
• Crusting

Less common risks include:

• Pigmentation changes (increase in pigment (hyperpigmentation) or loss of pigment (hypopigmentation)
• Lines on the face
• Reactivation of herpes cold sores
• Swollen lymph nodes
• Infection
• Stinging or itching when cosmetic products are applied

The risks associated with other uses ("off label uses") of microneedling devices, the combination of microneedling devices with other products, or the use of microneedling products that have not been evaluated by the FDA are not known.

If you are considering a microneedling procedure, the FDA recommends that you:

• Talk to your health care provider regarding the anticipated benefits and risks associated with treatment.
• Select a health care provider who is trained to perform microneedling procedures. Ask your health care provider about his or her training and experience with microneedling.
• Be aware that microneedling may be considered a medical procedure, not a cosmetic procedure, when it meets the definition of a medical device, for example, if intended to change the structure or function of tissue. There are also risks, which are listed above. Microneedling devices are not approved for delivery of cosmetics, topical medications (for example, creams, ointments, gels), vitamin solutions, drugs, or blood products (for example, platelet-rich plasma (PRP)) into the skin.
• Be aware that you may need more than one procedure to get the desired aesthetic improvement.
• Ask your health care provider how the device is cleaned between patients.
• Ask your health care provider whether a new microneedle cartridge is used for each patient, and for each treatment session for the same patient. Re-use of the needle cartridge is unsafe and is not consistent with the FDA's review and authorization, even if the cartridge is cleaned.
• Ask for patient labeling which is available with FDA-authorized microneedling devices.

The procedure may NOT be suitable for you if you:

• Have a known history of clotting or bleeding disorders such as hemophilia.
• Are immune deficient or immune suppressed due to medical conditions or medications.
• Suffer from uncontrolled diabetes (high blood sugar).
• Take anticoagulant (blood thinner) therapies such as warfarin,heparin, or low dose aspirin.
• Suffer from an active skin infection, including bacterial, viral, or fungal infection.
• Suffer from an infection such as hepatitis or human immunodeficiency virus (HIV).
• Have or had eczema, psoriasis, vitiligo, or auto-immune disease.
• Have an active rash on the face.
• Have a current outbreak of cold sores (herpes).
• Are currently taking acne medication with the ingredient isotretinoin (Accutane) or have taken isotretinoin in the past 6 months.
• Have actinic (solar) keratoses, keloid scars (or a history of keloid scars), warts, , or birthmarks or moles in the treatment area.
• Have darker skin type, as there is a risk of darkening or lightening of the skin after the procedure. Some of the devices authorized for marketing by the FDA were not studied in subjects with darker skin types.
• Are tan or planning to be in the sun in the two weeks following the procedure.
• Suffer from a known malignancy or are undergoing or about to undergo treatments using chemotherapy, radiotherapy, or steroids.
• Are pregnant or breastfeeding.
• Are allergic to stainless steel or to topical or local anesthetics or have a history of contact dermatitis to these products.

Microneedling is not suitable for everyone, so it’s important to talk with a health care provider. Be aware:

• Numbing medication (topical anesthesia) is typically applied to the skin before the procedure to help reduce pain during microneedling.  Tell your provider if you have any allergies or sensitivities to numbing medications.  
• Microneedling can cause bleeding so it may not be suitable for people with clotting or bleeding disorders, or who take medicine to thin their blood. 
• You may want to avoid microneedling if you have conditions that affect your skin, such as eczema or diabetes, or if you have a weakened immune system.
• Ask your health care provider how the microneedling device is cleaned between patients.  Microneedling devices that have reusable parts should be cleaned and disinfected according to the device instructions. 
• Ask your health care provider if a new needle cartridge is used for each patient and for each treatment session with the same patient. Re-using cartridges can cause or spread infection. 
• Ask your health care provider how to care for your skin after the procedure, as your skin may be more sensitive to the sun and to skin care products like sunscreen, makeup, and moisturizers, especially products that contain retinol, glycolic acid, menthol, capsaicin or alcohol.  
• If you have a microneedling product for home use, clean it between uses as directed by the manufacturer.  Do not share these products with other people to avoid possible infection or spreading disease.

The FDA has cleared devices with microneedles that deliver radiofrequency (RF) energy (heat) for the treatment of facial wrinkles and other treatments. There are different risks with RF microneedling devices, as they work differently.

You may have heard about microneedling being used to combat hair loss. While clinical studies may be going on, the FDA has not cleared any microneedling devices for this use.

You may be aware of microneedling products used along with creams, ointments, other drugs or cosmetics, or platelet-rich plasma. The FDA has not cleared any microneedling devices for use with another product, which means the FDA hasn’t reviewed the safety or effectiveness of combining microneedling devices with other products. The FDA’s web section on microneedling devices has more information on recommendations for patients and health care providers.

• Use only FDA-authorized microneedling devices. The FDA urges health care providers to inspect all microneedling packages for authenticity and check if the microneedling device that you have purchased is listed in the FDA's De Novo database or 510(k) Premarket Notification database.
• The FDA is aware of several microneedling devices that are not legally marketed. The safety and effectiveness of these devices has not been reviewed by the FDA.
• Do not use microneedling devices if you do not have the appropriate training or experience.
• Follow all instructions regarding the cleaning and disinfection of microneedling devices.
• Do not reuse a microneedling cartridge or use a microneedling cartridge on more than one patient as this could cause transfer of infectious agents.
• Consider use of prophylactic antivirals in patients with a history of herpes simplex.
• Know the signs and symptoms of complications associated with microneedling devices and have an updated plan detailing how the patient will be treated should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment.
• Tell patients that they should seek immediate medical attention if they experience signs or symptoms of complications associated with microneedling devices.
• Educate facility staff and employees on how to assist patients calling with signs and symptoms of complications related to microneedling devices and on how to receive appropriate medical care.
• Report to the FDA and the manufacturer if you become aware of any serious adverse event associated with the use of microneedling devices, including infection, cross-contamination, and device malfunctions.
• Consider that there are many alternative treatments to a microneedling device, including lasers, other energy-based devices, chemical peels, and dermal fillers. Discuss the benefits and risks of each treatment option with patients.