What it is
Amniotic products come from tissue associated with pregnancy, such as the amniotic membrane or amniotic fluid, usually donated after a planned birth. After collection, the tissue is processed in different ways, and the final products can look very different from one another.
The established, longstanding use of amniotic membrane is as a covering for wounds and on the surface of the eye. These are topical or surface uses, and they are not the same as an injection into a joint, the skin or the scalp.
Injectable amniotic, umbilical cord, Wharton's jelly and exosome products are often promoted for joints, pain, hair, skin or "regeneration." In general, these are not FDA-approved for those uses. Most also contain no living stem cells after processing, so calling them stem-cell treatments is inaccurate.
How it’s traditionally been approached
Amniotic membrane has traditionally been used by clinicians as a biological covering for certain wounds and for the eye's surface. This is the use most people mean when they say amniotic tissue has a track record.
In recent years, some clinics have offered injectable amniotic-derived products as part of regenerative medicine. Marketing for these products varies widely, and the claims made are not always matched by FDA review.
The FDA regulates human tissue and cell products according to how they are made and what they are claimed to do. Because of this, a product's regulatory status can differ depending on its processing and intended use, which is why it's worth asking directly.
How the right doctor may help
A thoughtful provider, such as an orthopedic or sports medicine doctor or a clinician at a regenerative medicine clinic, may begin by listening to your history, examining the area of concern and discussing what you hope to achieve. Only a licensed clinician can decide what is appropriate for you after an evaluation.
If an amniotic injection comes up, a good provider may be willing to explain what the product is, whether it is FDA-approved, and whether it is being offered as part of a clinical study or outside of approval. They may also talk through more established alternatives.
Helpful questions to ask: What is this product's FDA status for my condition? What is the tissue source and how was it processed? What are the possible risks and side effects? What alternatives exist? What is the total cost, and does my insurance cover any of it? Getting answers in writing before treatment can help you decide with confidence.
The whole-person view
Body, mind and stress influence one another. Ongoing pain or a slow recovery can affect sleep, mood and motivation, and stress can in turn make physical discomfort feel more intense. Looking at the whole person can help you weigh options without feeling rushed by hopeful marketing.
Some people find that body-based support such as Somatic Experiences helps them tune into how stress shows up physically, while talk therapy through Therapists.plus can offer a space to process worry about health decisions. These are complements to, not replacements for, a licensed provider's guidance.
Somatic Experiences: nervous system regulation →Somatic Experiences: embodiment and movement →Therapists.plus: mind body connection →
Keep in mind
- The FDA has warned the public about unapproved regenerative products, so always ask a provider about a product's approval status before treatment.
- Results are never guaranteed, and an amniotic injection should not be assumed to replace or avoid other care, including surgery.
- Licensed professionals should guide care for any serious or worsening condition. For emergencies call 911; in a crisis call or text 988.
- Check the total cost and your insurance coverage in advance, since unapproved uses are often not covered.
Not sure where to start? Answer a few gentle questions and choose who you’d like to hear from.
Frequently asked questions
Is amniotic injection FDA approved?
In general, no. Injectable amniotic products marketed for joints, pain, hair, skin or regeneration are not FDA-approved for those uses. Amniotic membrane as a wound covering and on the eye surface is the established use. Ask your provider about the specific product's status.
Has the FDA warned about amniotic and regenerative injections?
Yes. The FDA has warned the public about unapproved regenerative medicine products, including some made from amniotic and umbilical cord tissue. It's wise to ask any clinic how a product is regulated before agreeing to treatment.
Are amniotic injections stem-cell treatments?
No, they should not be described that way. Most amniotic products contain no living stem cells after processing, and they should not be said to regrow cartilage or other tissue.
Is amniotic membrane FDA approved for anything?
Amniotic membrane has an established use as a wound covering and on the surface of the eye. These uses differ from injections, and regulatory details can vary by product, so a provider can clarify what applies.
Will insurance cover an amniotic injection?
Often not when the use is unapproved, but coverage varies by plan and situation. Check with your insurer and ask the provider for the total cost before treatment.
What should I ask a doctor before getting an amniotic injection?
Ask about the product's FDA status, its tissue source, the possible risks, the alternatives and the total cost. Also ask whether it is part of a clinical study. A licensed clinician decides what is appropriate after an evaluation.
Educational resource. Amniotic Doctors shares general information and connects people with independent doctors. It is not medical advice, diagnosis or treatment. Talk with a licensed professional about your health.