What it is
Amniotic products are made from tissue donated after childbirth, such as the amniotic membrane or amniotic fluid. They are processed and sold in several forms. Some are sheets used as a wound covering or on the surface of the eye, and others are liquids or powders meant to be injected.
Using amniotic membrane as a wound covering and on the eye surface is the established use. Injectable amniotic, umbilical cord, Wharton's jelly and exosome products for joints, pain, hair, skin or 'regeneration' are a different matter. They are generally not FDA-approved for those uses, and the FDA has warned the public about unapproved regenerative products.
You may see these products described as stem-cell treatments. Most contain no living stem cells after processing, so the label can be misleading. Asking exactly what a product contains is a fair and sensible question.
How it’s traditionally been approached
Joint, tendon and muscle discomfort has traditionally been approached in many ways. These include rest, physical therapy, movement and strength work, over-the-counter or prescribed medicines, other injections, and sometimes surgery. Which of these are appropriate depends on the person and on a clinician's evaluation.
Injectable biologic products, including those from amniotic tissue, are a newer area that some clinics offer. Because most are not FDA-approved for these uses, the evidence, the quality of products and the claims made about them can vary a lot from one place to another.
Many people compare options by talking with more than one provider. Getting a second opinion is a common and reasonable step, especially with a procedure that may not be covered by insurance.
How the right doctor may help
A licensed provider, such as an orthopedic or sports medicine doctor or a doctor at a regenerative medicine clinic, may be able to evaluate your situation and explain the full range of options. That can include options that don't involve an injection at all. A visit generally begins with your history, a conversation about your goals and an exam. Imaging may be discussed if the provider thinks it's appropriate.
Good questions to bring include these. Is this product FDA-approved for what I'm being offered it for, and if not, what is its regulatory status? Where does the tissue come from, and how is it processed? Does it contain living cells? What are the possible risks and side effects? What are the alternatives, including doing nothing for now? What is the total cost, including follow-up visits, and will insurance cover any of it?
It's also fair to ask how the provider will measure whether something is helping, and what they would do if it doesn't. Only a licensed clinician can decide what is appropriate for you after an evaluation. A thoughtful provider should welcome your questions and not pressure you to decide on the spot. No provider can promise a result.
The whole-person view
Body, mind and stress affect one another. Ongoing pain can weigh on mood and sleep, and stress can make discomfort feel stronger. Looking at the whole person, including movement, rest, daily habits and emotional wellbeing, can give you a fuller picture when you weigh your choices.
Some people find that body-based support such as Somatic Experiences helps them tune in to how stress shows up physically. Others find that talking with a therapist through Therapists.plus helps them cope with the worry and uncertainty of a health decision. These are supportive options to consider alongside, not instead of, guidance from your doctor.
Somatic Experiences: nervous system regulation →Somatic Experiences: embodiment and movement →Therapists.plus: mind body connection →
Keep in mind
- Most injectable amniotic products are not FDA-approved for joint, pain, hair, skin or regeneration uses, so ask any provider about a product's regulatory status.
- Only a licensed clinician can decide what is appropriate for you after an evaluation, and results can never be promised.
- Ask about tissue source, risks, alternatives and total cost, and check with your insurance before treatment.
- Licensed professionals should guide care for serious conditions. For emergencies call 911, and in a crisis call or text 988.
Not sure where to start? Answer a few gentle questions and choose who you’d like to hear from.
Frequently asked questions
What questions should I ask before an amniotic injection?
Ask whether the product is FDA-approved for the use being offered, and what its regulatory status is. Also ask where the tissue comes from, whether it contains living cells, what the risks are, what the alternatives are, and what the total cost will be. It also helps to ask how success is measured and what happens if it doesn't help.
Are amniotic injections FDA-approved?
Injectable amniotic products for joints, pain, hair, skin or 'regeneration' are generally not FDA-approved for those uses. The FDA has warned the public about unapproved regenerative products. Ask your provider about the specific product's status and what that means for you.
Are amniotic injections stem-cell treatments?
No, they shouldn't be described that way. Most amniotic products contain no living stem cells after processing. If a clinic uses that term, ask them to explain exactly what is in the product.
What are the risks of an amniotic injection?
Any injection can carry risks, and unapproved products may have less established safety information. Your provider should explain the possible risks that apply to you after an evaluation. Ask them to put that information in writing if you can.
Will insurance cover an amniotic injection?
Coverage often depends on the plan, and many insurers don't cover products that aren't FDA-approved for the intended use. Contact your insurance company before treatment. Also ask the provider for the total cost, including follow-up visits.
Who should I talk to about an amniotic injection?
A licensed provider such as an orthopedic or sports medicine doctor or a regenerative medicine clinician can evaluate your situation and talk through your options. Consider a second opinion before deciding. You can use Providers.plus to find licensed providers.
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.