What it is
Amniotic products are made from tissue donated after a healthy birth, such as the amniotic membrane, amniotic fluid, umbilical cord or Wharton's jelly (the jelly-like material inside the cord). Companies process, preserve and package these materials in different ways, so products can vary quite a bit.
The best-established use is amniotic membrane applied as a wound covering and on the surface of the eye. That is quite different from injectable amniotic, umbilical cord, Wharton's jelly or exosome products marketed for joints, pain, hair, skin or so-called regeneration.
Those injectable products are generally not FDA-approved for those uses, and the FDA has warned the public about unapproved regenerative products. Despite popular claims, most amniotic products contain no living stem cells after processing, and they should not be described as stem-cell treatments or as regrowing cartilage or tissue.
How it’s traditionally been approached
In the United States, the FDA regulates human cells and tissue products. Some minimally processed tissues used in a similar way to how they function in the body may be treated differently from products that are altered or used for a different purpose, which are often regulated more like drugs or biologics that need FDA approval.
Over the years the FDA has issued public warnings and letters about certain regenerative products, including some amniotic and umbilical cord products promoted for conditions they have not been approved to treat. Patients have been encouraged to ask questions before agreeing to any such product.
Tissue banks that recover and process donated tissue may also seek voluntary accreditation from professional bodies, which looks at screening, handling and record keeping. Accreditation is one thing worth asking about, but it is not the same as FDA approval of a product for a particular use.
How the right doctor may help
A licensed clinician may help you sort through marketing claims by reviewing your history, examining you and talking through what is and is not supported for your situation. A visit usually starts with your questions, your symptoms and what you have already tried. Whether any product is appropriate is a decision only a licensed clinician can make after an evaluation.
Before any amniotic injection, it can help to ask: Is this product FDA-approved for this use, and if not, what is its regulatory status? What is the tissue source, and which tissue bank processed it? What are the possible risks and side effects? What are the alternatives, including options that are not injections? What is the total cost, and will insurance cover any of it?
It also helps to ask how the provider will explain results honestly, since no outcome can be promised. A thoughtful provider should welcome these questions, give clear answers and let you take time to decide. If answers feel vague or pressured, consider a second opinion.
The whole-person view
Body, mind and stress affect one another. Ongoing pain or a skin or hair concern can bring worry and frustration, and stress can in turn change how the body feels. That can make bold promises sound especially appealing, so a whole-person view and a calm pace can help you decide well.
Some people explore body-based support such as Somatic Experiences to build awareness of how stress shows up in the body, and others find talk therapy through Therapists.plus helpful for coping with a long health journey. These are supportive options, not replacements for care from a licensed provider.
Somatic Experiences: nervous system regulation →Somatic Experiences: embodiment and movement →Therapists.plus: mind body connection →
Keep in mind
- Most injectable amniotic and umbilical cord products for joints, pain, hair or skin are generally not FDA-approved for those uses, and the FDA has warned the public about unapproved regenerative products.
- Licensed professionals should guide care for any serious condition, and only a licensed clinician can decide what is appropriate after an evaluation.
- Ask about FDA status, tissue source, risks, alternatives and total cost, and check with your insurance before any treatment.
- For an emergency, call 911. In a crisis, call or text 988.
Guides in this topic
Doctor types
Frequently asked questions
Is an amniotic injection FDA approved?
Generally, no. Injectable amniotic, umbilical cord and Wharton's jelly 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 regulatory status.
What is the FDA amniotic products warning about?
The FDA has warned the public about unapproved regenerative products, including some amniotic and umbilical cord products promoted for conditions they have not been approved to treat. The concern is that claims may outpace evidence and that safety may not be well established. Ask a licensed provider about any product before agreeing to it.
What are the possible amniotic injection side effects?
Side effects depend on the product, the person and the injection site, and a licensed clinician can explain what applies to you. Injections in general can carry risks such as pain, swelling, infection or an unwanted reaction to the material. Because many of these products are unapproved, their risks may be less well understood, so ask about this directly.
What are the main amniotic injection risks?
Risks may include reactions to the product, infection, and the chance that it simply does not help. There is also the risk of paying out of pocket for something not covered by insurance. A provider can explain the risks and alternatives for your situation after an evaluation.
What questions should I ask before an amniotic injection?
Ask whether the product is FDA-approved for your use, where the tissue came from, and which tissue bank processed it. Also ask about risks, alternatives, expected follow-up and the total cost, and check your insurance first. A good provider will answer plainly and give you time to decide.
Are amniotic products really stem-cell treatments?
No, this is a common myth. Most amniotic products contain no living stem cells after processing, and they should not be described as stem-cell treatments. They also should not be said to regrow cartilage or tissue, and no results can be promised.
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.