Medical Tourism for Unproven Treatments
What US, EU, Canadian and UK official sources say about traveling abroad for unproven treatments, what is known about complications, and which questions to ask first.
Content last updated . This page has not been medically reviewed.
If you feel unwell after a treatment
Get medical care right away if you become seriously unwell after a procedure, at home or abroad, and tell the clinicians exactly what was given and where. In the United States, call 911 for an emergency. The FDA lists infection, vision loss and tumor formation among the problems reported after unapproved regenerative products. [1] Reporting is covered at the end of this page.This page is information only. It does not recommend or rule out any clinic or country, and it is not legal advice.
What "unproven" means here
Medical tourism means traveling to another place for care. Much of it is routine and legitimate. This page is about one part of it: trips to buy a treatment that has not gone through the regulatory process in the place where it is sold, or that is described as "experimental" but is not part of an authorized trial. The International Society for Stem Cell Research (ISSCR) defines an unproven stem cell treatment as one that has not undergone the proper regulatory process, unlike an investigational treatment tested in a clinical trial with oversight. [2] It also says a treatment offered for sale is not the same as a clinical trial. [3]Evidence labels used on this site are explained in how we label evidence. A clinic offering a treatment is not evidence that it works or is approved.
What official sources say, by jurisdiction
| Jurisdiction | Source and date | What it says |
|---|---|---|
| United States (FDA) | Patient and consumer information, June 2021, current as of April 2024 | Unapproved regenerative products are broadly marketed. If you are charged for them or offered them outside a clinical trial, the FDA says you are likely being deceived and offered a product illegally. [1] |
| United States (FDA) | Exosome safety notification, December 2019 | There are currently no FDA-approved exosome products. [4] |
| European Union (EMA and the Heads of Medicines Agencies) | Statement on unregulated advanced therapies | Unregulated advanced therapies may cause serious side effects without proven benefits and are often sold online "as a last hope." [5] |
| Canada (Health Canada) | Information update, May 15, 2019 (older; check for newer notices) | All cell therapies are considered drugs under the Food and Drugs Act, and most cell therapies are still experimental. [6] |
| United Kingdom (government Travel Aware campaign) | Undated campaign page | Traveling abroad for treatment can significantly increase the risk of something going wrong. [7] |
Other countries were not verified. Rules differ and change, so check the national regulator where any treatment would be given.
What changes when you cross a border
The FDA says it does not have oversight of treatments done in other countries. [4] In a country that may not require regulatory review of clinical studies, it may be hard to know if an experimental treatment is reasonably safe. [4]The UK government campaign adds practical points. Regulatory standards may be different, so do not assume they match those at home. [7] It advises agreeing the plan with your own doctor before consulting a foreign one. [7] It warns that most travel insurance policies will be invalidated by planned treatment abroad. [7] And it advises getting a full medical report in English to bring back to your own doctor. [7] Those points are written for UK residents and for surgery in general, but the follow-up problem applies to any treatment given far from home.
Money and future options also matter. The ISSCR notes that insurers and government programs usually do not cover experimental treatments. [3] It also says receiving one unproven treatment may make you ineligible for future clinical trials. [3]
What studies of complications abroad do and do not show
No source we read measures how often unproven treatments abroad cause harm. What exists is case-based:- A review of reported adverse events after unproven stem cell interventions looked at published case reports and media reports and discussed the growth of "stem cell tourism." [8] Case reports show that harm can happen, not how often.
- A 2024 policy review says unproven cell-based interventions can harm patients physically and financially. [9]
- For cosmetic surgery abroad, a systematic review of 44 studies identified 589 patients with complications, most often infection. [10] Another review found 370 patients with infections, with gluteal augmentations linked to the highest number of severe cases. [11] These reviews cover approved types of surgery done abroad, not unproven treatments, and count cases without a denominator of everyone who traveled.
Questions to ask before any decision
- Is this approved where it is given, or inside an authorized clinical trial? Can I see the approval or trial record? In the US the FDA suggests asking for the Investigational New Drug (IND) number. [4]
- Can I contact the national regulator to verify it? The EMA advises contacting your national competent authority to verify approval. [5]
- Who covers follow-up care and complications at home?
- Does my own doctor know the plan? See informed consent in emerging treatments.
Reporting a problem
In the US, report adverse events to the FDA's MedWatch program. [1] In Canada, adverse events from health products, including unauthorized cell therapies, can be reported to Health Canada. [6] More is in adverse-event reporting for emerging products. For the cell-therapy details see unapproved clinics and medical tourism for cell therapies and regulatory status of regenerative products.Frequently asked questions
Is medical tourism always risky or unproven?
No. This page covers only treatments that are unapproved or unproven where they are sold. Official sources still say that treatment abroad adds risks such as different standards and harder follow-up. [7]
Does a clinic being registered with a regulator mean the treatment is approved?
Not necessarily. The FDA says a firm registering and listing a product does not mean the product is legally marketed. [1]
Are there approved stem cell products?
Yes, but narrowly. The FDA's 2020 consumer alert said the only approved stem cell products were blood-forming cord blood products. [12] Check the current FDA list and the regulatory-status page, because approvals change.
Does my own doctor need to know?
Official guidance says to talk it through. The UK campaign advises agreeing treatment with your own clinician first. [7]
What if a clinic says its treatment is "a clinical trial"?
Ask for the registration and the regulator's authorization. The ISSCR says an experimental treatment offered for sale is not the same as a clinical trial. [3]
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Warning signs described by regulators and societies
- The provider markets a product as experimental but uses it outside an authorized clinical trial, or cannot confirm that it is approved. [5]
- One cell type is offered for many unrelated conditions. The ISSCR says this is unlikely to work. [3]
- Marketing relies on testimonials. Feeling better can come from other factors than the treatment itself. [3]
- An advert that guarantees complete success. The UK government campaign says this should raise concerns. [7]
- The clinic points to a trial registry entry or an FDA registration as proof. The FDA says a firm registering and listing a product does not mean it is legally marketed. [1]
References
- U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies (posted June 3, 2021; content current as of April 8, 2024). Read 2026-10-22.
- International Society for Stem Cell Research (ISSCR). Unproven Treatments (patient information page, undated). Read 2026-10-22.
- International Society for Stem Cell Research (ISSCR). Nine Things to Know About Stem Cell Treatments (patient information page, undated). Read 2026-10-22.
- U.S. Food and Drug Administration. Public Safety Notification on Exosome Products (December 6, 2019). Read 2026-10-22.
- European Medicines Agency. Advanced therapy medicinal products: overview, including the EMA/HMA statement on risks of unregulated advanced therapies (page read as published). Read 2026-10-22.
- Health Canada. Health Canada is advising Canadians about the potential health risks associated with unauthorized cell therapy treatments such as stem cell therapy (information update, May 15, 2019). Read 2026-10-22.
- UK Government (Foreign, Commonwealth and Development Office) Travel Aware campaign. Surgery abroad, cut out the risk (undated campaign page). Read 2026-10-22.
- Bauer G, Elsallab M, Abou-El-Enein M. Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions. Stem Cells Transl Med. 2018;7(9):676-685. Read 2026-10-22.
- Brinsfield TN, Pinson NR, Levine AD. The evolution and ongoing challenge of unproven cell-based interventions. Stem Cells Transl Med. 2024;13(9):851-858. Read 2026-10-22.
- Alkaelani MT, et al. Complications of Medical Tourism in Aesthetic Surgery: A Systematic Review. Ann Plast Surg. 2023;91(6):668-673. Read 2026-10-22.
- Gilardi R, et al. Infective complications of cosmetic tourism: A systematic literature review. J Plast Reconstr Aesthet Surg. 2023;84:9-29. Read 2026-10-22.
- U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes (dated July 22, 2020; content current as of April 9, 2024). Read 2026-10-22.