The Sexual Medicine Society of North America (SMSNA) – an affiliated society of the ISSM – is concerned about the internet promotions and expense of Regenerative/Restorative therapies for Erectile Dysfunction and Peyronie’s Disease. The SMSNA strongly supports advancing health care delivery to patients with sexual dysfunctions. At the same time, the Society wants to warn consumers about the difference between investigational therapies and FDA approved therapies.
“Given the current lack of regulatory agency approval for any restorative (regenerative) therapies for the treatment of ED and until such time as approval is granted, SMSNA believes that the use of shock waves or stem cells or platelet rich plasma is experimental and should be conducted under research protocols in compliance with Institutional Review Board approval. Patients considering such therapies should be fully informed and consented regarding the potential benefits and risks.”
The complete Position Statement from the SMSNA can be found here.