[URL="http://www.industryleadersmagazine.com/risug-the-single-dose-safe-revers..."]RISUG. The Single dose, Safe, Reversible Contraceptive Method for Men
[QUOTE]"Currently under advanced trials in India, where some men have used it successfully for over 15 years, RISUG offers results which are similar to a traditional vasectomy but with added advantages of the process being simple, relatively pain free and easily reversible.
Men who wish to reverse the procedure and restore fertility at any point after choosing this contraceptive method, can do so easily with the polymer being able to get flushed out of the system with another injection."[/QUOTE]
[QUOTE]Through the trials carried out by Guha’s team across hundreds of men, RISUG was found to be 100% effective, with no failures or serious adverse reactions reported by any of the subjects. The procedure now being in late Phase III clinical trials in India means that usage of this drug could be approved in India in as little as two years.[/QUOTE]
[QUOTE]a small American foundation called Parsemus has purchased the rights to begin RISUG (Vasagel) clinical trials in the U.S starting next year. Parsemus hopes to launch the product in the U.S market by 2015.[/QUOTE]
Weasel,
I am glad you are following this story with, now, multiple posts on Vasalgel/RISUG. Some of us have seen multiple drugs for male contraception reach this stage and, ultimately not be approved. Yjid hsd been spproved already in a few South Asian countries and, as you indicate, is going into final clinical testing in India with a small American foundation trying to get early trials going in the U.S.
Like most drugs or devices, whatever this would be called, there have been some problems along the way. These problems have slowed the Indian studies and have made more developed nations' drug agencies wary. This works by injecting a substance into the vas deferens that forms a plastic blockage to the vas - tubes that deliver sperm from the testes to the prostate. The reversal is via another injection that dissolves the plug. Some problems include that testes have been found to stop producing sperm in vasectomy patients over time; the chemical used to dissolve the plug can cause kidney damage; and, the long term effects of the plastic in the vas deferens are still no known.
Remember the uproar over silicone breast implants bursting? Yet none of the damaging effects were ever directly linked to the silicone. That was for a cosmetic procedure, so you can imagine approving agencies hesitancy in allowing other plastics to be injected - especially in a place that has been shown to result in some damaged sperm in ejaculate.
Certainly, U.S. FDA approval is a greatly encouraging sign but these trials were halted for four years in India. Similar problems could still lie ahead.