Andro-switch has just been the subject of a marketing ban by ANSM, on the grounds that there would be no CE marking. What is it for, how does it work, and what to do if you have used it and have a side effect?
This is the story of a silicone ring that wanted to distribute the contraceptive load between men and women. Worn by men in the testicles, it would have a natural thermal contraceptive action. He temporarily maintains the testicles in a supra scrotal position, allowing the temperature of the testes to rise to body temperature, resulting in temporary and reversible infertility.
But the problem is that the small company that launched this ring has not yet obtained a “CE” mark, a guarantee of safety after clinical trials in other words. Thoreme specifies on its site the difficulty of obtaining this label for small structures. But the ANSM, which welcomes the initiative of this type of contraception, applies the law and prohibits the sale of this uncertified medical device, as well as its distribution as a preventive measure.
Precautionary measure
“In general, we are attentive to the so-called contraceptive methods or objects which, because of this claim, must imperatively have a CE marking, the only element making it possible to guarantee their performance and their safety of use”, states the ANSM in a recent press release.
As a precaution, the ANSM recommends not having children for a period of 6 months after its use, or to consult a doctor, urologist or andrologist if you use it. The agency points to another potential side effect, discomfort, pain, or difficulty urinating. She specifies that this device, insofar as it has not been the subject of clinical trials, can lead to an unwanted pregnancy, and potentially harm the fertility and health of users, for lack of evidence to the contrary.
Sources: Thorème, ANSM.
Also read:
- Towards a male contraceptive gel
- Contraceptive injection for men: a reality in 2020?
