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Why aren’t medical devices regulated like drugs?

BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5032 (Published 29 November 2018) Cite this as: BMJ 2018;363:k5032

Rapid Response:

Condoms as medical device Re: Why aren’t medical devices regulated like drugs?

Condoms as medical device

Fiona Godlee (1) reported that medical devices should be more evaluated before their medical use.

In gynecology we hav many satisfactory medical devices. For example, intrauterine devices, transobturator tape, Bakri balloon and others.

However, I agree that for some medical devices the benefits and risks are not clearly defined. Therefore the information for patients and health professionals is lacking.

For example, condoms are delivered in pharmacies and supermarkets. However they are medical devices. They are used as contraceptive methods but also to protect against sexually transmitted disease. They protect effectively against HIV but insufficiently against Human papilloma viruses (HPV). HPV are responsible for cervix cancers and the death of many thousands of women in the World. Unfortunately, condoms dot not protect sufficiently against HPV in healthy women but also after a conisation or hysterectomy for HPV lesions. Indeed, recurrences could occur from the vagina for patients who undergo a uterine surgical treatment.

Finally, even for basic medical devices, risks and benefits should be clearly exposed: information for health professionals and patients is essential.

Condoms should be more evaluated and improved to protect against Human papilloma viruses.

References

1. Godlee F. Why aren’t medical devices regulated like drugs? BMJ 2018;363:k5032

Competing interests: No competing interests

19 December 2018
Souhail ALOUINI
Obstetrician and Gynaecologist Surgeon
Regional Hospital Center of Orleans
14 avenue de l'hôpital, 45100, Orleans