2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
FDA Comment Number : EC18
Submitter : Ms. meg mclain Date & Time: 12/09/2005 04:12:58
Organization : Ms. meg mclain
Category : Individual Consumer
Issue Areas/Comments
Experience has taught me the effectiveness of condoms. Although I have been HIV+ for nearly a decade I have not passed along the virus to any partner. I know how to use a condom, I know the benefits of condoms and also the public opinion of HIV infection (as well as those infected).

I recall a few years back when HIV+ patients were informed to ONLY use N-9 condoms. Now it is known that this chemical can cause irritation that creates outlets for HIV to enter the body. This does not happen in every case. Using a condom with N-9 is better than nothing at all. N-9 does not lead to HIV infection; it only provides a route for infection to possibly occur. The proposed statement gives the impression that N-9 should be avoided at all cost. If this was the case the CDC prior recommendation would have been disastrous.

In addition although providing additional pregnancy and STD information on an insert is useful, the proposed labeling (external) is overly verbose. At the very least this will lend to the information being completely ignored, at the very worse, the product in general.

Condoms are effective and can be more effective then some forms of 'abstinence' (i.e. certain mutual masturbation behaviors as well as youth perceiving oral sex as not sex at all). Don't scare the public away from condoms. Religion should not direct science. Neither should politics.