Seriously? This is not a major issue. If you want to hammer the FDA, they have given you so much more to go with than this bull.

This is a bit of a "head scratcher." It is true that the warning seems to suggest that the condoms may NOT be effective, but that appears to be more a function of the government somewhat arbitrarily deciding to create a new category because the Avanti condoms are polyurethane, rather than latex.

I suppose it is conceivable that the different material might pose an increase threat of slipping or breaking, but I also don't see any convincing rational to assume this. There are also some scientific measures one could employ to compare the two materials in terms of tensile strength and coefficients of friction against flesh. I have handled Avanti condoms before and actually found them to be stronger than latex, although this is hardly a rigorous comparison.

It is conceivable that some unforeseen problem could arise with Avanti condoms, but unless there is a convincing rationale to believe slippage or breakage is more likely to occur, I don't see any convincing reason to do clinical trials for every possible condom variation. I, for example, have no idea if the alternate colored condoms, or the ones with "ribs for her pleasure" or whatever have been panstakingly tested and found to be precisely as effective as standard, run of the mill latex condoms.

All this to say, I think there are more pressing issues to worry about than more testing for condoms that fall "within the normal range" of condom reliability.

Rob, just because something may not be - in your opinion - a "major issue" doesn't mean it shouldn't be covered or paid attention to.

And I think anyone who got pregnant or contracted an STD after using one of these condoms would certainly consider it a major issue.

I believe these condoms are primarily intended for those with a latex allergy.

In the case of those people I would think that the risk of the unknown would outweigh the risk of NOT having any type of condom that you can use.

Maybe for many people it would be prudent to wait until the product is fully tested, but try telling that to a teenage kid who is allergic to latex. I'm pretty sure that they would take their chances one way or the other (either on this condom or on not using one...)

I think the approach that was taken (bringing it to market with a warning) is completely reasonable.

I think the more examples of FDA inaction for public health, the better. Condoms, tomatoes, prescription pills - it all paints a picture of bad governance.

This is one of those items that allows one to put something into context. Understandably the argument can be made that the FDA really has made some monumental screw-ups (roofie laced aqua toys being the best!); but to use a car analogy, we know the FDA has practically seized up the engine of the agency, but do they kick the tires? The inconsistencies inherent with a system that has a black box warning opposed to a simple printed warning or whether the warning must be in a different color ink is akin to a situation where possibly the person took really nice care of the car's exterior but forgot to add oil. The durex situation simply tells me that the current caretakers of the FDA don't even try to wash the car--or course why would you when the vehicle is up on blocks?

Something that needs to be addressed in this situation is the reaction on abstinence-only sex education crowd. They have continued to lie and obfuscate the value of using condoms for both birth control and STD prevention. Seeing an announcement of "The risks of pregnancy and sexually transmitted diseases (STD's), including AIDS (HIV infection), are not known for this condom." will give credence to their propaganda that "condoms don't work - see, it's right there on the package".

It's actually a non-issue. Someone trying to make a story out of nothing. The condoms work fine, other condom makers have gone through the regulatory testing, the durex people make them the same way, to the same specifications. This company would be lawsuit toast already if the condoms didn't work. All this article is about is semantics of the wording on the box. The company is just doing a little CYA, which is basically all the healthcare industry is anymore.

The box also says "There are laboratory tests on this non-latex material. These texts show that organisms even as small as sperm and viruses like HIV cannot pass through it."

It's distressing to me that a condom manufacturer would release a product that they weren't sure was able to function as it is supposed to.

I like One Condoms (onecondoms.com) No worry about whether or not they work or if the company has something to hide in the "fine print".

the warning on the label is so they will get out of any lawsuits due to std or pregnancy. that is why its there.