Last week, we about a Food and Drug Administration’s Obstetrics and Gynecology Devices Panel meeting to consider approval of a female condom; the product (currently called the FC2) is similar to the existing Reality condom, but with a change in the material.
That panel met on Thursday and unanimously recommended (14-0) approval.
Research was presented on the device assessing mechanical failures (such as breakage and slippage) as compared to the original female condom which it will replace. The research suggests that the two products were very similar in these respects.
However, the FDA’s summary of the meeting indicates that “No clinical studies have been submitted to show FC2 effectiveness for pregnancy or STI risk reduction.” And the FC2 was approved under the condition that the label for the device “be revised to accurately reflect the extent of the evidence comparing FC1 and FC2.” The panel specifically noted that “clinical outcomes (i.e., pregnancy and sexually transmitted infections) had not been studied on FC2.”
What I don’t quite understand is why research data on effectiveness for pregnancy and STI risk reduction wasn’t presented or required. The manufacturer is claiming that the new version is essentially equivalent to the female condom already on the market, but the material has been changed from a polyurethane to a nitrile – it seems like a change in what the condom is made of might warrant additional study. The full transcript of the meeting is not yet available, so perhaps this question was addressed, but it’s not apparent that any research was presented suggesting whether the nitrile material is as effective as polyurethane in preventing sexually transmitted infections or pregnancy.
As from the Daily Women’s Health Policy Report notes, the new material makes the condoms less costly and the FC2 is already in use in other countries.
Update: The National Women’s Health Network has released their . In it, they address the FDA’s concerns about the study and recommend approval of the condom, and also ask for further discussion of and research on how spermicide may affect the device.