Do The Menstrual Cups Cause Endometriosis?

Background Information:
Currently there are five Menstrual Cups on the market in the US, Canada, Great Britain, and the European Union (see sidebar). All are designed to be kept in place during menstruation to retain menstrual discharge until it can be conveniently disposed of. Some women are choosing these products for use instead of tampons or menstrual pads. We are concerned that the Menstrual Cups may increase the risk of Endometriosis. This possible health risk is not mentioned on any of the packaging for these products.

Our work on this issue:
Collaborating with the Endometriosis Reseach Center, APT submitted a Citizen's Petition to the US Food and Drug Administration regarding the safety of the Menstrual Cups. In the Petition
(click here to read the Petition),
we explained in detail our concern that the retention of menstrual debris by these products may increase the backflow of mentrual fluid into the peritoneum and increase the risk of a woman developing Endometriosis.
(click here for more information on Endometriosis)


The
Food & Drug Administration replied
(click here to read the FDA Reply)
to the APT/ERC* Petition on the Menstrual Cups
,
and noted the reasonableness of our concern about an increased risk of Endometriosis among Cup users, but they concluded they were unable to act on the Petition, because clinical data demonstrating a link between the use of the Menstrual Cups and Endometriosis was not available:



The FDA did not explain their failure to require manufacturers to warn Cup users about this risk of Endometriosis.

Additional Developments:
July 2005: This organization and the ERC wrote directly to each of the four manufacturers of Menstrual Cups. Using reference to the FDA's "physiologically plausible" comment, we pointed out that the absence of information on endometriosis in their package inserts puts them at risk of liability for a "failure to warn" users about a reasonable health risk.
We hope that this approach will bring a prompt improvement in the warnings that come with each Menstrual Cup.
(Click here to review that correspondence.)

August 2005: A representative of the Canadian manufacturers of The Diva Cup contacted us to discuss our concerns. They already have information on Endometriosis on their web site, and seem to be considering additions to their package information.

April 2006: In response to an inquiry from the Mooncup manufacturers regarding the results of the ERC questionnaire on endometriosis and menstrual cup use, we distributed a Summary Statement of Results and A Call for Additional Research to each of the Cup manufacturers.

To read the APT/ERC* Apr. 2003
Petition on the Menstrual Cups,
Click Here


To read the FDA's
Reply to the Menstrual Cup Petition,
Click here


*The Endometriosis Research Center (ERC) (http://www.endocenter.org)
co-sponsored the Cup Petition.

The commercially available
Menstrual Cups

The FDA does not recognize subgroups in these products, but there are two distinct designs -

Instead is a diaphragm-like device that is worn directly over the cervix
The Keeper, Diva Cup , The Mooncup and Lunette are flexible cups that sit in the vagina, leaving a space between the product and the cervix.

There is no literature to suggest that either design is more or less likely to induce the reflux of menstrual debris into the peritoneum.
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