ENDOMETRIOSIS RISK FROM USE OF MENSTRUAL CUPS DRAWS FDA PETITION

Public interest health groups call on FDA to stop sale of menstrual cups due to potential increased risk of the painful disease, Endometriosis.

DELRAY BEACH, FL. (PRWEB) April 24, 2003 -- Two public interest health groups have called on the US Food and Drug Administration (FDA) to stop the sale of menstrual cups (The Keeper®[www.keeper.com] and Instead® www.Softcup.com]). Associated Pharmacologists & Toxicologists (APT) and the Endometriosis Research Center (ERC) have submitted their Petition to the FDA, in which they cite research to demonstrate that blocking the release of menstrual debris, inherent to the use of menstrual cups, is likely to increase the incidence and severity of endometriosis. They also called for the FDA to inform current users of these products of their increased risk of endometriosis, as this information is not currently included with the menstrual cups.

An estimated 7 million women in the US suffer from Endometriosis, with millions more worldwide. The definitive cause of the disease remains unknown, though it is believed to be multi-factorial in origin, including genetics, immunology and exposure to environmental toxicants, such as dioxin. However, a large number of clinical reports and animal studies have demonstrated that the retention of menstrual discharge promotes the backflow of cells that normally grow in the uterus and initiates their growth in the gut cavity, contributing to the development of the disease in some women.

Endometriosis can involve intense pain, requiring drug and surgical treatments, and is a leading cause of infertility among women. There is no absolute cure for the disease.

The Keeper®, one of the two menstrual cups currently sold in the US, is a flexible rubber cone that sits intravaginally to occlude menstrual discharge. Instead® is a plastic, diaphragm-shaped disc that covers the mouth of the uterus with an impermeable barrier. The Keeper® is a reusable menstrual cup; Instead® is intended for one time use and disposal. Both products carry recommendations to be left in place for up to 12 hours to block the release of menstrual debris.

The ERC [www.endocenter.org] is concerned that women and adolescents will look to these products as safe alternatives to tampons and menstrual pads, given the recent rise in dioxin concerns, without knowing the full potential dangers. Heather C. Guidone, Director of Operations for the ERC said, "we owe it to women and teens - with and without endometriosis - to be vigilant in our investigations of all potential contributors to this insidious disease."

Armand Lione, Ph.D., President of Associated Pharmacologists & Toxicologists, Washington, DC, added: "Women who use these products as an alternative to tampons need to be warned that endometriosis is a real risk associated with the menstrual obstruction caused by the menstrual cups."

The ERC is currently conducting a study on the experiences of women and teens with endometriosis that use, or may have used, menstrual cup products.

CONTACT:
Armand Lione, Ph.D.
President, APT
202/544-0711
ArmandLione@hotmail.com

Heather C. Guidone
Director of Operations, ERC
800/239-7280
EndoFL3@aol.com