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New Device Approval

Microwave Endometrial Ablation (MEA) System – P020031

MEA Applicator	MEA System

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Microwave Endometrial Ablation (MEA) System
Manufacturer: Microsulis Medical Limited
Address: Microsulis House, Parklands Business Park, Denmead Hampshire, PO7 6XP England
Approval Date: September 23, 2003
Approval Letter: http://www.fda.gov/cdrh/pdf2/p020031a.pdf

What is it? Endometrial ablation is a minimally invasive surgery that can be a viable alternative to hysterectomy. The MEA System uses microwave energy to destroy the endometrium and may minimize or even stop excessive uterine bleeding, also called menorrhagia.

The MEA System is a surgical device that uses microwave energy to treat excessive menstrual bleeding by destroying tissue lining the uterus (womb). A long slender tube that delivers microwave energy is inserted into the uterus to destroy tissue. Treatment typically lasts 3 ½ minutes and should be painless.

How does it work? After the patient receives appropriate anesthesia, the applicator is inserted through the vagina into the uterus. A computer is used to deliver microwave energy which causes a rise in temperature where the tip of the applicator meets the tissue. The surgeon moves the applicator in a sweeping motion from side to side across the tissue while slowly pulling the applicator out of the uterus. This “painting” of the inside of the uterus with the applicator destroys the endometrium. The endometrium is a fluffy layer of tissue lining the uterus that passes out of the body with the blood when women menstruate (monthly period).

When is it used? This device is intended for pre-menopausal (pre-change-of-life) women whose child-bearing is completed and who have a condition called menorrhagia, in which there is excessive uterine bleeding. The device is used only in women whose menorrhagia is due to non-cancerous causes.

What will it accomplish? The MEA System was shown to successfully reduce menstrual bleeding to normal levels one year after treatment in approximately 87% of women in a clinical study. In approximately 55% of women, menstrual bleeding was totally stopped.

The most common side effects of this treatment include:

• cramping of the uterus similar to menstrual cramps,
• nausea, and
• vomiting.

When should it not be used? This device should not be used in a patient who:

• has undergone any previous endometrial ablation procedure,
• has had the MEA applicator re-inserted following treatment or partial treatment,
• is pregnant,
• wants to become pregnant in the future,
• has had a classical cesarean section childbirth, transmural myomectomy or any other anatomic or pathologic condition in which weakness of the myometrium could exist,
• has an intrauterine device (IUD) currently in place,
• has Essure contraceptive micro-inserts,
• has undiagnosed vaginal bleeding,
• has a myometrial thickness of less than 10 mm in any area of the uterus,
• has a uterine sounding length less than 6 cm,
• has uterine perforation or wall damage observed or suspected during pre-procedure examination,
• has pre-malignant conditions of the endometrium, such as unresolved (atypical) adenomatous hyperplasia (non-cancerous excessive tissue growth),
• has a known or suspected endometrial carcinoma (uterine cancer),
• has undergone mechanical endometrial thinning such as dilation and curettage (D&C) or suction aspiration,
• has an active genital or urinary tract infection at the time of the procedure, or
• has active pelvic inflammatory disease (PID).

Microwave Endometrial Ablation is not a sterilization procedure.

Reducing Patient Risk

FDA has reviewed 27 reports of rare serious injuries that occurred in MEA procedures performed outside the U.S. In these cases, patients experienced burns through their uterus and intestines that required abdominal surgery to remove damaged tissue and repair the intestines.

To reduce the risk of injury, surgeons performing MEA procedures must now:

• perform an ultrasound evaluation to ensure that a patient’s uterine wall is thick enough for the MEA procedure,
• conduct a visual inspection of the inside of the uterus (hysteroscopy) just before the procedure to ensure the uterine wall is undamaged,
• participate in a special training program emphasizing the pre operative procedures, and
• conduct at least three supervised MEA procedures before they perform unsupervised.

These procedures were introduced during the U.S. clinical trial, and no injury of this type was observed. However, the number of patients in the clinical trial who underwent the MEA procedure was not large enough to conclude that these additional requirements eliminate the risk of injury.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf2/p020031.html

Other:

• FDA Consumer article: “Alternatives to Hysterectomy: New Technologies, More Options”
  www.fda.gov/fdac/features/2001/601_tech.html
• Information on Dysfunctional Uterine Bleeding (DUB) with illustration
  http://www.nlm.nih.gov/medlineplus/ency/article/000903.htm

January 21, 2004

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