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Morcellation | FDA Guidelines

From the Pre-Op Hysterectomy Articles List

What is the latest information about morcellation and hysterectomy?What is the latest information about morcellation and hysterectomy?

In a safety communication issued on November 24, 2014, the FDA did not ban the use of power morcellators. Instead, the FDA indicated that they believe the risk of women with fibroids having an undetected uterine sarcoma is higher than previously thought, so most women should not undergo morcellation for the treatment of uterine fibroids. They further stated that two groups of women should not undergo morcellation. These are perimenopausal and post-menopausal women with fibroids, and women who have known or suspected gynecologic cancer (a).

Also on November 24th, the American College of Obstetrics and Gynecologists (ACOG) issued a statement regarding power morcellation. The ACOG was pleased that the FDA clarified the contraindications for morcellation; however, they believe some additional clarification is needed to be sure patients and physicians are fully informed. As advocates for patient safety, the ACOG believes that current and future clarifications will allow low risk women to benefit from this procedure while protecting high risk women from a negative outcome.

According to the ACOG, power morcellation plays an important role in gynecologic surgery for women who are at low risk for malignancy. For these women, morcellation can allow for minimally invasive surgery options which can offer significant benefits including decreased bleeding, less pain, quicker healing, shorter recovery, less trauma, and fewer scars (b).

The American Association of Gynecologic Laparoscopists (AAGL) states that they support the FDA’s recommendation for a black box warning as it will enhance informed consent. However, they agree with the ACOG that additional clarification is needed as the FDA’s current statement can be confusing for both physicians and patients.

The AAGL stands by data that indicates the risks of uterine sarcoma, specifically uterine leiomyosarcoma, is much lower than the 1 in 352 rate being used by the FDA. At their recent conference, information was shared to explain the discrepancy in numbers, including how each of the following affects the data: the type of facility; age and symptoms of patient; whether studies have been published and peer reviewed; and re-evaluation.

The AAGL is committed to “serving women globally by advancing the safest and most efficacious diagnostic and therapeutic techniques that afford less invasive treatments for gynecologic conditions,” and this includes offering morcellation to women for whom it is appropriate (c).

It is important that all women facing a hysterectomy or myomectomy work with their surgeon as well as seek a second opinion to determine which surgery is right for their situation. Each woman must weigh her own pros and cons according to her own diagnosis and overall health situation when choosing which hysterectomy type and techniques are right for her. Women should also consider alternative treatment options whenever possible if they will minimize overall risks and side effects.

(a) UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication (November 24, 2014)
(b) ACOG Statement on Power Morcellation (November 24, 2014)
(c) MEMBER UPDATE #5: AAGL Response to FDA Guidance on Use of Power Morcellation during Tissue Extraction for Uterine Fibroids

This content was written by staff of HysterSisters.com by non-medical professionals based on discussions, resources and input from other patients for the purpose of patient-to-patient support.

12-13-2014 - 08:02 PM


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