30 July 2014

Power Morcellation: What Every Woman Should Know

I was asked to share the following information with my readers. I pray good health for all of you! ~ Suzanne (PS Annie!)

Statistics show that one in five women will have a hysterectomy over the course of their lifetime. This surgery is commonly performed to remove fibroids. These are benign tumors of muscular and fibrous tissue that typically develop in the uterine wall. Such fibroids can be a source of heavy bleeding and pain. In the U.S., approximately 396,000 hysterectomies are performed each year for the treatment of fibroids.

In April 2014, the U.S. Food and Drug Administration (FDA) issued a warning that power morcellation used in hysterectomies can potentially cause the spread of cancer. A power morcellator is a surgical instrument with sharp blades that minces or "morcellates" tissues for extraction from the abdomen. On April 17, the FDA published its findings after studying the prevalence of unsuspected cancer in women undergoing uterine or fibroid removal.

Based on this study, the FDA concluded that 1 in 350 women who undergo these surgeries has an undiagnosed form of cancer called a "uterine sarcoma." The risk with power morcellation is that the fragmented tumor can spread to a woman's pelvis and abdomen. The horrific consequences of metastasis can leave a woman with only 2-3 years left to live.

Unfortunately, there is no reliable preoperative means to determine whether a woman with fibroids has a uterine sarcoma. The presence of one type of especially aggressive uterine sarcoma, termed a "leiomyosarcoma," further worsens an already bleak prognosis. A leiomyosarcoma (LMS) can develop in approximately 1 in 498 women with fibroids.

The FDA has strongly advised against the use of power morcellation during hysterectomy and fibroid removal. It has also mandated that manufacturers of the power morcellator further research the risks involved in its use. The agency has stipulated that product labeling must display accurate risk information.

On July 10 and 11, the FDA held a public meeting with the country's foremost obstetricians and gynecologists to discuss the dangers of power morcellation. Members of the Obstetrics & Gynecology Devices Panel were divided regarding risks versus benefits of power morcellators. A decision is pending on whether to restrict or ban their use.

For more information about this device, it's dangers, and how the FDA and manufacturers are handling this, visit the American Recall Center. Campaigning against these hazardous devices will save the lives of hundreds of at-risk women. Let's do everything possible to publicize this critical information.

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