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Power Morcellator Concerns Prompt Medical Device Safety Measure

Concerns over the cancer risk created by power morcellation have spurred a new medical device safety measure in Congress. The House of Representative recently approved legislation that would require medical device identifiers to be included in patients’ electronic health records.

The proposal is part of the larger 21st Century Cures bill, which alters how the U.S. Food and Drug Administration (FDA) approves some drugs and increases funding for medical research. The medical device proposal was sponsored by Rep. Mike Fitzpatrick, (R., Pa.), who is a cancer survivor.

As detailed by the Wall Street Journal, Rep. Fitzpatrick acknowledged that he was prompted to introduce the measure in the wake of the controversy surrounding the use of power morcellators, and he hopes it sparks a larger debate about how medical devices are regulated and tracked. “What happened with the power morcellator should never be allowed to happen again,” Rep. Fitzpatrick stated at a hearing of the House Rules Committee.

As we have previously discussed on this San Diego Injury Blog, laparoscopic power morcellators are inserted into the abdomen during hysterectomies and fibroid removal procedures and used to cut up tissue in order to remove it through a small incision. While the medical devices allow doctors to perform a less invasive procedure, they can unknowingly spread cancer cells throughout the body.

According to statistics compiled by the U.S. Food and Drug Administration (FDA), approximately 1 in 350 women who undergo a hysterectomy or fibroid removal surgery are found to have an unsuspected uterine sarcoma. If laparoscopic power morcellation is performed in these patients, the cancerous tissue is often spread within the body and can significantly decrease the odds of long-term cancer survival.

Given the risks, the FDA recommends that device manufacturers include a boxed warning — the strongest warning possible — in their product safety statements and advises that the medical devices should not be used in most women.

If the 21st Century Cures bill is also approved by the Senate, healthcare providers would be required to include the make or model number of any devices used in treatment. The goal of incorporating the information in electronic health records is to more accurately detect and track patient harm.

If you or someone you love has been seriously injured by a dangerous or defective medical device, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.