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Pennsylvania Congressman Introduces Two Bills Aimed at Better Medical Device Regulation

Oct 7, 2016

U.S. Representative Mike Fitzpatrick, long a crusader for better regulation of medical devices, is taking his concerns to his peers in Congress.

Rep. Fitzpatrick has asked the Committee on Energy and Commerce to hold hearings on updating laws governing medical devices, Consumer Advocacy News reports.

Fitzpatrick has drafted and introduced two bills into Congress that would change how defective medical devices are reported and would help injured patients hold manufacturers responsible for defective devices.

The first bill, the Medical Device Guardian's Act, would require doctors to report any adverse events involving medical devices. Under the current system, hospitals must report adverse events involving medical devices, but reporting by doctors is voluntary. This complicates the task of identifying defective devices.

The inspiration for this legislation was the long delay in achieving public acknowledgement of the risks associated with the power morcellator, a surgical tool used in hysterectomies and uterine fibroid surgery. The device allows minimally invasive surgery but it can spread undetected cancer through a woman's abdomen. The power morcellator, however, was on the market for nearly 20 years before the risk was acknowledged in a label warning. Hundreds of patients say they were not adequately warned of the risks before they had a morcellator procedure. Once the cancer has spread, a woman's long-term survival chances are greatly reduced. The Medical Device Guardian's Act would reduce the amount of time required to identify dangerous devices.

The second piece of legislation-Ariel Grace's Law-was inspired by Bayer A.G.'s Essure birth control device. The bill was named for a child who died in utero due to complications in the pregnancy caused by Essure. Essure is a non-surgical permanent form of birth control but some women can become pregnant with the device in place, and the fetus can be injured or the woman can suffer a miscarriage.

Essure is the first device of its kind and was intended to be a simple solution for permanent birth control without surgery. But since Essure came to market, thousands of women have reported serious side effects. The women say Bayer downplayed the true safety risks of Essure. In February 2016, after a hearing of the Obstetrics and Gynecology Devices Panel, the FDA directed Bayer to add a black box warning to Essure's labeling to advise patients and doctors that Essure could cause serious injury or death. The agency shopped short of pulling Essure from the market, though patients and their advocates had requested such action.

Ariel Grace's Law would take Essure off the market and would also eliminate a federal preemption law that has protected Bayer from liability in a number of Essure lawsuits.

Action on Fitzpatrick's bills will likely take some time, according to Consumer Advocacy News. Medical devices are prolife and delivery of rating, with implantable and external devices providing life support and delivery of critical medications. Device regulation is highly contested. For their part, doctors are concerned about being held liable for device problems that are the manufacturer's responsibility. But Rep. Fitzpatrick is determined in his efforts to make devices safer, and hold manufacturers to stricter safety standards.

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