Representative Mike Fitzpatrick, who has been calling for stricter medical device regulations, has asked the Committee on Energy and Commerce to hold a medical device hearing in order to update laws. This is not the first time Fitzpatrick has taken action in pursuit of tougher medical device regulations. He recently helped draft and introduce two bills that aim to change how medical device injuries are reported.
Fitzpatrick introduced the Medical Device Guardians Act, a law that would require physicians to report medical devices injuries. Current regulations already require them to report adverse events with drugs, but the law only orders hospitals and manufacturers to report medical device issues. The proposed regulation would also protect doctors from civil liability, meaning that material in the reports cannot be used against them.
The Medical Device Guardians Act was launched in light of delayed safety risks surrounding power morcellators, devices used to cut up tissue into smaller pieces during laparoscopic gynecologic procedures. These tools are often used during a minimally invasive hysterectomy or myomectomy, removal of uterine fibroids. The problem is that sometimes, a presumed fibroid is actually an undetected uterine cancer that cannot be reliably detected before surgery. Using a power morcellator on cancerous tissue can spray malignant cells throughout the pelvic cavity and greatly worsen, or “upstage” the cancer.
Power morcellator risks were brought to light by husband-and-wife physicians who experienced the issue personally. At the time Dr. Amy Reed underwent a hysterectomy with a power morcellator, it was believed that the chances of a hidden uterine cancer masquerading as a fibroid were very rare. After a review of literature however, it was discovered that 1 in 350 women undergoing these procedures are at risk. The U.S. Food and Drug Administration (FDA) issued a safety alert in 2014 and placed a black box warning on morcellators.
Mike Fitzpatrick and fellow representative Louise Slaughter introduced the bill in light of these issues. They say it should not have fallen on patients to bring these problems to the public sphere.
Fitzpatrick also introduced Ariel Grace’s Law, which was prompted by Bayer’s Essure permanent birth control device. The legislation seeks to take Essure off the market and hold Bayer liable for alleged complications. Essure is composed of two metal springs inserted into the fallopian tubes to block fertilization. Women have complained of abdominal pain, menstrual irregularity, headaches, fatigue and pregnancy despite implantation.
