Rep. Mike Fitzpatrick Calls for Stricter Medical Device Regulations

Rep. Fitzpatrick Calls for Stricter Med. Device Regulations
Rep. Fitzpatrick Calls for Stricter Med. Device Regulations

In an effort to push for stronger medical device regulations, Representative Mike Fitzpatrick has called on the Committee on Energy and Commerce to hold a medical device hearing. The goal of the hearing would be to update laws governing medical devices, ultimately in the hopes of making things safer for patients.

Fitzpatrick has also been active in other areas regarding patient safety. He recently helped draft and introduce two bills regarding medical devices. One of them is the Medical Device Guardians Act, which was prompted by the delayed awareness surrounding the safety of power morcellators. Power morcellators are used in minimally invasive gynecologic procedures, but in the past few years it has become clear that they can spread a hidden uterine cancer. These dangers were brought to light by husband-and-wife physicians who dealt with the issue themselves, and made it their mission to raise awareness. Research had shown for years that morcellators could worsen an undetected cancer, but this information was not well-known until recently.

The U.S. Food and Drug Administration (FDA) placed a black box warning on power morcellators in 2014, warning that 1 in 350 women have an undetected uterine cancer that can be worsened through morcellation. Mike Fitzpatrick and fellow representative Louise Slaughter introduced the bill in light of morcellator risks.

Additionally, Fitzpatrick introduced Ariel Grace’s Law. This proposed legislation was also prompted by the safety of a medical device: Bayer’s Essure. Essure was marketed as a non-surgical option for women who no longer want to have children. The device consists of two metal springs that are inserted into the fallopian tubes. The idea is that as scar tissue grows around the coils, sperm is blocked from the egg, preventing fertilization. However, some women have reported getting pregnant despite the procedure and suffering miscarriages. There have also been reports of abdominal pain, menstrual irregularity, headaches, fatigue and other complications. Ariel Grace’s Law would make it easier for patients to sue over Essure and get the device off the market.