During his four terms in office, U.S. Rep. Mike Fitzpatrick has focused on policy issues like national security and taxes. But in recent years he’s become a champion for women’s health.
Fitzpatrick’s focus changed in 2014, when was approached during a Christmas parade by cardiac surgeon Hooman Noorchashm and his wife, anesthesiologist Amy Reed. During their hour-long chat, Noorchashm and Reed told Fitzpatrick a disturbing tale about a medical device used to perform hysterectomies and uterine fibroid removals that had been linked to the spread of an aggressive form of uterine cancer. The couple was became aware of the problem after Reed was diagnosed with uterine sarcoma following a hysterectomy in which the now-controversial device – a power morcellator – was used.
Power morcellators are fitted with a tube-like blade that shreds uterine growths or entire uteruses inside the body and removes the bits of tissue through a small incision in the abdomen. The procedure was favored over open surgery because it offered shorter recovery and less scarring.
However, researchers have found that women with previously undetected uterine cancer were at greater risk for cancer spread after undergoing power morcellation, which made the disease more difficult to treat and worsened their odds of survival. Some uterine cancers, such as aggressive uterine sarcoma, are difficult to detect and diagnose prior to surgery.
Fitzpatrick quickly became a leading voice in Congress about medical device safety and pressed the FDA to explain why it waited so long before warning doctors and patients of the cancer spread risk with power morcellation. The device now carries a black box warning.
Last year, Fitzpatrick took aim at another medical device that has caused injuries to women – Bayer Healthcare’s Essure permanent birth control method. The implants were linked to complications such as migration and perforation of the fallopian tubes and uterus, as well as allergic reactions, chronic pain and infections. After more than 5,000 complaints, and pressure from Fitzpatrick, the FDA conducted a safety review of the Essure birth control device. Late last month, the agency recommended a black box warning be placed on Essure.
Fitzpatrick says he will not run for another term, but he will continue to support more oversight with medical devices. “The issue is once the FDA has approved it and it is out there and you have found people who have been harmed, what is your process for dealing with that?” Fitzpatrick told Philly.com. “They are excruciatingly slow and ineffective in withdrawing something from the market.”