The U.S. House of Representatives recently passed a wide-ranging medical research bill that includes a provision designed to improve the safety monitoring of medical devices. Rep. Mike Fitzpatrick (R., Pa.) proposed the amendment, saying he was motivated by the laparoscopic power morcellator, a controversial medical device that allegedly causes the spread of a rare and deadly cancer.
21st Century Cures Act
The amendment is part of the 21st Century Cures Act, a measure aimed at, among other things, increasing federal funding for medical research and changing the drug approval process in the U.S. The Fitzpatrick provision would require electronic health records to include unique device identifiers, such as the make or model number of the devices used in treatment, to allow for closer monitoring of patient injury.
What are Power Morcellators?
Morcellators are medical devices that are used in thousands of laparoscopic hysterectomy and myomectomy procedures each year. They allow surgeons to perform these surgeries in a more minimally invasive manner by chopping up the uterine tissue or fibroids and removing the matter through a small abdominal incision, minimizing scarring and reducing recovery time.
However, there is no definitive way to diagnose uterine cancer before using morcellator devices, so when the tissue is ground up, undetected leiomyosarcoma, endometrial stromal sarcoma, and other types of deadly cancer cells can be spread throughout the abdomen, leading to rapid spread and upstaging of the disease.
Unique Device Identifiers Recommended by FDA
In 2014, the U.S. Food and Drug Administration (FDA) issued a guidance document recommending that labels of medical devices include unique device identifiers, and planned to phase the system in over the next several years.
These identifiers are not currently incorporated into all electronic health records, but supporters of the current Amendment said the provision would likely help hasten the process. The chairman of the Senate health and education committee, Sen. Lamar Alexander (R., Tenn.), has said that he intends to get a measure through his panel by the end of 2015 and onto the Senate floor in 2016.
The buzz about the risks associated with morcellators has led politicians to call for an outright ban on the devices. An online petition supporting a ban has gained more than 88,700 signatures.
If you or a loved one has suffered from cancer spread by a power morcellator during surgery, you need to make sure you know your options. You may be entitled to compensation from the company that manufactured the device that caused this horrible ordeal.
Contact the attorneys at Childers, Schlueter & Smith today. Consultations are free and without obligation.
Other Morcellator News
A recent study links the FDA’s morcellation warning to increased invasive surgeries for uterine fibroids, raising concerns about reduced access to minimally invasive treatment options for women.
Olympus America is redesigning its power morcellator with a containment system, but the FDA remains concerned about cancer risks. Legal and safety questions persist amid ongoing clinical trials and lawsuits.
The GAO report finds the FDA underestimated cancer risks from power morcellators, highlighting gaps in postmarket device monitoring and raising concerns for patients undergoing fibroid surgeries.
Johnson & Johnson has settled nearly 70 lawsuits over its laparoscopic power morcellator, with cases citing risks of spreading undetected cancer. Additional claims remain pending in multidistrict and state court litigation.
Federal courts have consolidated morcellator cancer lawsuits against Johnson & Johnson and Ethicon, streamlining pretrial proceedings for women alleging the device spread undetected cancer during surgery.
The U.S. Government Accountability Office will investigate whether FDA approval and oversight failures allowed dangerous power morcellators to remain on the market despite their potential to spread hidden cancers.
