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Power Morcellation Dangers Drive Healthcare Bill Amendment

scales of justice and gavelAn amendment proposed by Representative Mike Fitzpatrick (R-PA.) was added to the 21st Century Cures Act before it passed the House. The bill would implement many healthcare reforms and has been widely touted, given its bipartisan support. However, some experts, including leading consumer advocacy group Public Citizen, have been staunchly opposed to the bill, despite a new provision from Rep. Fitzpatrick.

The new amendment was added to the bill over concerns of life-threatening power morcellator side effects, such as the potential to cause the spread of cancer cells during routine gynecologic surgeries.

Amendment intended to improve tracking

In 2013, the FDA began requiring unique device identifiers on medical device labels. The agency expected it to take several years to phase in the new requirement. Rep. Fitzpatrick’s amendment would take this a step further by requiring that unique device identifiers be included in affected patients’ electronic health records (EHRs). This would allow for precise tracking of adverse events and may presumably improve patient safety. Rep. Fitzpatrick’s office released a statement noting that his amendment “adds pressure” to the FDA’s tracking requirements.

Rep. Fitzpatrick and other legislators introduced other amendments as well; however, they were struck down by the House Rules Committee. One of his amendments would have struck down the highly controversial Sections 2221 and 2222, which propose to allow companies to make changes to medical devices – including high-risk devices – without notifying the FDA first and without documenting the safety profile. As written, the bill also would allow the FDA to approve these devices based on inconclusive evidence from medical anecdotes and medical journals, which may theoretically lack a control group and a large group of study participants.

Potential risk of defective medical devices

The push to include unique device identifying information in patients’ EHRs was fueled by recent headlines regarding power morcellators and their link to cancer metastasis. Surgeons may use power morcellators when performing laparoscopic hysterectomies or myomectomies. Myomectomy refers to the removal of uterine fibroids and hysterectomy refers to the removal of the uterus, and possibly other reproductive organs such as the fallopian tubes, ovaries, and cervix. When surgeons use a minimally invasive approach to perform these surgeries, the structures must be rendered into small pieces before the surgeons can remove them from the patient. Power morcellators are tools that accomplish this.

However, in breaking up bodily structures, power morcellators also have the potential to spread in situ cancer cells well beyond their point of origin, effectively turning a stage one diagnosis into a stage four diagnosis. This is a matter of concern because some women undergoing hysterectomies and myomectomies are unaware that they have cancer before having these surgeries.

Some lawsuits alleging uterine cancer after morcellation have been filed, claiming that the manufacturers should be held liable. The FDA issued a black box warning for these devices after reports of morcellator risks arose. Johnson & Johnson pulled its power morcellators from the market. Although other brands are still available, many hospitals have restricted or eliminated their use.

If the bill is signed into law, the Fitzpatrick amendment would facilitate precise tracking of many other high-risk medical devices, in addition to power morcellators. Some examples of high-risk, or class III, medical devices include replacement heart valves, implanted cerebella stimulators, and implanted pacemakers.