A bipartisan team of lawmakers is calling on the U.S. Government Accountability Office (GAO) to find out why it took the Food and Drug Administration (FDA) decades to realize that power morcellators pose serious cancer-spreading risks for women undergoing hysterectomies.

The Wall Street Journal is reporting that twelve members of Congress sent a letter demanding an investigation of the FDA’s approval and monitoring of morcellators.

At least 10 power morcellators were approved in the last 24 years. However, it was not until “decades after some studies were already pointing to a serious problem” that the FDA realized the risk of spreading cancer was much higher than expected.

According to the letter reviewed by the WSJ:

“The FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000 . . . How did they get it wrong for so long?”

Power Morcellation Cancer

In the general population, about one in 10,000 women has undiagnosed uterine cancer. However, women who choose to have a hysterectomy are not the general population — they are usually choosing to have a hysterectomy to treat pain, bleeding, large fibroids, or other symptoms that could also be cancer.

For women being treated with a morcellator during a hysterectomy, about 1 in 350 has undiagnosed cancer. Unfortunately, there is no way of knowing whether a fibroid is actually cancer until after the hysterectomy.

In November 2014, the FDA issued a Safety Communication to warn that morcellators should not be used on the “vast majority” of women. However, no recalls were issued and many manufacturers continue to sell the controversial medical devices.

FDA Under Scrutiny for Morcellator Approval Process

For the FDA, medical devices fall into one of three categories: Low-risk products (think tongue depressor) see little regulatory oversight for obvious reasons; High-risk devices, like implantable products, are scrutinized with the same caution reserved for pharmaceutical drugs, including large-scale clinical trials and sometimes years of medical board review.

But power morcellators fall into the middle-ground of moderate-risk devices. Apparently more dangerous than a low risk product, but less dangerous than something implanted inside the body, moderate-risk devices are eligible for the 501(k) clearance process.

501(k) is a sort of “fast track” approval process. If a device manufacturer can demonstrate that its new product operates similarly to a pre-existing device, it can be cleared for market without any need for new safety testing. In other words, manufacturers don’t need to demonstrate the safety of their products, even if they’re being cleared for completely new uses.

However, in April 2014, the U.S. Food & Drug Administration (FDA) warned that morcellators could “significantly worsen . . . the patient’s likelihood of long-term survival.” Last November, the agency required manufacturers to include a black box warning on the labeling of their morcellators, leaving many to wonder how the devices were allowed to be fast-tracked for approval.

Despite these recent events, the FDA is adamant that the 510(k) process is fair and safe.

Dangers and Risks of Power Morcellators

Morcellators are used during minimally-invasive gynecological procedures, such as hysterectomy surgeries and fibroid removal. The device pulverizes tissue so it can be removed through tiny incisions. However, when morcellators are used on women who have undetected uterine sarcoma cancer, they can spread cancerous tissue throughout the abdomen and pelvis.

As the significant dangers of power morcellation gain further attention, public scrutiny has been thrown far and wide.

Under increasing pressure, many insurance companies have opted to limit coverage for procedures involving the dangerous devices. At least one power morcellator manufacturer, Johnson & Johnson’s Ethicon subsidiary, has seen fit to pull its products from the market and many health insurers refusing coverage for power morcellation surgeries.

Individual doctors and hospitals have not escaped criticism either, with several patients filing personal injury lawsuits against both device manufacturers and the surgeons who chose to use power morcellators.