In a previous article regarding power morcellators, we reported that the Government Accountability Office was urged by Congress to launch an investigation into the dangers of the power morcellator. It looks like the GAO has listened to the letter written by 12 members of Congress, requesting an investigation.
Katherine Siggerud, managing director for congressional relations at the GAO, told The Wall Street Journal, “We’ve agreed to do the work.” Last month, a bipartisan group of 12 lawmakers including Rep. Mike Fitzpatrick and Rep. Louise Slaughter sent a letter to the GAO inquiring the company to look into the FDA’s morcellator regulation. The FDA has cleared at least 10 power morcellators for sale since the first launched close to 24 years ago.
In the letter to the GAO, lawmakers write:
“Hundreds, if not thousands, of women in America are dead because of a medical device known as a laparoscopic power morcellator. This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. For too many women, this routine procedure ended with a death sentence.”
Although the FDA has flagged power morcellators’ risk of spreading undetected cancer, its warning came nearly decades after studies were already revealing a serious issue. The GAO has not revealed details about the probe, and it’s too soon to tell how long the investigation will take. The FDA will cooperate with any GAO review, but does not comment on pending or ongoing investigations.
This investigation lights a fire under the FDA, which is facing a good deal of scrutiny over these morcellator devices. Last year, the FDA issed a warning against the power morcellator in minimally invasive surgeries to remove uterine fibroids, claiming there was a one in 350 risk of uterine sarcoma in women. Before they issued this warning, the morcellator was used in around 50,000 U.S. uterine surgeries a year.
The GAO has come into the ring due to a FBI probe in May. The FBI is reportedly attempting to establish whether Johnson & Johnson, one of the biggest manufacturers of power morcellators, knew as early as nine years ago that the device can spread uterine cancer.
What questions did lawmakers ask the GAO about power morcellators?
The legislators asked the GAO to consider four questions:
- Did the FDA’s reliance on the 510(k) approval policies and procedures sufficiently identify risks of adverse events before the laparoscopic power morcellator was allowed to enter the market?
- Were the medical device reporting regulations (21 CFR 803) appropriately followed to protect patient safety in the case of the laparoscopic power morcellator by manufacturers, importers, user facilities, and the FDA?
- What activities or training did manufacturers provide to clinicians and what professional society standards, if any, apply to training on the use of these devices?
- What steps is the FDA taking after issuing the black box warning to further determine whether the laparoscopic power morcellator is safe to remain on the market?
The investigation is thought to begin in about five months, and the full letter to the GAO can be found here. However, the FDA stands by their regulation, claiming that the 510(k) clearance allows it to balance “innovation and safety.” The agency has not banned power morcellators altogether, saying that the devices’ benefits outweigh the risks in some women.
If you or someone you love has had a power morcellator procedure and has developed cancer, we can help you file a lawsuit and hold the manufacturer accountable.
Contact us today at 1-800-214-1010.
Sources: Fierce Pharma, Cancer Letter
