Product News and Recalls

FDA Not Doing Enough to Protect Women

report says FDA not doing enough to protect women from faulty medical devicesA study conducted by researchers at Northwestern University has concluded that the FDA has largely failed in its responsibility of protecting women from faulty or poorly designed medical devices.

Of the 18 devices approved between 2000 and 2015 for high risk application to women’s medical care; including fetal monitoring, contraception, and uterine bleeding:

  • Four failed to demonstrate that they were actually effective,
  • Six continued to remain on the market with no further safety studies, and
  • Three were completely withdrawn from the market.

That is an abysmal record for a federal agency tasked with ensuring the public’s safety and many people are wondering what, exactly, the FDA is doing to ensure that women’s safety is taken seriously. After all, news surrounding the agency at this point speaks more to its dysfunction than its successes. The scrutiny that devices receive prior to approval seems to be a matter of money and random chance, and when a bad one slips through the cracks, the damage can be severe.

Essure, a contraceptive device designed to trigger scar tissue production to block a woman’s fallopian tubes, has been found to migrate, break, and even to perforate other organs. Transvaginal mesh devices have been found to do much of the same once in place. And power morcellators – devices that were approved with less scrutiny than other medical devices – have been found to potentially spread undiagnosed uterine cancer cells throughout a woman’s abdomen, contributing to a significant upstaging of her cancer diagnosis.

What is perhaps most infuriating, however, is that lives are being drastically affected; and even lost, in the name of accelerated innovation and, tangentially, accelerated profits. One of the researchers and authors of the study, Dr. Steve Xu, says that “device regulation is just so much weaker than drug regulation, and it doesn’t make any sense. The argument is that more rigorous regulation would decrease innovation. But I would say that has not been demonstrated.”

The FDA has refused to comment on the Northwestern study.

The release of the study comes at a delicate time for the FDA, as the 21st Century Cures Act makes its way through the House and Senate. Passage of the bill would weaken the influence of the scientific community even further, as a main goal of the bill is to broaden the definition of “valid scientific evidence.”

As an agency whose very task is dependent on the best research being done by the best researchers in the world, one has to wonder if the FDA will come to science’s aid, or if passage of the bill will come as just another agency failure.