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Study Says FDA Needs to Establish Stronger Device Rules to Protect Women

Kaitlynn Martin5 months ago

According to an analysis by Northwestern University, the Food and Drug Administration (FDA) has been approving numerous high-risk women’s health devices over the course of 15 years. These approvals were based on weak clinical studies that sometimes showed no effectiveness.

Overview of the Analysis

With help from the FDA database, researchers looked at all 18 high-risk devices that have been approved between 2000 and 2015. Of these 18, four devices were not proven effective, six were not required to conduct postmarketing safety studies, and three have even been removed from the market due to safety concerns.

The FDA has a history for having relatively lax approval standards for medical devices. This research focused more on high-risk obstetrical and gynecological devices.

FDA rules state that devices posing the highest potential risk to patients must submit enough clinical data to show its safety and effectiveness. Even with this pathway, the FDA still does not require that the clinical data come from randomized trials, which are typically the gold standard in research. The data also does not have to be evaluated by an advisory committee.

According to Northwestern physician and health-policy researcher Steve Xu, device regulation is just so much weaker than drug regulation, and that does not make sense to him. An FDA representative responded saying they do not comment on individual studies.

Findings of the Analysis

  • Intergrel: Aimed to prevent postoperative internal scarring called adhesions, and failed to do that in clinical testing. Yanked from the market in 2003 after negative reactions.
  • Oxifirst: Fetal oxygen saturation monitor, which failed in its stated claim that is reduces cesarean deliveries. This device as well as another similar one, was not required to show any clinical benefit.
  • LUMA Cervical Imaging Device: This was intended to enhance existing technology for biopsying cervical tissue containing precancerous or cancerous cells. The device has increased “false positives.”


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