Will New FDA “Safety Communications” Help Prevent Future Power Morcellator Injuries?
It’s not every day that you find out the Food and Drug Administration (FDA) may be making major, potentially life-saving decisions for the medical and patient community, but that day is here.
We’ve recently learned that the FDA may change the way — and how fast — they alert the medical community and patients around the country to “new safety communications” (FDA-speak for public warnings or reports).
This potential change in procedure may be due to the overwhelming amount of complaints involving the dangerous and potentially cancer-spreading medical devices called power morcellators, devices we are taking on in our power morcellator lawsuits.
For many years, the FDA has issued safety communications after reviewing potentially years-worth of “adverse events” reports that are self-reported by doctors, patients and other members of the medical community like hospitals. These adverse events reports may include reports of medical complications and deaths. However, it has been estimated that a significant proportion of real-world adverse events are never reported to the FDA, and the events that are actually reported to the FDA typically take months for the FDA to review.
What that means is, for patients whose lives were put at risk by dangerous medical drugs and devices, valuable time that could have saved a life was wasted. For some medical devices or drugs, perhaps this review time is really necessary for the FDA to review and validate the risks reported in the adverse event reports. However, for those medical devices and drugs where the risk of harm is especially severe or life threatening, the process is too slow and takes too long.
Thankfully, the FDA has said that they need to act faster, to issue warnings sooner. They will do this, in part, by issuing reports when needed, even before the information has been completely validated or confirmed. According to the FDA, the more swift “communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated.”
While this potential change in procedure won’t do anything to help the women across the country who have already developed severe, late-stage cancer because of a power morcellator, it will hopefully help prevent women in the future from suffering from the same serious, and largely preventable, harm.
Diagnosed With Cancer After a Hysterectomy or Uterine Fibroid Removal?
You may have a legal claim if you developed cancer after undergoing laparoscopic surgery in which a power morcellator was used. To learn more about filing a power morcellator lawsuit, call us at 855-445-1833 or geta started online.