FDA urges hospitals to report medical device issues
The US Food and Drug Administration pushes hospitals to streamline their process of reporting problems related to medical devices.
After receiving reports about the potential risk of using hysterectomy surgery devices, the FDA is said to be enhancing the agency’s current reporting system by determining how a medical device causes deaths or injuries. They are also looking at the possibility of forcing all hospitals to submit death and injury reports related to the issue.
The FDA is currently targeting laparoscopic morcellators following the death of a 51-year-old woman who died from uterine cancer. According to reports, the Brigham and Women’s Hospital did not report a case in which a power morcellator reportedly triggered the proliferation of cancer cells in the patient’s body. Meanwhile, the U.S. Government Accountability Office is currently conducting an investigation and will be releasing a report in January.
If you or someone you know has developed cancer after undergoing a surgery involving a power morcellator, get in touch with a lawyer from Williams Kherkher at (888) 220-0640.