When a medical device is made available to health care providers, the assumption is that it is safe for patients. Furthermore, doctors opting to use the device could also be considered another acknowledgement of safety and effectiveness. However, recent actions taken by Johnson & Johnson, a major medical device manufacturer, are causing significant concern.
Officials from Johnson & Johnson asked medical providers to send back any "power morcellators" that they've purchased. The company already stopped selling and distributing this particular device after studies showed that it could spread cancerous cells in women.
Morcellators have been used in hysterectomy surgeries and procedures to remove uterine fibroids. The problem is that doctors cannot distinguish between cancerous and benign fibroids without first removing them. In other words, efforts to remove the fibroids with this device could be causing much more harm than benefit.
Johnson & Johnson seemed to be biding time with the devices until more research confirmed the worst about the devices. It appears as though an article recently published in the Journal of the American Medical Association forced the manufacturer's hand, as they've initiated the recall process.
Although products liability concerns exist in this case as it relates to serious injuries, medical providers could also be considered responsible. After all, the device has not been sold in several months. Keeping this in mind, doctors may also have had indications that the device wasn't safe. If any doctors used the device despite having this information, then they might be responsible for some unnecessary health complications.
Moving forward, the hope is that patients will not be exposed to more danger as the result of this controversial, dangerous surgical device.
Source: Tech Times, "Johnson & Johnson recalls hysterectomy power morcellator that may spread cancer," Rhodi Lee, July 31, 2014