New Mexicans advised to have robotic surgery may be wise to heed a New Jersey woman’s experience as a warning to proceed only after expert consultation about every available medical option. After suffering a severe internal burn injury during a robotic hysterectomy in May of 2013, a 45-year-old mother currently faces a third surgical repair while living on long-term disability and in constant fear of losing her job. She says she had no idea the device her doctor planned to use had been linked to many prior injuries. Such ignorance is purportedly common and primarily caused by a combination of the Food and Drug Administration’s lack of legal authority to compel physician disclosure and widespread hospital failure to make required reports of such surgical errors.
According to a Department of Health and Human Services report, the number of hospitals that reported at least one adverse outcome fell by 37 percent from 2003 to 2007. Likewise, an FDA report indicated that hospitals reported just 15 percent of an estimated 1.1 million cases of medical error involving medical devices in 2003.
According to a surgeon and surgical outcomes expert, one contributing factor to the problem was that studies needed to test for safety hazards can’t be conducted as quickly as the surgical equipment is being manufactured and distributed. To date, the device alleged as the cause of a serious injury in this medical malpractice suit is the only one with FDA approval for soft tissue surgeries like prostate and gynecology operations.
The underreporting of surgical errors may be the most compelling reason for those who have suffered injury from an operation to seek compensation. Lawyers may be the most qualified to negotiate for fair economic compensation on behalf of their medical malpractice clients.
Source: Bloomberg, “Unreported Robot Surgery Injuries Open Questions for FDA“, Robert Langreth, December 29, 2013