Companies that manufacture medical devices used to have to report any changes they made to the devices to the FDA. On Tuesday, the FDA announced that it would no longer make companies report this information, except when they apply to recalls or safety concerns. Defective medical device lawyers at Pintas & Mullins highlight the importance of this news and how it will affect patients.
The requirement was called an "806 report," which device makers considered a burden because of the extra paperwork and tasks companies had to perform. It was also a legal burden, as all the documentation would provide ammunition for anyone injured by the medical devices that chose to file a product liability claim against the device maker.
The reports could be used in trial to suggest or even prove that certain versions of a product were dangerous or unsafe. Companies would also have to submit copies of all written correspondence discussing changes made to medical devices.
The FDA proposed the 806 report to make sure device makers kept the FDA informed on any device tweaks that were intended to reduce health risks. It would have included any changes made to previously sold products and those that are not yet being sold. On Tuesday, however, the agency deleted the 806 reporting requirement, likely to appease controversy with device manufacturers. The FDA also nixed many other proposals that would affect recall reporting requirements.
A perfect example of how more reported data from medical device makers could be problematic for them in court is the da Vinci Surgical System. Many hospitals now have surgical robots, which cost millions and are marketed as being safe, more efficient alternatives for minimally-invasive surgeries.
Surgical robots are most often used in gynecologic procedures, such as to remove bladder cancer and ovarian cysts. The company that makes these da Vinci robots, Intuitive Surgical, have long-claimed that they lead to fewer complications and shorter hospital stays, despite a glaring lack of evidence to prove this.
Researchers have started taking the matter into their own labs. One of the more recent studies, conducted by Columbia University, found that surgical robots actually caused higher rates of complications, particularly in surgeries to remove ovaries and ovarian cysts. The study was recently published in the journal Obstetrics & Gynecology. In 2013, Columbia researchers also noted that robotic surgery for hysterectomies did not provide better patient outcomes yet resulted in exorbitant costs.
We recently reported on another similar study done by Johns Hopkins, which found dozens of examples of horrible-gone-wrong surgeries that were never reported to the FDA. Based on the information they were able to gather, Johns Hopkins researchers determined that serious incidents from da Vinci robots were vastly underreported.
Researchers analyzing data from da Vinci robots encourage patients to stop and seriously consider whether using this expensive technology will actually benefit them. The types of surgeries robots are meant to replace (called laparoscopic surgeries) are already minimally invasive, using tiny incisions and are not especially painful. On average, the complication rate for ovarian cyst removal is about 2.7% for laparoscopic surgeries; for robotic surgeries 3.7% of patients suffer complications, despite costing $3,000 more to perform. So, at least for ovarian procedures, using robots turn out to be more expensive and result in more complications that traditional surgery.
Da Vinci robots cost millions of dollars and many experts believe that hospitals are only buying them to stay ahead of the curve in the ultra-competitive healthcare field. Researchers believe that much more research needs to be done before surgical robots are accepted as the standard of care in U.S. hospitals.
Complications resulting from robotic surgeries can also be much more dangerous than those suffered in traditional procedures. The FDA database points to problems in software, battery function, and issues with the robotic lens clarity. There are also reports of "freak accidents," when robots would not let go of tissue or severely burned patients.