Surgical Robot Burns Hole In Woman’s Bowels

The medical device industry was worth $405 billion worldwide in 2017.

Medical device makers spend millions in D.C. lobbying for special treatment, aid in hiding medical errors 

An NBC News analysis found that since 2017, the 10 largest publicly traded medical device companies in the U.S.  have spent more than $36.5 million on efforts to influence rules and legislation.

“[Lobbying] makes things easier for industry, [and] worse for patients”

NBC News – After Teresa Hershey nearly died from complications of a hysterectomy, she wanted future patients to know about the potential dangers of choosing robotic surgery for the operation.

In 2013, the California woman added a detailed account of how the robot that operated on her had burned a hole in her bowels to a database maintained by the Food and Drug Administration.

The database is meant to warn the medical community about the risks associated with medical devices. Hershey’s was one of hundreds of similar accounts about the same robotic device.

But earlier this year, the FDA made a rule change that could curtail that database, which was already considered to be of limited scope by medical researchers and the FDA itself.

The new rule, which had been sought by medical device manufacturers, opens the door for a decrease in reported information for nearly nine out of 10 device categories, an NBC News analysis found.

It could allow manufacturers to submit quarterly summarized reports for similar incidents, rather than individual reports every time malfunctions occur, meaning there will be much less detail about individual cases.

“They’re taking away the detailed reports,” said Hershey, who is now an advocate, working with other victims harmed by devices. She sued the maker of the robot, and the suit was settled in May.

She was among those who voiced their opposition to the rule change to the FDA, writing to the agency that she believed it would lessen what the public could learn.

While her own report would not have been affected, she is concerned about the level of detail in reports from device makers, which form the vast majority of the database. “If they take that out, we’re not going to know what’s going on. Why do we even have the reports in the first place?” Read more. 

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