A yarn on the front page of this morning’s WSJ points to a broad gray area in medicine: What constitutes human experimentation? The issue can be especially tricky when it comes to approved medical devices, which can sometimes be modified without receiving new FDA approval.
A prominent heart surgeon implants a slightly modified version of a ring used to seal leaky heart valves. The ring is similar to one that’s already been approved. Is that experimentation? A lawyer who represents device companies told the WSJ that it “would be a nightmare for the FDA, and companies, if they had to apply for each tweak” to an already-approved device.
The surgeon who implanted the modified device was an author of a medical-journal article that described the “initial experience with a new ring” — language that suggests the doctors implanting the ring should have done so as part of a clinical trial, according to one doctor who didn’t perform the implants.
The surgeon said the article wasn’t a clinical trial report but part of a database of heart-surgery results, and patients consented to be in the database. And he said the modification — bending the ring into a new shape — didn’t introduce new materials.
A patient who had to have her ring removed, and who filed a lawsuit, says she wasn’t informed that the modified version of the ring wasn’t approved by the FDA at the time of her initial surgery. (It was approved later on.) “I didn’t want to be a guinea pig,” she said.
The story is complicated, and there’s a lot of back and forth that we won’t get into here. It’s worth reading the whole thing for yourself.
Photo by CarbonNYC via Flickr