My friend Angela is in the middle of a debacle that probably should surprise no one, but is just as difficult and frustrating all the same.
Several years ago she had surgery. Not long afterwards, she had new symptoms that made her surgeon take pause… eventually it was discovered that the cause of the problem was a mesh fabric used as a part of the surgery. It wasn’t left there by mistake; it was part of the surgery. It was supposed to be there. It was manufactured to be left in someone’s body. It was new to the market, and there’s where part of the problem is. It’s called Mentor’s OB Tape.
Follow up surgery has not rectified the problem. The most recent theory is that the mesh has migrated to other areas of Angela’s body. She is left with problems and pain. The next step is probably another surgery — seek and remove — find those other pieces of mesh in other places, dig them out, replace them, sew them into place. Bloody, messy, ugly, horrible.
Here’s the kicker: Recently Angela learned that the manufacturer of the mesh realized there were problems with rejection of Mentor’s OB Tape soon after it was introduced to the market — meaning — just after Angela’s original surgery. Did they recall it? Or notify the hospitals that had purchased it of problems? No. Instead they just quietly withdrew it from the market and replaced it with another mesh. Now there seem to be thousands of women who have had similar symptoms and rejection problems, like Angela’s. Lawsuits are being filed. Thousands of warning websites exist. There are problem reports on the NIH website.
Angela is quite the detective. She has been emailing the researchers who published the original studies that said there were problems with the mesh. Some have replied to her. She has even tracked down the doctor who holds the patent for the mesh who now lives in France.
I have to wonder whether he is French. Or did he flee the US in anticipation of the lawsuits?
This is one more in a series of substances and products being approved by the FDA and used on (what turns out to be) guinea pig human patients, to make the ultimate discovery that it’s harmful to those patients. In some cases, patients have died after their guinea pig experiences. (I do not know if that’s the case with Mentor’s OB Tape.)
And what can patients do to protect themselves? In the short term, probably nothing except to look at the bigger picture of what’s happening at the FDA approval level. We’re hearing too frequently of approvals gone awry. I don’t know if it’s the case with this mesh, but too many approvals are taking place because research that turned up problems is being hidden by the manufacturer seeking approval.
No easy answers — just a warning that anyone can be a victim of the system. Angela was. I was. And you can be, too. And this will continue to happen until the FDA begins requiring access to all the studies being done about newly introduced drugs and materials — not just those good outcomes the manufacturers want them to see.
Update! (4/19/08) — Angela has started a blog — her experience, research, surgeries and lawsuit. Check it out.