Transobturator Tape
How many women are suffering?

Imagine buying a new car and finding out later that 13 percent of them fall apart for no reason. Imagine buying a computer and finding 13 percent go up in flames. Imagine going to an accountant for your taxes, and finding out 13 percent of the customers wind up getting sued by the IRS.

You wouldn't like it very much I'm sure.

Now imagine you've got something with those kind of failure rates.

Now imagine it's inside your body.

And you can't find anybody to take it out.

***

You've probably never heard of transobturator tape if you're a man and if you're a woman, you've probably heard good things about it -- especially if you're one of those women who wind up tinkling when you sneeze or laugh.

There have been plenty of advances in treating stress incontinence in recent years, up to and including those prescription drug ads complete with puppies and fields of heather and beautiful sunsets. In terms of surgical treatments, transobturator tape (TOT tape in the field) was hailed as a big improvement over TVT tape, which, near as I can tell from my limited research, had some nasty complications.

The general idea is that via a minimally invasive surgery, the tape is inserted like a sling to lift the bladder back in place. Pretty quick surgery, pretty quick recovery, and from what I can tell from the medical literature I can find, a high rate of success.

The FDA approved a TOT tape from the Mentor Corp. in September, 2003 based on 11,000 successful TOT tape insertions via Mentor's operations in France. It would interesting to learn more about this application because less than two years later a leading medical journal was reporting a 13 percent complication rate.

Is 87 percent success good enough for the FDA? A Mentor press release said "millions" of women suffer from stress incontinence, which would mean, at one million surgeries, 130,000 problems to 870,000 successes. Could a government agency get away with allowing that many failures?

Apparently so.

***

You've heard the statistics before -- a 1 in 10,000 chance. These sort of things always hit home with me because my mother-in-law (via the ex-wife) wore an eyepatch. It was a 1 in 10,000 chance she could lose an eye to shingles. She did.

I'm living it again.

My girlfriend is in the 13 percent failure rate for TOT tape.

But that's only the beginning of the problem.

***

The typical American response in situations like this is sue somebody. In The First Dumpling's case, that's not an issue. She's had two doctors and both have been excellent. The first added the TOT tape as part of a hysterectomy, and once it started eroding into the vaginal wall, the doctor did the follow-ups for free. When problems continued, the doc referred her to the best urogynecologist in a 100-mile area. He took a couple of whacks at it, too.

Each time, the procedure was essentially the same. Find as much of the tape that was exposed and snip it out. Last time he took a whack at it, I'd already read the research which prescribed taking it all out.

And my heart sank when he said he got as much as he could safely get.

The very end of the tape goes way up into the leg, near major arteries, nerves, all that. The doctor was exactly right -- do no harm, be conservative, blah blah blah.

I didn't show it, but I furious. I knew he was the expert, but I have this curse of seeing things clearly -- if her body had been rejecting this tape at every stage, why would it just stop now? I knew it was just a matter of time.

That was a few months ago.

You can guess what's going on now.

***

Dumpling found an expert out in California and gave his office a call. First question from the receptionist -- how many surgeries? Think about that for a minute: It's not even on their radar until multiple surgeries.

For the record, she's had four so far. Also for the record, I don't know if she has a Mentor tape or not. There's a couple different brands on the market and I only mentioned Mentor because I found them on Google. Like I said, the typical American response is to sue somebody, and I don't want it to be me. I don't know if that failure rate involved Mentor tape. All I'm saying is somebody's tape is coming with a great big asterisk.

I should also say for the record that neither of her doctors are still using this particular tape. They've had other patients with complications, though I get the impression that the other cases are not as severe. As her second doctor put it: "If there was somebody in this town who could fix this, I'd send you to them."

When the doctor recommends researching specialists at the top hospitals in America -- Duke, Johns Hopkins -- you know things aren't looking good. She went to see a specialist at the Medical College of Virginia, who said he'd try removing the final pieces though he'd never done it before. One of the doctors along the way, I forget which one, suggested talking to a urologist who does surgery on men, because it might have to be removed by cutting through the abdomen or leg.

Good God. Cutting out the final piece would be heavier surgery than all the others combined.

***

On days like this, I miss my former life as a mainstream reporter. You could call people up and they had to talk to you; now I'm just a crank caller.

There sure are some questions I'd like to ask.

Does the FDA follow-up on things they've approved to see if something starts showing up later? How long does it take doctors and medical journals to identify problems? Is there any responsibility for the manufacturers to try and find out the commonalities between the failures and maybe come up with a warning label? How do manufacturers know when to pull something off the market -- when the doctors start complaining or the lawyers start suing?

In the meantime, Dumpling keeps working the phones trying to find an expert. She uses a variety of methods to manage the pain in her upper thigh, and there's a host of other problems (and their management) that are too personal to detail publicly. Her attitude, even after more than a year of this mess, remains surprisingly good.

The irony in all of this is that the surgery, ostensibly, worked. She can laugh or sneeze without worry. Apparently, even after pieces of tape are removed, there's scar tissue or something keeping the bladder in its proper place. Thing is, she traded big problems for a small one.

There's a saying for this.

The cure is worse than the disease.

-30-

Update 2-14-06: After two more surgeries (one major, one minor) the Dumpling has been problem-free for about six weeks. If I was really worried about lawyers, I'd say more about the surgeries, but it's pretty private stuff, so I'll pass.

Mr. Marshall needs to explain, for first-time visitors, the origin of the nickname The First Dumpling. In 2003 the FX Network floated plans about making a game show out of running for president, and while discussing the idea of trying out for the show with friends, the question came up as to what would be the proper term for the president's girlfriend. The FX show American Candidate never got off the ground, but the First Dumpling nickname stuck.

 

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Oct. 18, 2005