By ATUL GAWANDE
The New York Times
May 12, 2007
As I read about the melamine-tainted pet food, and about the hundreds in Panama killed by phony glycerin from China, I remembered a patient I once saw. She was a dancer in her 40s who had hobbled into the emergency room one October night with a painful, bulging mass in her groin. I gently put my fingers to it. It was beet-sized and firm. When I placed my stethoscope on it, I heard gurgling. This was, I told her, a strangulating hernia — a rent in her abdominal wall had trapped a loop of intestine. The swelling was the knot of bowel; the gurgling, the fluid inside.
She was at risk of gangrene and agreed to an emergency hernia operation. It’s not a complicated procedure. But there are still plenty of ways it can go wrong. Inside her, I found the hernia defect — a one-inch gap in her muscle wall — and, protruding through it, a choked-off, purple, six-inch length of bowel. I opened the gap wider, pushed the bowel back in, and thankfully it pinked back to life. We’d gotten there in time. I closed the hernia with a polypropylene mesh cut to size. It was like sewing a patch onto a torn couch cushion. The next day, she went home. I saw her two weeks later. No infection. No troubles. She’d done beautifully.
Then I got an e-mail notice. The mesh manufacturer, Johnson & Johnson, was reporting that the mesh I’d put in was counterfeit. It was fake.
Someone had infiltrated the supply chain somewhere between Sherman, Tex., where the authentic mesh was manufactured, and Boston, where I’d operated on the patient. Apparently, mesh can travel through many hands. The original lot had gone to a Memphis warehouse, and then through at least two hospital goods distributors, which sell and trade medical supplies on what turns out to be a worldwide market, like oil. Somewhere along the way a counterfeiter replaced the lot with fake mesh packaged exactly like Johnson & Johnson’s, right down to the lot number. It is believed this happened someplace in Asia. But no one really knows.
The material looked like ordinary mesh to me. But according to the alert from the Food and Drug Administration, it wasn’t sterile. And although it seemed to be polypropylene, the fibers and weave were different from the manufacturer’s. It wasn’t clear what should be done. I called the patient to come see me.
I also began to wonder how I could trust anything I use. My sterile gloves come from the Philippines, surgical sponges from China, devices and instruments from Taiwan to Texas. The ingredients for medications come from all over the world.
This is how it is now. That’s not bad, I know. But it’s not all good, either. In the effort to get the best possible results for people, it seems hard enough to make sure one’s decisions are right. I’d never considered that I had to worry about my supplies, too.
So what to do?
In the name of safety and simplicity, we could try to restrict medical manufacturing and distribution networks to our borders. This is, for example, the argument for blocking the sale of medications from Canada. It’s folly, though. Medicine’s success and affordability already critically depend on materials and distribution from around the globe. Yet market forces aren’t weeding out the shady operators, either.
So we’re left only with vigilance — police work. Put enough F.D.A. inspectors on the ground and tracing technology on the goods and we actually could block those who would put an industrial solvent in children’s cough medicine and fake, unsterile material in our surgical supplies.
This we don’t do, though. The number of F.D.A. inspectors has actually been cut — partly because of small-government ideology and partly because of tight budgets. And still they’re finding more cases than ever. (In recent years, they’ve found counterfeit Lipitor, Viagra, Botox, Zyprexa and birth control pills, among others.) We need many times more inspectors. But nothing like it has been considered. That is no longer acceptable.
I saw my patient and told her about the fake mesh. She was stunned. We then considered what to do. It wasn’t clear the mesh would hold; and in many other patients, it became infected and had to be removed. But she’d done all right so far, and redoing the repair is major surgery. So she decided to wait and see what happened.
Given the alternative, doing nothing and hoping for the best was a wise choice for her. But it’s a bad choice for the rest of us.