By Atul Gawande
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 1-inch gap in her muscle wall — and, protruding through it, a choked-off, purple, 6-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.
Someone had infiltrated the supply chain somewhere between Sherman, Texas, where the authentic mesh was manufactured, and Boston, where I’d operated on the patient. The original lot had gone to a Memphis, Tenn., 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. 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.
I 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.
In the name of safety and simplicity, we could try to restrict medical manufacturing and distribution networks to our borders. 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.
So we’re left only with vigilance — police work. Put enough FDA inspectors on the ground and tracing technology on the goods and we 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 FDA 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.
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.
Atul Gawande is a surgeon at Brigham and Women’s Hospital in Boston and a New Yorker staff writer.