The Human Cost of FDA Decisions: A Faulty Hip Replacement Disrupts a Young Man's Life

April 25, 2012 | 3:21 pm
Michael Halpern
Former Contributor

After sharing the personal experiences of two separate UCS supporters—Gwen and her mother, Maxine and Elsa and her husband, Dan–with drug and device safety, I’ve heard from others who are also brave enough to share their stories with us. Henry H.’s tale about his metal on metal hip replacement is particularly touching, showing how a faulty medical device can have consequences not just for the victim but for his entire family.

Henry lives in western Massachusetts, where he has worked as a registered physical therapist for twelve years. “My condition inspired me to pursue this profession,” he said. “Physical therapy and yoga are very beneficial to my physical and mental health.”

Henry has ankylosing spondylitis, a type of auto-immune arthritis affecting the axial skeleton (mainly the spine and hips). Despite his active lifestyle, severe osteoarthritis had eroded the cartilage in his left hip. The arthritis became so severe that the joint was bone-on-bone.

Henry, his daughter Jasmine, and Biscuit, the family guinea pig.

Pictured are Henry, his daughter Jasmine, and Biscuit, the family guinea pig. A faulty hip replacement Henry received at age 38 had significant negative consequences for him and his family--and his experience likely could have been prevented.

He traveled to Boston in order to get the best care for his condition. His doctor informed him that he would need a hip replacement—at only 38 years of age.

The doctor gave Henry several options: a plastic on metal, ceramic on metal, or metal on metal hip. “We talked through each option, and I did some independent research,” he said. “There was some risk with each, but it was ultimately my decision.” They decided that one particular metal-on-metal hip would be the best choice.

In January of 2008, Henry went under the knife, and rebounded quickly. “The recovery was very fast,” he said. “After four weeks, not only was I walking freely, I was also working and practicing yoga! For the first six months, I remember it feeling awesome.”

But the feeling did not last.

“I remember doing a simple task – hopping to avoid stepping on my daughter’s toys — when I first felt something tweak in my new hip,” recounted Henry.  “It was a strange ache, but at first I thought it was probably just a muscle spasm.”

Over the course of the next two years, the ache would come and go, but the period of pain and discomfort associated with each episode was getting longer. This was not what he had expected. “I had heard stories of people getting their hips replaced and hearing from them that it was the best thing in their lives,” he said. “But I wasn’t having that experience.”

At check-ups with his doctor, he expressed his apprehension about the pain episodes. But x-rays and angiograms didn’t show anything out of the ordinary. Then, at his two-year follow-up appointment, the doctor informed him that the device had been recalled due to the failure of the device to adhere to the bone in a small percentage of cases, requiring a complete redo of the surgery.

“I didn’t have a particularly strong reaction to the news,” he said. “There was nothing I could do but wait and see.”

It didn’t take long before it got much worse. Less than four months later, about 28 months after the initial surgery, Henry took a long drive up to Quebec. When he got out of the car, he was in terrible pain.

“It was excruciating,” Henry said. “I started walking with a cane but there were points when I need crutches, and times when I couldn’t bear any weight on the leg.”

Upon returning to his hometown, he went to the emergency room. A physician immediately knew what was wrong.

Hip replacement X-ray

An x-ray of a hip replacement taken in October 2011. The two light cylinders in the middle of the image are drawstrings from the patient's pants. The image was modified from x-ray provided by Flickr user Nicole C. Engard.

“He showed me on the x-ray,” said Henry.  “My acetabular cup [a part of the device] had migrated 90 degrees. At this point, it was the most severe pain in my life and it was evident that I would need a total hip replacement again.”

This time around, plastic-on-metal technology had improved, so Henry decided to go with that. But due to the complications from the first faulty hip replacement, the second surgery was much more invasive. This time, he was still on crutches six weeks after the surgery.

And the experience has had consequences beyond Henry’s own life.

“It has been difficult for me, but it has been especially hard for my family,” he said.  “My seven year old daughter understands that I can’t play with her the way I used to and that makes her sad. My parents have had to drop everything to help with my recovery. It’s been heartbreaking for them to see me go through this process.”

Henry is frustrated when he thinks about what could have been prevented. ““After the initial shock of realizing that my hip had failed, I was extremely upset that the device which was estimated to last more than twenty years lasted little more than two,” he said. “And when I researched other people’s stories about this particular device, I found that my experience followed a similar thread, even down to the timing on when the device started to fail.”

Some doctors had raised concerns about early signals of an abnormally high failure rate of the device. But due to a lack of adequate post-market surveillance of medical devices, the device continued to be used. Had this monitoring been better, many, including Henry, may have avoided this experience altogether.

This is part of a series of posts on drug safety reform at FDA.

In addition, because of the way the FDA’s medical device review process currently works, Henry’s device never received the initial scrutiny from the agency that it deserved. Adequate screening may have kept the device off the market in the first place.

There are economic costs as well. Johnson & Johnson, which manufactures other hip replacement technology, earlier this year set aside $3 billion (that’s billion with a “b”) dollars to deal with litigation from its faulty hip replacements. And each replacement hip surgery costs tens of thousands of dollars, costs that are often borne by Medicare.

Henry will eventually need surgery on his right hip, but he has been holding off for as long as possible. “I’m definitely more hesitant this time around,” he said.