Whitehall man with two defective hip implants wants to be heard by the FDA
May 11, 2012 (Menafn - The Morning Call - McClatchy-Tribune Information Services via COMTEX) --Whitehall resident Steve Lorenz was just adjusting to his second hip surgery when he received a letter that startled him. Johnson & Johnson announced it was recalling thousands of its metal-on-metal hip implants.
"It was disturbing," Lorenz said. "Oh my God, I felt like a Ford truck. I got my hips recalled!"
Lorenz, a worker at Lehigh Cement Co., depends on his body to earn a living. But the defective implants continue to cause him pain. And he can't find a doctor to replace them because surgeons are afraid of being pulled into a lawsuit.
He and his wife, Patricia, will travel to Washington, D.C., next month to speak before a Food and Drug Administration panel. They hope to persuade the agency to tighten its regulations, which allowed the hip implants to reach the market without clinical trials.
Lorenz, now 51, was 48 when he underwent his first hip replacement surgery in December 2008. He endured pain for about a year before opting for the procedure.
The DePuy ASR XL, made by Johnson & Johnson, was one of the most popular hip implants worldwide. It was hailed as the solution for younger patients who wanted to return to high levels of activity soon after the operation. The new metal devices offered a larger range of motion and decreased risk of dislocation compared with traditional implants that use plastic sockets.
Lorenz never recovered properly from the first surgery, experiencing what he described as "a loosening of the joints, like I have play in there."
There was swelling around his scar, and he was constantly sore.
Lorenz was told that his pain was partly caused by his other hip, which was wearing out. The right hip would also need to be replaced before he could fully recover. Lorenz underwent a second operation in February 2010.
He had an even harder time recovering from the second surgery. He struggled to walk.
"If I walk too much at work or if I'm on my feet for too long," Lorenz said, "by the end of the day I feel as bad, if not worse, as when I needed my first hip replacement."
In October 2010, while Lorenz was planning a family trip to Maine, he received the recall notice from DePuy Orthopaedics, a unit of Johnson & Johnson.
Soon after, Lorenz received a call from his family physician, who needed to check the levels of cobalt and chromium in Lorenz's blood.
The DePuy implant is made of chrome and cobalt metals. The friction between the ball at the top of the femur and the socket liner in the pelvis has been shown to release metal debris into the bloodstream.
Patients with high levels of chromium and cobalt in the bloodstream can experience hearing and vision loss, mood swings and the creation of cysts that damage soft tissue around the prosthesis, causing the implant to fail.
Lorenz tested above the normal range for chromium and cobalt. He is still experiencing pain around his scars and has been forced to give up riding his bicycle, one of his passions. He's trying to find a surgeon who will agree to do the revision surgery.
Dr. Leo Scarpino, an orthopedic surgeon at Coordinated Health of South Whitehall, has put in at least 24 of the DePuy devices. He said Thursday he can understand why other surgeons are apprehensive about assisting patients like Lorenz. Revision surgeries are often more complicated than the initial replacement, and surgeons are concerned about the threat of litigation.
"But we still have to take care of the patients," Scarpino said, "and the last thing you want to do is run away from the patient because you have a sticky issue here. You can't do that."
Scarpino has replaced three of the DePuy implants since the recall in 2010. To merit a replacement, a patient must have elevated chromium and cobalt levels as well as pain and swelling around the hip.
"Most patients who have these hips are going to have them for the rest of their lives," he said.
Patients who are not showing symptoms should not feel compelled to seek a replacement, Scarpino said, suggesting the most sensible solution is to monitor the implant and the cobalt and chromium levels over time.
Lorenz will see Scarpino next week and is hoping he can tell him if replacement is warranted.
Mindy Tinsley, spokeswoman for DePuy Orthopaedics, said the company is concerned about patients, family members and surgeons. DePuy has made arrangements to reimburse the cost of replacements and other out-of-pocket expenses related to the recall.
"We encourage ASR patients to visit http://asrrecall.depuy.com and contact the Help Line at 1-888-627-2677 for assistance," Tinsley wrote in a statement.
Johnson & Johnson and DePuy are facing thousands of lawsuits worldwide, including some from patients in the Lehigh Valley. Lorenz is not interested in suing at this time. He just wants to be pain-free.
The Lorenzes have been invited to speak to the FDA's Orthopaedic and Rehabilitation Devices panel when it meets June 27-28 in Washington.
After four years of living in pain, Lorenz said, the least that the FDA can demand from manufacturers like DePuy and Johnson & Johnson is to compel them to run proper clinical trials before releasing implants.
milton.carrero@mcall.com
610-820-6628'
Depuy hip replacement recall
Considered a solution for younger patients needing hip replacement, the ASR XL metal-on-metal implant was recalled in August 2010 after showing a 12 percent failure rate.
The maker, DePuy, recalled all 93,000 ASR XL hips worldwide. Surgeons were told not to implant any more of them and to return remaining products.
The friction between the ball at the top of the femur and the socket liner in the pelvis was shown to release metal debris into the bloodstream. That has the potential to cause complications including hearing and vision loss, mood swings and the creation of cysts that damage soft tissue around the prosthesis.
Patients who received the implant were put under close observation. Surgeons were required to check for high levels of cobalt and chromium, an indication that the implant could fail.
Sources: Food and Drug Administration; the Medicines and Healthcare Products Regulatory Agency in England.
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