Pinnacle recipient’s on-camera revision surgery reveals extensive injuries
March 27th, 2012 by Kurt Niland
Maureen Bayles, a resident of Richmond, England, just to the west of London, told the British Broadcasting Corporation’s (BBC) Newsnight program that when she had to get her hips replaced in 2005, she was told that DePuy’s Pinnacle implants were the best way to go. But now, just a few years later, she is undergoing revision surgery to have the failed Pinnacle hip implants removed.
“When I went to the hospital, I was told I was going to get this new hip joint which was a state of the art joint. It was metal and it would last almost my life—probably my lifetime,” Ms. Bayles told the BBC.
But instead of enjoying a better, pain-free quality of life, Ms. Bayles began to experience problems linked to the metal hips that she’d never expected, including swelling in her lower abdomen, which ultrasound tests revealed to be a buildup of fluid. Concerned, Ms. Bayles and her surgeon, Dr. Tony Nargol, decided to remove the first Pinnacle implant – a procedure that was recorded by the BBC’s Newsnight cameras.
“I’m glad we got her in time,” Dr. Nargol says on the video, as he removes bits of debris from Ms. Bayles’ deteriorated hip, described by the Newsnight reporter as “a mixture of rotting flesh and cobalt and chromium debris” that accumulated around the Pinnacle implant.
“Metal debris everywhere,” Dr. Nargol noted on camera. “The front wall of the pelvis has just been eaten away. It really is quite significant, the damage.”
Orthopedic Surgeons in the U.K. have called for an end of the Pinnacle and other all-metal hip implants designed with a large head. As an investigation conducted jointly by the BBC and the British Medical Journal revealed, modifications were made to these implants in a bid to prevent dislocation and increase movement after they had been approved for use by regulatory agencies in the U.K., the United States, and other countries. These modifications included “making the ‘head’ larger and part of the ‘stem’ shorter,” according to the BBC, and are thought to be the reason why the implants appear to be failing at alarmingly high rates.
It would be one thing if the Pinnacle implants simply failed and needed to be replaced, but much like DePuy’s ASR implants, which the company recalled in 2010, the Pinnacle potentially casts metal debris into the body, destroying bone and tissue around the implants and making future revision surgeries exceedingly difficult. Doctors also worry about long-term damage to health that the implants may pose in other ways, including blood poisoning and cancer.
Dr. Nargol told the BBC that he’s seen levels of toxic metals in patients’ blood samples “ten, twenty, fifty times the normal levels.” Dr. Nargol added that one patient had nearly 300 times the normal level of those metals present in the blood.
Despite these findings and growing numbers lawsuits filed against DePuy in British and American courts, the Pinnacle hip implant remains on the market.
Internal DePuy documents show the company knew as early as 2005 that the all-metal hips could be a problem, yet the recall of ASR devices wasn’t launched until August 2010, while the Pinnacle remains on the market.
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