There are few things in life less enjoyable than major surgery. Unless of course, it is a repeat of the same major surgery. This may be something that recipients of Johnson & Johnson's DePuy unit ASR XL Acetabular System and DePuy ASR Hip Resurfacing System must face. These medical devices are used in hip replacement surgery and, due to data that shows the failure rate to be well above that which was expected, the company is recalling these products.
A recall of a product actually placed inside the body is going to be more challenging than your average car recall, but it is necessary. According to a report by NPR, 13 percent of those who received the ASR hip replacement had to have it removed and replaced. The Resurfacing System, available only outside the U.S., had a replacement rate of 12 percent. In an email to NPR, DePuy confirmed the "the generally accepted standards" hold that no more than 5 percent of the hip replacements should themselves need to be replaced. That is less than half the rate of failure of the J&J devices.
The symptoms of possible failure of the ASR hip replacment system are swelling, pain and even difficulty walking. On-going symptoms can signal a loose implant, fracture of the bone around it, or the dislocation of the implant's ball and socket, the company says.
NPR reports that the company has already taken the devices off the market; but how to actually recall those already implanted in patients? If any patient who has had a hip replacement is having any of the symptoms, they should contact their surgeon to find out what kind of device was used. A general care physician may also be able to help patients follow up with the hospital where the surgery took place to get more information. Tests such as x-rays and blood tests can then be performed to try to ascertain how the replacement is functioning. If necessary, the device can be removed and replaced with additional surgery.
DePuy has a section on its website containing recall information. On the site, the company says it intends to pay for "reasonable and customary costs of monitoring and treatment ... associated with the recall of ASR." A help line has been established for patients with questions. Patients in the U.S. and Canada can call the toll-free number 888-627-2677. The U.S. and Canada call center will be active from 8 a.m. to 9 p.m. EST, Monday through Saturday.
As NPR reminds us, this is the eleventh recall since last September for Johnson & Johnson.