Rejected in the US, J&J sells hip implant overseas
16 February 2012
Healthcare and consumer giant Johnson & Johnson (J&J) is now selling its hip implants in Europe and elsewhere, after the US regulator banned its sale in the US amid reports of high rates of failure of hip replacement surgeries.
J&J's unit DePuy Orthopaedics, Inc, continued to sell a related hip implant model in the US, which earlier went on the market using a regulatory loophole that did not require a similar safety review, The New York Times yesterday reported.
It is not known how many people overseas received the replacement hip after the US Food and Drug Administration (FDA) decided in 2009 not to approve it, nor the number who received the related model sold in the US.
DePuy was selling two models of the ASR Hip System, ASR XL Acetabular System and the ASR Hip Resurfacing System.
The ASR XL Acetabular System is a concave metal piece used to provide a smooth lining for the acetabulum, the bowl-shaped socket in the pelvis, while the ASR Hip Resurfacing System replaces the ball portion of the hip and has a metal stem that fits into the top of the hip bone, or femur.
The ASR XL Acetabular System first became available in 2005 in the US after the FDA gave J&J a special clearance in 2005 to market the ASR devices without first performing clinical trials to determine the safety of the products.
But since 2008, the FDA has received approximately 400 complaints from patients who received ASR hip replacements and at the beginning of 2010 DePuy said it was phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data in the US, UK and Australia.
In August 2010, DePuy issued a global recall of two models of the ASR Hip System after finding that more people than expected who underwent hip replacement surgeries experienced pain and other symptoms that led to a second hip replacement surgery, called a revision surgery.
The recall was issued more than a year and a half after the first lawsuit was filed. Many experts had said at that time that DePuy should have issued the recall sooner, due to the high number of complaints about the devices.
According to Warsaw, Indiana-based DePuy, five years after implantation, approximately 12 per cent of patients who had received the ASR resurfacing device and 13 per cent of patients who had received the ASR total hip replacement needed to have a revision surgery.
But the FDA wrote a confidential letter to J&J in August 2009 that the company studies and clinical data submitted for US approval for selling the hip implants overseas were inadequate to determine the implant's safety and effectiveness, according to a summary of the letter reviewed by The New York Times.
The FDA also told J&J it would require additional clinical data to go ahead with the application, a process which might have taken more than a year.
DePuy received the FDA response at a time when questions were being raised by regulators and surgeons abroad as well as doctors in the US on the increasing number of failures of both models of the implant.
Although it is not illegal to sell medical products overseas that have been rejected in the US, J&J never made public the confidential letter written by the FDA since it could have damaged its brand.
J&J has around 5,000 lawsuits pending because of the implants, including from patients who were crippled by the faulty hip implants.