Hip implant concerns persisted for years

SERIOUS concerns about hip implant parts which are the subject of a worldwide recall by their manufacturer, DePuy Orthopaedics, have persisted for a number of years, with critics claiming there is a design flaw in the products.

Two types of orthopaedic products used as hip replacement parts have been withdrawn by the company amid fears that they can cause higher than expected levels of soft-tissue damage in patients which may require them to have further surgery.

However, the products have been dogged by controversy almost from the outset, as questions have been asked how the main product – the ASR XL Acetabular hip implant – was approved for use in 2005 by the US Food and Drug Administration without being subjected to clinical trials.

The FDA has subsequently received in excess of 300 complaints since 2008 from patients fitted with the implant.

The second DePuy product to be recalled, the ASR Hip Resurfacing System, which is an alternative to a traditional hip replacement was launched in 2003 but was never approved for use in the US.

Critics believe the ASR device, generates large amounts of small metal pieces as a result of normal wear and tear leading to soft-tissue damage and further complications.

Some medical experts believe the product suffers a design flaw whereby its components require replacing far sooner than their expected 15-year life span.

DePuy recognised potential problems as far back as early 2009 when it notified doctors about the importance of the proper positioning for all hip implants.

Later that year, it announced that it would phase out the ASR worldwide by the end of 2010 due to slowing sales, although the company made no reference to potential problems with the devices.

The implants were subsequently withdrawn from the Australian market in December 2009 and from the US last March, before the voluntary recall worldwide announced this week.

The controversy surrounding the hip implants is the latest among a series of incidents over the quality of products to hit DePuy’s parent company, the US pharmaceutical giant, Johnson & Johnson.

The company and its various subsidiaries, including DePuy, have now been involved in 11 different recalls in the space of the last 12 months.

The latest recall comes just after the US government warned DePuy that it was illegally marketing two other hip replacement products for treating conditions for which they had received no approval from the FDA.

Earlier this week, Johnson & Johnson recalled millions of 1 Day Acuvue TruEye contact lenses from markets in Europe and Asia because some users complained of a stinging pain when they inserted the lenses.

Johnson & Johnson have also been forced to issue several recalls of over-the-counter medicines over the past year, including bottles of Tylenol, other pain relievers and cold medicines for children and adults.

Among the problems with such products were bacterial contamination, wrong amounts of active ingredients and tiny metal shavings found in some bottles.

One of DePuy’s main overseas bases is its plant at Loughbeg, Ringaskiddy, Co Cork, which was established in 1997 and currently employs 650 staff.

A DePuy spokesperson said neither of the affected hip replacement parts had been manufactured at its Irish operation. The company stressed that its decision taken in 2009 to discontinue the ASR system was due to declining demand and its intention to focus on the development of next generation hip replacement products and technologies.

The Loughbeg facility is at the forefront of such new product development.