As litigation soars in Ireland over the metal-on-metal hip replacement implants The US Federal Drug Administration has stepped in and has demanded that manufacturers report any problems with the implants, especially problems caused when bits of metal fall into the soft tissue around the implant caused by the rubbing together of the metal parts.
On May 6th the agency ordered 21 manufacturers of metal implants to conduct post market surveillance studies. They were given 30 days to submit a research protocol. The FDA can impose severe penalties if the manufacturers do not comply with the order.
Speaking today about this latest development, Liam Moloney, a Naas Solicitor who is handling a number of claims from affected patients who received the DePuy hip implants said, “this request comes less than a year after the FDA announced a recall of DePuy Orthopaedic’s ASR hip replacements system after reports that the device was failing at a higher than expected rate. Many Irish patients have had to have unnecessary revision surgery and have been left with pain and reduced mobility”
Traditional artificial hips are made of metal and ceramic but the newer metal-on-meal devices were designed to be stronger and more durable. Metal debris can flake off into the soft tissue muscles surrounding the implant which causes the device to loosen, dislocate or even fracture the bone it is attached to. It can also cause a type of blood poisoning known as metallosis.
Mr. Moloney added “the FDA’s order is a signal to the industry that they need to review entirely their use of metal-on-metal hip implants and comes in response to adverse reports that have increased at an alarming rate, both in Ireland and throughout Europe. The British Hip Society stated that data released in March showed a 49% failure rate for the DePuy ASR after 6 years of use and Irish figures may be similar”
This announcement comes less than a year after DePuy Orthopaedics announced a recall of about 93,000 metal-on-metal hip replacement systems.
For further information please contact Liam Moloney.
Tel: 045 898000
Mobile: 087 2726759