One of the most massive recalls of a medical device in U.S. Food and Drug Administration history occurred on Aug. 24, 2010 when agency officials announced a voluntary recall of the DePuy ASR TM total hip system because of alarming new research that the devices were failing at rates as high as 13 percent.
What followed were recalls of tens of thousands of DePuy systems and a massive wave of DePuy hip implant lawsuits from patients who suffered excruciating pain and serious health problems as a result of these failed systems.
Since then, it has been reported in major media outlets and alleged in DePuy lawsuits, the failure rates actually have been significantly higher, reaching as high as 40 percent.
FDA data show that the agency was flooded with Adverse Event Reports involving failures with the DePuy ASR system and with metal hip implant systems from other manufacturers.
FDA records also show that physicians were sent the following information about the dangerous side effects that could be caused by these devices:
- Case reports in the medical literature have suggested the potential for systemic effects of elevated metal ion levels resulting from device wear in metal-on-metal (MoM) hip implants. These effects have included:
- General hypersensitivity reaction (skin rash)
- Neurological changes including sensory changes (auditory, or visual impairments)
- Psychological status change (including depression or cognitive impairment)
- Renal function impairment
- Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold
- Based on these limited number of case reports in published literature, the true incidence or prevalence of adverse systemic effects from MoM hip implants is not known at this time.
- A patient with systemic symptoms and a MoM hip implant is more likely to visit his or her general practitioner or medical specialist rather than his or her orthopaedic surgeon, it is imperative that all health care providers be aware of the potential role of metal ions during their evaluation of their patients with MoM hip implants
- At the current time, the FDA believes there is not enough evidence in the U.S. demonstrating a correlation between a metal ion level and the presence of localized lesions, clinical outcomes and/or the need for revision surgery.
- If the patient’s systemic findings are thought to be related to the MoM hip implant, the patient should follow-up with his or her orthopaedic surgeon to determine the appropriate course of action.
- Report any adverse systemic events which are believed to be related to MoM hip implants to the FDA through the agency’s MedWatch.