Smith & Nephew has recalled the R3 metal liners, which are used exclusively with the Birmingham Hip Resurfacing System. The company is now facing a growing number of lawsuits from people who allege that the metal-on-metal design of the R3 / Birmingham hip is defective. Many victims have developed metallosis (metal poisoning) and required revision surgery.
Smith & Nephew Birmingham Hip Problems
Smith & Nephew manufactures the Birmingham Hip Resurfacing System (BHR), an alternative to total hip replacement surgery in which a surgeon implants a mushroom-shaped cap over the head of the femur, which pivots inside an acetabular cup and liner.
Unfortunately, recent studies have shown that hip resurfacing has serious risks, especially for older women. A study published in the Lancet in October 2012 found “unacceptably high” rates of early failure — 8.3% of hip resurfacing implants failed within five years for women over 55. Researchers concluded, “We recommend that resurfacing procedures are not undertaken in women.”
Smith & Nephew R3 Metal Liner Recall
June 1, 2012 — Smith & Nephew Orthopedics announced a recall for metal liners used with the R3 Acetabular System due to a high rate of revision surgeries — approximately 6.3% at four years, according to the U.K. National Joint Registry. The Australian Orthopedic Association found a revision rate of 2.48 per 100 observed years, compared with 0.79 for all hip replacements.
Metal-on-Metal Hip Implants
When an R3 metal liner is used in combination with a metal femoral head on the Birmingham Hip Resurfacing (BHR), the resulting implant is a metal-on-metal system. The R3 metal liners are made of cobalt-chromium that fit within an acetabular cup. When a patient walks, the metal parts grind together and release tiny particles of chromium and cobalt into a patient’s body, causing metallosis (toxic metal poisoning).
Smith & Nephew Hip Risks & Complications
Numerous studies have shown that all-metal hip implants offer no advantages over plastic and ceramic designs, but they introduce additional risks. The U.S. Food and Drug Administration (FDA) has published several warnings listing “Concerns about Metal-on-Metal Hip Implants” — especially metallosis, which is a unique risk in addition to the general risks of all hip implants.
Smith & Nephew hip implant side effects may include:
- Hip pain
- Swelling, inflammation
- Dislocation, looseness, or instability
- Bone loss (osteolysis)
- Tissue necrosis
- Bone fracture
- Bursal cyst
- Pseudo-tumors (soft-tissue growths)
- Metallosis (metal poisoning)
- Corrosion of hip implant
- Failure in less than five years
- Revision surgery
- Permanent disability
Metal poisoning from the Smith & Nephew Birmingham and R3 hip replacements could also lead to systemic reactions in other areas of the body. According to the FDA, these side effects may include:
- General hypersensitivity reactions (skin rash)
- Neurological changes
- Hearing or vision loss
- Psychological changes
- Cognitive impairment
- Kidney function impairment
- Thyroid dysfunction (neck discomfort, fatigue, weight gain, feeling cold)