In recent decades, the introduction of new drugs and implants has often been accompanied by enthusiastic acceptance by the medical community. However, there are cases in which this initial enthusiasm was dampened by unexpected complications.

A typical example of this is the case of silicone breast implants that were manufactured in the early 1960s by Dow Corning and were successfully used by plastic surgeons for years. Throughout the 1980s and 1990s, some reports claimed that Dow Corning’s silicone breast implants caused systemic health problems, which led to numerous lawsuits beginning in 1984 and culminating in a 1998 multi-billion-dollar class action settlement. As a result, Dow Corning was in bankruptcy protection for 9 years, ending in June 2004. A number of large, independent reviews of the scientific literature, including the U.S. Institute of Medicine, have since found that silicone breast implants do not appear to cause breast cancers or any identifiable systemic disease. Silicone is, once again, routinely found in breast implants.

Recalls of Hip Implants

Orthopaedic surgery has a number of examples of recalled implants. In 2008, Stryker voluntarily recalled the Trident PSL Acetabular and Hemispherical Acetabular Cup because of poor fixation, squeaking, and improper seating due to broach mismatch that resulted in fractures. Other implants have been discontinued because of poor performance but were never actually recalled.

Sulzer Medica issued a voluntary recall of its Inter-Op metal-on-metal (MoM) shell in January 2001, after a series of adverse reports from surgeons led to the discovery that a lubricant had leaked into the manufacturing device coolant and contaminated approximately 25,000 units, from which 17,500 were implanted. The lubricant was a mineral oil-based substance that remained as residue and prevented bone in-growth, resulting in loosening of the implant. In the authors’ department, of the 163 Inter-ops implanted, 11 were revised because of the manufacturer’s recall at an average of 1.1 years. The overall survivorship rate for all-cause-revision was 91.3%; this rate increased to 97.5% at 9 years when excluding the recalled hips.

Articular Surface Replacement (ASR) hip resurfacing and MoM arthroplasty system were introduced in early 2004. In September 2010, DePuy Orthopaedics recalled the ASR hip implants. Data from the National Joint Registers of England and Australia found that the ASR Hip Resurfacing System had a 12% revision rate, and the ASR XL Acetabular System had a revision rate of 13%. Reasons for failure include loosening, fracture, dislocation, and rarely, a localized soft tissue reaction, called “pseudotumour.”

Jameson et al reported on 214 ASR resurfacings, 60% in men and 40% in women, with a mean follow-up of 43 months. There were 12 revisions (5.6%) and the overall survival was 93% (89% for hips with acetabular components smaller than 56 mm in diameter). Lower diametrical clearance and the subhemispherical acetabular component may have contributed to the higher failure rate when compared to other designs.

Langton et al reported a 25% failure rate at 6 years for the ASR resurfacing and a 49% failure for the ASR THR. They concluded that the design of the ASR acetabular component and its predisposition to edge wear were likely to be the most important contributors to failure. They also reported that abnormal wear at the head neck junction may have been a major contributing factor to the development of pseudotumour in MoM hip replacements using bearing diameters of 36 mm and greater.

In the authors’ department, 594 ASR resurfacings were implanted over 80 months with a mean follow-up of 5 years. Overall, we had 16 (2.7%) failures, five femoral neck fractures, two acetabular component loosening, two femoral component loosening, two avascular necrosis of the femoral head, and three infections. Two cases were revised since the recall was announced. One for fear of having a recalled implant and one because of high ion levels, both in well-functioning prostheses. The survivorship rate was 97.3% at 7.5 years. We have no revisions for pseudotumours. Given the wide discrepancy in clinical outcomes with the same implant, there seems to also be technique and patient selection variables at play.

Alerts and Recommendations

On April 2010, the British Orthopaedic Association (BOA) issued a medical device alert for all MoM hip replacements with specific recommendations for follow-up, testing, and metal ion levels without highlighting a particular device. In February 2011, the Canadian Orthopaedic Association (COA) issued similar recommendations but pinpointed ASR specifically. DePuy sent a letter, prepared by lawyers, to all patients, which included recommendations for evaluation and treatment.

However, many of these recommendations were not based on solid scientific data. We issued a letter to all of our patients explaining the situation and discussing our outcomes. We reassured our patients that in the absence of pain or symptoms, serious soft tissue reactions were rare. We closely follow our patients annually, evaluating them clinically and radiographically and by measuring cobalt and chrome ion levels. In the presence of symptoms or high ion levels, an MRI using metal artifact reduction sequence (MARS) was routinely performed.

Recall is an unfortunate word to use for any implanted material, and some have argued that the word should be changed to medical advisory. It is essential to closely follow patients, answer all their questions, and calm their anxiety. Use of the term recall leads to an expanding wave of hysteria, fanned by lawyers and the Internet, that can lead to unnecessary or even risky actions. In many cases, the true reasons for failures are multifactorial, including improper patient selection, surgical technique, and implant design.

As we are currently dealing with incomplete data in a very volatile environment, it is imperative that cooler heads prevail and that a panel of experts be consulted anytime an official position is taken by any association. All recommendations should include the level of evidence on which they are based. Our goal should be to minimize needless fear while keeping both surgeons and patients informed.

Key Points

  1. The use of the term “recall” when it comes to implants is controversial. The medical community may be better served by terms such as “medical advisory.”
  2. Given the mounting hysteria surrounding a recall, communicating and informing all affected patients is very helpful in mitigating undue stress.
  3. Professional associations should communicate official recommendations based on the informed opinion of an expert panel. The level of evidence behind the recommendations should also be cited.

References

  1. Blumenfeld T.J., Bargar W.L. Early aseptic loosening of a modern acetabular component secondary to a change in manufacturing. J Arthroplasty. 2006 Aug;21(5):689-95.
  2. Jameson S.S., Langton D.J., Nargol A.V. Articular surface replacement of the hip: a prospective single-surgeon series. J Bone Joint Surg Br. 2010 Jan;92(1):28-37.
  3. Langton D.J., Jameson S.S., Joyce T.J., Gandhi J.N., Sidaginamale R., Mereddy P., Lord J., Nargol A.V. Accelerating failure rate of the ASR total hip replacement. J Bone Joint Surg Br. 2011 Aug;93(8):1011-6.
  4. Mistry A., Cahir J., Donell S.T., Nolan J., Toms A.P. MRI of asymptomatic patients with metal-on-metal and polyethylene-on-metal total hip arthroplasties. Clin Radiol. 2011 Jun;66(6):540-5. Epub 2011 Apr 1.

Reprinted with permission from the Fall 2011 issue of COA Bulletin