- In 2000, Sulzer Orthopaedics faced a major crisis regarding its hip implants. Some patients who received a total hip replacement experienced significant pain in the hip area. This was due to a defect in the manufacturing process that led to poor bone attachment by the implant. As a result, Sulzer issued a recall, but there were many problems associated with this. Primarily, Sulzer should be blamed for the manufacturing of a defective product as well as its poor management of the recall. However, the FDA should receive some accountability as well. These problems will be discussed further, as well as some suggestions to prevent them from arising again in the future.
- Clearly, if there were no defects in the manufacturing process, patients would receive a functioning implant and not experience any problems. Therefore, Sulzer could have avoided this whole incident by employing a stricter review process. In 1999, they moved production to a different location, and eliminated a supposedly unnecessary step in their manufacturing process [a]. Unbeknown to Sulzer, the acid bath they removed, benefitted the implant by eradicating some harmful oil residue. Following this incident, revisions to their review process should be enforced to avoid similar problems. Any changes regarding the manufacturing process have to be carefully reviewed and rigorously tested before implementing them. This especially applies to a medical implant, where unpredictable host reactions cause unpredictable effects and should be tested; its removal and replacement is also extremely difficult and adds pressure to deliver a fully-functioning implant.
- Another problem caused by Sulzer was their poor management of the recall [b]. At its conclusion, those who received the implant had a general feeling of distrust, and some of the surgeons no longer recommend their product. Arguably, the recall itself did not cause this reaction, but Sulzer’s management of it. A prime example would be Tylenol, which in 1982 issued an immediate recall. Firstly, Tylenol was only financial hurt for a brief period and recovered after a few months. Secondly, their public image was boosted, and people praised their superior management [c]. Thirdly, this example exemplifies the unnecessary need to identify the problem before issuing a recall. By waiting for outside contractors to find the manufacturing defect, time was wasted and ultimately Sulzer’s public image deteriorated. Sulzer was negligent in this respect, and should have adopted a more immediate and transparent response like Tylenol. Furthermore, Sulzer was contradictory in their public statements which overall worsened their profile. At first, they were willing to accept blame and subsequently offered to correct the faulty implant. However, over the duration of the court trials, the blame was assigned to third parties [b]. The general public sees these inconsistencies as discreditable and could have been avoided had Sulzer acted on their first statement of remediation.
- However, Sulzer should not receive sole blame. To a lesser extent, the FDA is at a fault. The FDA, whose mission is to protect public health and ensure safety of medical devices [d], only plays a spectator role in this recall. The FDA received information from Sulzer regarding the product failure and a recall notification[b]. However, there could be a potential problem of significant delays or withheld information for the interests of the company instead of the public. Instead, if the FDA was made aware of this situation from primary sources and if the FDA had a greater authority, they could demand a timelier response and recall from Sulzer. Instead of being notified by Sulzer, the FDA should implement an implant registry to have primary records that identify product failures, similar to the NJR in Australia. Additionally, more stringent regulations are needed on the manufacturing process and on recall actions; I believe the 510k approval is inadequate. Similarly, the FDA plays little role in product recalls which is unsatisfactory. I believe that prompt communication to patients, surgeons and the general public should be enforced in future recalls and performed by both the company and FDA.
- Both Sulzer and the FDA are culpable for this recall crisis. Sulzer should have employed a more rigorous review of their manufacturing process, and the FDA should have better regulations in place to prevent this from happening. Sulzer’s management of the recall was poor in that it was untimely and without integrity. Again, the FDA should have a greater role in recalls, including a registry to identify failures and more authority to prevent Sulzer’s poor handling of its recall and any future recalls.
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