Medical Device Recalls may not rake up high numbers as other consumer products do, but the pain people go through before and during the recall process makes them one of the most important product recalls. But tracking has been the major issue over the years as many devices, most of them implants, being untraceable once inside the human body. People literally live entire lives with these defective devices in them as their bodies creak and moan.
With most implants carrying some sort of sensor or electronic components these days, the risk of them failing and the newly emerging software threats have been a growing concern in the recent years. The below list shows some of the high-profile device recalls in the modern medical history.
1. Sulzer – hip Replacement Recalls
Ta The 80’s and 90’s was the era of increasing bone replacements such as artificial knee and hip joints. Suzler Medica, a Swiss based company and the leading medical device manufacturer in the European Union in the period was providing Hip and knee replacement devices, predominantly to the US during the late 90’s. They had a manufacturing process outsourced, which they later decided to do in-house. This is where the problem started as they decided to skip an acid bath process considering the material used being Titanium, a corrosion free substance. This move though had unforeseen effects as a previously undetected mineral oil spillage trace which the acid bath had neutralised, had been left with the implants, causing improper fitting in patients.
The result was nearly 40,000 defective implants, which were recalled, 26,000 of them already implanted. More than 1000 law suits and nearly 4000 corrective surgeries later, the final costs for settling the lawsuits was $700mn. The problem though, did not end there. The corrective surgeries were to be tracked and carried out, implants yet to undergo corrective surgeries had to be monitored while individual settlements had to be carried out- all of which had to be done by setting up a trust. This does not count the lost trust as well as extra scrutiny in the future by the administrators! This case is a classic example reiterating the difficulties in altering the manufacturing process and also the testing inadequacies relating to such high value products.
2. Johnson & Johnson Hip Replacement
This is another case of Hip Replacement, this time involving one of the giants in the Industry – J&J. DePuy (a subsidiary of J&J) introduced its all metal variant of the replacements in the early 2000’s. The product was available throughout the world, with the majority being in the US. After having implanted nearly 93,000 of them, J&J found these implants had a serious design flaw, causing metals to abrade and corrode and releasing components of cobalt and chromium into the bloodstream. The recall finally happened in 2010. Though uncertain, this product is claimed to be the cause of 4 deaths in India.
In 2013, 3 years after the recall, the firm had to settle $2.3bn for lawsuits in the US in addition to launching a trust to help the affected. The issue is yet to reach a conclusion as thousands of lawsuits are pending and in several countries including India, where a helpline has been created at the direction of the government while a committee report to the government has recommended a Rs. 20 lakh pay-out to the affected. The key reason behind this recall is the design flaw and the controversial practice of constant monitoring of products only after the launch, leading to recalls in case of failure. Today’s advances in Simulations must reduce such incidents to a greater extent in the future.