A lawsuit was filed on Nov. 7 on behalf of 25 patients who had ceramic-coated B. Braun artificial knees implanted. In the filing, the plaintiffs accuse the medical device manufacturer of deliberately concealing the long track record of failures the product had when marketing it to surgeons.
The plaintiffs also accuse the company of having hoodwinked the Food and Drug Administration (FDA) into believing that the device was equally safe to similar devices on the market -- an assertion that fast-tracked their approval of it. They also claim that the company failed to make the FDA aware of the product's failures on countless occasions.
B. Braun's and its subsidiary Aesculap Implant Systems are described as long having championed its ceramic implants as being far superior to metal implants on the market. B. Braun would reportedly tell surgeons that its device's advanced surface was created to last longer than other replacement joints on the market.
The plaintiffs assert that the device was far from being effective, though. Many patients experienced situations where the bonding cement failed to properly adhere to their bones as intended. In those cases, their surgeons determined that moisture had collected in between the patients' tibias or femurs and the device. This caused them to become dislodged.
The lawsuit chronicles how doctors removing the affected patients' implants didn't need to follow the typical protocol of sawing through cement to remove the device. Instead, they needed only to strike the implant with one tap of a mallet to release it by hand.
The lawsuit also chronicles how doctors, who informed B. Braun of the device's poor adhesion, were given excuses for why the device failed. They were reportedly told that this was because of their own poor application of the cement, because poor quality bonding cement was used or because antibiotics broke it down.
Although the patients affected by this faulty medical device hail from at least 10 different states, including Texas, the lawsuit was filed in California where the surgeries initially took place and where revisions will be made.
If your medical condition declined after you were implanted with what's now known to be a defective medical device, a Houston personal injury attorney can advise you of your legal options.
Source: The Morning Call, "Patients sue B. Braun alleging defect in replacement knees," Peter Hall, Nov. 07, 2017