Thousands of Patients Under Observation in Faulty Implant Scandal

For several months, a public hospital in the Catalan city of Reus, Spain, used defective or expired surgical orthopedic implants after administrators were pressured by city officials to buy their supplies from a local provider called Traiber, a law enforcement investigation has found.

Now, after reviewing 1,700 cases at Sant Joan de Reus Hospital, doctors have called in 250 patients and ordered new surgeries for at least 20 of them in order to extract the faulty items.

Meanwhile, nearly 6,000 patients throughout Spain who are walking around with Traiber knee, hip and backbone implants are being observed, according to the head of the Spanish Medicine and Health Product Agency (AEMPS), Belén Crespo.

Nearly half of these are in Catalonia, while many others live in the Valencia, Madrid and Galicia regions, according to Traiber. Because the company worked with several distributors, however, their products infiltrated all of Spain.

Crespo, though, has been trying to convey a message of calm, telling Spanish media: “The problems involve the company’s last few months of activity, in 2014, until our November 7 alert. Until recently, Traiber had all necessary permits and licenses, so the vast majority of patients can rest assured that they have quality implants.”

The case first came to the attention of the authorities in October of last year, when Traiber employees decided to file a complaint against their own bosses after hearing about people experiencing intense pain following surgeries.

The AEMPS informed the Catalan health department, which issued a warning and alerted prosecutors. This led to a court investigation and the arrest of the deputy mayor of Reus, Teresa Gomis, of the ruling nationalist party Convergència i Unió (CiU).

The Reus court is also investigating why doctors did not immediately inform health authorities after operating on a patient in May 2014 and finding a badly damaged Traiber knee implant just six weeks after it had been implanted. “When they cut the knee open, the orthopedic surgeons found that the white polyethylene piece implanted just weeks earlier was highly deteriorated and yellowish,” former Traiber employees said. The failure to report the case potentially put an untold number of patients at risk.

The April 28 arrest of Gomis and of Traiber owner Lluís Márquez was the climax of an investigation that began six months earlier, when the AEMPS ordered a recall of all Traiber products after they were found to be “made without a license” and lacking the CE conformity marking, which symbolizes that a product meets European requirements. This, said the agency, posed “a serious risk to patients’ health.”

Spanish newspaper El Pais learned that it was Traiber’s own employees who reported the situation to the Spanish health agency.

“The company heads had crossed all ethical and legal limits,” said several former workers on condition of anonymity.

Sant Joan began buying from Traiber again in early 2014. The health alert was issued in November. The investigation is likely to be lengthy, as the AEMPS does not even know how many illegal products may have been sold “due to the irregularities in the company’s quality controls.”

Court papers released by the Reus judge investigating the defective orthopedic equipment used at a local hospital indicate that Márquez enjoyed favors from Gomis, El Pais reported.