Blaž, a Prisoner of the Medical Devices Industry
The baclofen pump implanted under Blaž’s skin stopped working twice in five years, both times due to corrosion. Both times, the staff at the University Rehabilitation Institute Soča (URI Soča) in Ljubljana managed to save his life. SynchroMed II pumps have been the subject of numerous recalls, adverse events, court orders, and lawsuits. They also already killed.
Blaž was born prematurely, making him susceptible to cerebral palsy from his very first moments. When he was ten years old, he received his first implant: a baclofen pump at the Children’s Hospital of Pittsburgh in the United States. His parents took him there because the condition required an extremely demanding and risky procedure.
A renown neurosurgeon, A. Leland Albright, who developed the use of intrathecal baclofen to treat children with spasticity in the early 1990s, performed the operation.
Baclofen is used to relieve spasticity. It is sometimes given orally in either tablet or liquid form. But in cases of severe spasticity, when all other measures fail, it can be delivered intrathecally, that is, directly into the spinal canal.
Blaž needs baclofen to be independent within the constraints that bind him to his wheelchair and the assistance of his family. He controls the wheelchair with a steering system developed by his father Igor and friends. Both names are pseudonyms, not disclosed to protect the family’s right to privacy.
He controls the steering system by pressing his tongue on “keys” fitted to his teeth. In this manner he also controls other devices that are not affected by his lack of control and involuntary head movements — such as the computer.
Blaž really likes to play computer games. Through simulations of airplanes, motorbikes, or cars, he tries to catch hold of the untouchable world. To be able to do all this, he needs baclofen to be steadily delivered into his nervous system. The pump is programmable and allows the medicine to be dosed with the utmost precision.
A series of adverse events ... And then a decree
The SynchroMed II pump currently implanted in Blaž is already his fifth one. When he received the first one, his mother and father were ecstatic. All of a sudden they could put their son in an armchair, where he could sit without any help. Their sleep also improved because taking shifts to get up during the night was no longer necessary.
“Due to reduced spasticity, greater mobility and reduced pain, the general quality of life is improved in the majority of patients with very pronounced spasticity,” explained the head of the rehabilitation department at URI, Soča Grabljevec, in an article intended for both the scientific and general public.
But their happiness was short-lived. After about a month, the area where Blaž’s pump was implanted became inflamed and he developed a serious infection. The pump was removed in an emergency intervention and three months of recovery followed. Doctors told his parents that they should wait some time before trying again, because a new version was expected on the market within a year.
In 2003, Blaž got a new pump, then another in 2008. The last one suddenly stopped working five years later, in 2013. When examining the pump after this complication, doctors discovered traces of humidity under the cover, which had caused corrosion. Documents we had access to show that the gears were completely corroded.
Five years later, this June, Blaž’s parents woke to another nightmare as their son’s pump stopped working. Luckily, a team at URI Soča that provides 24/7 emergency service for patients like Blaž gathered within an hour to save him. Igor, Blaž’s father, has nothing but praise for his son’s medical team.
At URI Soča, logged six adverse events with the SynchroMed II pump in the last five years have been logged: two in 2013, one last year, and three this year. As stipulated by law, all these adverse events were reported within 24 hours to the Agency for Medicinal Products and Medical Devices (JAZMP) and to Zaloker & Zaloker company, the supplier of the pumps. The supplier also reported to JAZMP.
The adverse events were the same as those that have been occurring with these pumps practically the whole time they have been on the market. The incidents have been discussed in national and foreign literature, scientific, as well as popular. The SynchroMed II can over- or under-dose the drug or suddenly stop working. According to professional estimates, the risk for adverse events with theses pumps amounts to between 1 and 2 percent, while “life-threatening adverse events are substantially rarer.”
As recorded in the Medical Device Recalls database maintained by the U.S. Food and Drug Administration (FDA), various pump series and lot numbers were recalled at least 71 times since 2004.
There is no such data for Europe since presently no one in the EU collects information on adverse events in a single place, as revealed by journalists as part of the Implant Files project.
As much as 41 of these recalls were of Class I, which according to U.S. standards means that they involved “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
The last recall happened this March, and it is worth bearing in mind that a recall of a certain pump series does not necessarily mean a recall of an entire series. Only specific ID numbers of devices within a series can be recalled. Manufacturers’ recall notices specify whether a given recall applies to an entire series or just individual identification numbers.
More than eight million documents and numerous databases collected and examined by journalists of the Implant Files project, in which Oštro participated, also contain data on lawsuits concerning adverse events that involved the SynchroMed II pump. Among these cases, at least one concerns a death purportedly caused by this pump.
In the U.S., these pumps were linked to 800 deaths and 35,000 injuries in the last decade. In Canada, they allegedly caused 12 deaths and 104 injuries since 2016. We also found academic articles that discussed corrosion in these pumps even before the serious adverse events experienced by Blaž.
Behemoth’s negligent manufacture
The pump is produced by Medtronic, one of the largest manufacturers of medical devices in the world. In 2008, the corporation paid the U.S. Department of Justice $75 million (€66 million) to settle claims it defrauded government health programs. Ten years later, Medtronic generates at least $30 billion (€26,4 billion) in annual revenues. The company has developed hundreds of products and opened branch offices in 160 countries.
According to journalists’ calculations based on the FDA data, Medtronic’s products have been linked to no fewer than 292,000 injuries and 9,300 deaths over those ten years. Last year, one out of five adverse event reports involved Medtronic’s products, a rate twice as high as its rivals.
Over this same decade, Medtronic’s annual reports show that the company spent $3.2 billion to settle about 20,000 claims and lawsuits from patients.
In a statement for ICIJ, Medtronic’s spokesman Rob Clark stressed that the company has an extraordinary safety system and continuously monitors products before and after they are confirmed as safe for use on patients by regulators. But Clark also said that all medical devices – regardless of how well they are designed and how thoroughly they are tested – entail a risk.
The FDA kept adverse events involving the SynchroMed II pump under close scrutiny for around six years. It warned Medtronic that it was violating good manufacturing practices and demanded corrective measures, but to no avail.
The company’s relationship with the regulator deteriorated to such an extent that the FDA did something almost unheard of: it filed a consent decree against Medtronic, accusing the corporation of negligent manufacturing of pumps.
The dispute ended two years later when Medtronic signed a consent decree stating that it would not market or sell SynchroMed II pumps until the issues were resolved. It could only sell the pumps in most urgent cases under the condition that an approved form confirming medical urgency was submitted.
Since last September, Medtronic has been able to sell its pumps without. It must, however, undergo independent revisions until 2020 and is obliged to submit revision reports to the FDA. This year, the FDA has already approved a new version of the SynchroMed II pump that displays operation data to patients on tablet computers.
Though the situation for patients who use the SynchroMed II pump with baclofen (or morphine, which is also allowed) is alarming, there have been no real alternatives until this summer.
In cases as severe as Blaž’s, doses of baclofen 100 times greater must be used when the drug is administered in tablet form to ensure that a sufficient amount enters the spinal canal. Due to Blaž’s condition it is much more reliable for him to be administered baclofen intrathecally, that is directly into the spinal canal.
Since Blaž first received an implant, two other programmable pumps have come on the market – Codman from Johnson & Johnson and Prometra from Flowonix Medical. The staff at URI Soča wanted to experimentally implant the Codman pump, but Johnson & Johnson withdrew it from the market before the procedure. And Prometra is not compatible with MRI scans, which must be used on patients like Blaž.
This summer, the Siromedes pump by a German manufacturer called Tricumed came on the European market, making for a possible alternative. But, as Dr. Klemen Grabljevec, the head of the rehabilitation department at URI Soča, explains, so far only 250 of these pumps have been implanted in the EU.
“We treat spasticity with medical methods that are proven to work and based on experience, after carefully examining the advantages and disadvantages of new medical devices and after they are confirmed by the Scientific Council of the URI Soča,” he explained, adding that doctors at URI hospital do not yet know whether they will test the Siromedes pump.
URI Soča also said that they had not been informed of any recalls of the SynchroMed II pumps in the EU, that they did not have “any reason not to implant this device,” and that they follow an established protocol in case of adverse events. They inform their patients about all the pros and cons of the pump in detail and about how they should proceed in case of complications.
The Slovenian Agency for Medicinal Products and Medical Devices confirmed that it knows about the manufacturer’s corrective actions, also regarding the [pump] recall you mentioned. “The manufacturer informed its distributors and end buyers (health care personnel that uses the devices concerned) about its safety corrective actions,” the agency stated in its response to Oštro.
Medtronic gives its own version of truth
A year ago, Medtronic’s Croatian partner, Fabrio Pharma, asked the Slovenian Medical Ethics Committee to carry out clinical research on the safety and operation of the SynchroMed II system. The study would be implemented in several EU countries, including Slovenia, and be led by Grabljevec.
The committee granted the necessary approval to Medtronic at the end of last December. This June, when Blaž experienced his second serious complication with the pump, the Croatian representative sent an additional document to the committee. The patient consent form had to be harmonised with the EU General Data Protection Regulation (GDPR).
The committee assessed the form as compliant. It also addressed to Medtronic “an additional question concerning the finding that some of the pump model numbers were recalled and that the documentation did not specify which model numbers will be used in the Republic of Slovenia.”
At the end of July, the committee asked Grabljevec, for an explanation, which was delivered verbally in August. Grabljevec explained to Oštro that he informed the president of the committee, Božidar Voljč, over the phone that, as far as the Soča institute knew, the pumps intended to be implanted in Slovenian patients were not a subject of a recall.
“If we were aware of the fact that certain pump series are to be recalled, we would not be implanting them in patients, because our main professional guideline is to ensure patient’s safety and well-being,” Grabljevec told Oštro.
The Medtronic office in Switzerland also sent their explanation, and the Slovenian Medical Ethics Committee gave the green light for the research. But what Cedric Gaumet, senior regulatory affairs specialist at Medtronic, sent to the Slovenian committee was only a half-truth.
“The SynchroMed II pump was not a subject of recall in accordance with the recent approval decision issued by the FDA. No pump was withdrawn from the market neither in the U.S. nor Europe,” Gaumet wrote on July 30.
According to FDA data, since April 2015 when Medtronic signed a consent decree, SynchroMed II pumps were recalled no less than six times, including one case of a Class I recall.
Medtronic’s statement, taken literally, is indeed true because FDA did not demand from the corporation to recall the pumps. In general, however, Medtronic was being economical with the truth.
We asked for explanation from Medtronic Adriatic, which also covers Slovenia, but instead received a reply from their Danish office. Marianne Reedtz Sparrevohn, director of corporate communications at Medtronic, declined our request for explanations three times.
She suggested that we contact ICIJ and send questions to Medtronic through them. At that time, though, the corporation sent a second stack of answers to ICIJ, adding that it refuses to answer any more questions.
We also tried to contact the Croatian company Fabrio Pharm, which applied the clinical research in the name of Medtronic. The result was the same.
I did, however, receive a call from a Croatian-speaking stranger whose name was Hrvoje.
He asked: “Is that you, Nataša?”
I replied that I was not.
“You are not Nataša from Medtronic?!”
I replied: “No, I’m a journalist investigating Medtronic.”
“Oh, wrong number then.”