COLUMBIA, South Carolina – Desperate after years of anxiety, Jim Taft listened carefully when his pain doctor described a medical device that could change his life.

This would not repair the nerve damage to the mutilated right arm, Taft and his wife remember saying the doctor, but a spinal cord stimulator will conceal his pain, making it "like new."

Taft's pacemaker failed shortly after his surgical implantation. After an operation to fix it, he said, the device electrocuted him so many times that he could no longer sleep and even fell down a staircase. Today, Taft, 45, is virtually paralyzed, a prisoner in his own bed, barely able to get to the bathroom alone.

"I thought I had a wonderful life," said Taft. "But look at me."

For years, medical device manufacturers and doctors have introduced spinal cord stimulators as a cure-all for millions of patients suffering from a wide range of painful pain disorders, making them the most effective choice. one of the fastest growing products in the medical device industry. Businesses and physicians are aggressively supporting them as an antidote to the deadly opioid crisis in the United States and as a cure for an aging population in need of chronic pain relief.

But pacemakers – devices that use electrical currents to block pain signals before reaching the brain – are more dangerous than many patients know, an Associated Press investigation reveals. They represent the third largest number of reports of medical device injuries to the US Food and Drug Administration, with more than 80,000 incidents reported since 2008.

Patients report being shocked or burned or have suffered nerve damage to the spinal cord ranging from muscle weakness to paraplegia, according to FDA data. Of the 4,000 types of devices monitored by the FDA, only metal hip prostheses and insulin pumps recorded more injury reports.

FDA data contain more than 500 reports of spinal cord stimulator deaths, but details are scarce, making it difficult to determine whether deaths were related to the pacemaker or implant surgery.

Medical equipment manufacturers insist that spinal cord stimulators are safe – about 60,000 people are implanted every year – and surgeon doctors say they have helped reduce the pain felt by many of their patients.

Most of these devices have been approved by the FDA with few clinical trials, however, and the agency data show that spinal cord stimulators have a disproportionate number of injuries compared to the implants of the spinal cord. the hip, which are much more numerous.

The AP released a report on vertebral pacemakers as part of a joint year-long investigation into the global medical device industry, which included NBC, the International Consortium of Investigative Journalists and more than 50 other media partners from around the world. The reporters collected and analyzed millions of medical records, recall notices, and other product safety warnings, in addition to interviewing doctors, patients, researchers, and researchers. business alert launchers.

Media partners have found that, regardless of the type of medical equipment used, more than 1.7 million injuries and nearly 83,000 deaths have been reported to the FDA over the last ten years.

The survey also found that the FDA – considered by other countries as the gold standard for surveillance of medical devices – puts people at risk by adopting an abbreviated approval process and then reacts slowly by forcing companies sometimes correcting deadly threats. some products.

The devices are rarely removed from the market, even in case of major problems. And the FDA does not disclose the number of devices implanted in the United States each year – essential information that can be used to calculate success and failure rates.

The FDA recognizes that there are limitations to its data, including errors, omissions, and under-reporting that can make it difficult to determine whether a device has directly caused injury or death. But he rejects any suggestion of failure of supervision.

"There are over 190,000 different devices on the US market, and we approve or remove about a dozen new or modified devices every business day," said Dr. Jeffrey Shuren, director of medical devices for the FDA. may. "The number of devices that get attention at all times in the press is less than what we could put on the market in a single business day, but that does not mean the system fails. is remarkable that the system works as it does. "

In response to reporters' questions, the FDA said last week that it was taking further steps to create "a stronger medical device safety net for patients through better data". "Unfortunately, the FDA can not always know the scale of the benefits and risks of a device before it is marketed," the agency said. Over the last 50 years, the medical device industry has revolutionized the treatment of some of the most deadly scourges of modern medicine, introducing devices to treat or diagnose heart disease, cancer and diabetes.

Pete Corby, who suffered a back injury while working as a movie stuntman, said a spinal cord stimulator helped him cope with his constant pain and stop taking opioids he became addicted to .

"It's the biggest thing that saved my life, literally, saved my life," said Corby, estimating that up to three quarters of her initial pain had been relieved by the pacemaker.

Medical device companies have "invested countless resources – both human and financial – into the development of leading-edge compliance programs," said Janet Trunzo, Chief Technology and Regulatory Affairs Officer at AdvaMed. main professional association of the sector.

At the same time, medical device manufacturers have also spent billions trying to influence regulators, hospitals and doctors.

In the United States, where drug and device manufacturers are required to disclose their payments to physicians, the 10 largest medical device companies paid nearly $ 600 million to doctors or their hospitals to cover the fees of doctors. consulting, research, travel and entertainment expenses, according to an expert and analysis ICIJ data from the Centers for Medicare & Medicaid Services. This figure does not include payments from device manufacturers such as Johnson & Johnson and Allergan, who also sell other products.

In addition, lobbying records show that the top four manufacturers of spinal cord stimulators have spent more than $ 22 million combined since 2017 to try to influence the legislation that benefits their overall business. , which includes other devices.

Investigations have revealed that some companies have been fined for bribing doctors, illegally promoting products for unapproved purposes, and paying for studies that proclaim the safety and efficacy of their products. .

In a 2016 case, Olympus Corp. of the Americas, the largest US distributor of endoscopes and related medical equipment, agreed to pay $ 623.2 million "to resolve criminal charges and civil actions related to a ploy to pay rebates to doctors and hospitals ". to the US Department of Justice. Olympus said it has "agreed to make various improvements to its compliance program."

In a previous year's case involving spinal cord stimulators, Medtronic Inc. agreed to pay $ 2.8 million to settle the litigation of the Department of Justice, claiming that the company had harmed patients and defrauded federal health care programs by providing doctors with "powerful" financial incentives that turned them into "sellers" for costly procedures Medtronic denied wrongdoing. "Medtronic generally does not comment on a specific dispute, "said the company in a statement." We are convinced of the safety and effectiveness of our spinal cord stimulators and the tremendous benefits this technology provides to patients, many of whom have tried all other treatment options without any benefit. "

Some doctors enthusiastically promote spinal cord stimulators without revealing to their patients that they have received money from medical device manufacturers. Some experts say that physicians are not legally required to disclose such payments, but that they have an ethical obligation to do so. Sometimes money goes to doctors' hospitals, not directly to them.

As for Taft, he said that he only wanted to get better, but he lost hope.

"It's my death sentence," Taft said, lying under the wooden headboard of his bed on which he engraved the words "death row".

"I'm going to die here," he says.

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A generation ago, tens of thousands of women were injured by the Dalkon Shield, an intrauterine device that caused life-threatening infections. Consumer advocates demanded that medical devices be tested and pre-market approved to prevent death and injury from defective products.

Thus, in 1976, Congress passed the Medical Device Amendments, a law designed to assure Americans that devices recommended by their doctors would do good and not damage.

"Until today, the American consumer could not be sure that a medical device used by his doctor, his hospital or himself was as safe and effective as it could have been. or should be, "said President Gerald Ford enacting the law.

In charge of enforcing the law, the FDA has created three classes of medical devices. High-risk products such as spinal cord stimulators are designed to meet the highest standards of clinical testing. However, the vast majority of devices are subject to a less rigorous review process, which facilitates the placing on the market of devices deemed "substantially equivalent" to products whose use has already been approved.

As conceived by Congress, this process should have been eliminated. Instead, it has become the standard pathway on the market for thousands of devices, including hip prostheses implanted in tens of thousands of patients, which will be recalled later because the metal chips of the devices have made some people sick.

The AP found that the FDA had allowed some spinal cord stimulators to reach the market without new clinical studies and had largely approved them based on the results of studies conducted on previous vertebral pacemakers.

Spinal stimulators are complex devices that send electrical currents through wires placed along the spine, with the help of a battery implanted under the skin. An external remote control controls the device.

The four largest manufacturers of spinal cord stimulators are Boston Scientific Corp., based in Marlborough, Massachusetts; Medtronic, headquartered in Ireland and the United States; Nevro, Redwood City, California; and Illinois-based Abbott, which entered the market after buying $ 23.6 billion from St Jude Medical Inc.

St. Jude's request to market its first spinal stimulator did not contain any original data on the patient and was based on the clinical findings of other studies, while Boston Scientific's request for its Precision pacemaker Spinal cord was largely based on older data, although it included a small, original study of 26 patients followed for as little as two weeks.

Once approved, medical device manufacturers can use countless additional requests to modify their products, even when the changes are substantial.

For example, only six new spinal cord stimulators have been approved since 1984, and an additional 835 modifications were made to these devices given the green light in the middle of this year, the AP revealed. Medtronic alone has granted 394 additional modifications to its pacemaker since 1984, ranging from changing the sterilization process to updating the design.

"It's a little history of the FDA's regulation of devices, which just puts products on the market," said Diana Zuckerman, president of the National Center for Health Research, which studies medical devices for almost 30 years.

Medical device manufacturers have cited numerous industry-funded studies showing the effectiveness of spinal cord stimulation in the treatment of chronic pain. Experts say the treatment is considered effective if the pain is at least halved, but not all patients experience as much pain reduction.

A 2016 study of different stimulation systems found "significant evidence" that it was "safe, clinical and cost-effective treatment for many chronic pain states".

But Zuckerman pointed out that the most thorough studies have taken place after the devices have been widely used on people.

"These patients are guinea pigs," she said.

The FDA stated in a statement that it approved, authorized or granted marketing approval for an average of 12 devices per business day and that its decisions were "based on sound scientific evidence" that the devices were safe and effective.

Dr. Walter J. Koroshetz, Director of the Division of Neurological Disorders and Stroke at the National Institutes of Health, said that tests involving medical devices such as spinal cord stimulators are usually small and sponsored by Industry, with a "substantial" placebo effect.

"I do not know anyone who is satisfied with the current technology of the spinal cord," Koroshetz said. "I think everyone thinks it can be better."

___

Whenever Jim Taft showed up in his doctor's office of pain management, he peeked at pamphlets touting spinal cord stimulators – those with pictures of people swimming, bike and fishing.

In the examination room, said Taft, his doctor told him that the device had been effective for his other patients and that it would improve his quality of life.

After being wounded in the right arm while transporting materials for an architectural engineering firm, Taft had been seeing the doctor for five years before deciding to procure a pacemaker in 2014. What l? He finally influenced, he said, is the doctor's plan to wean him off painkillers.

"I felt stuck in a corner," said Taft, who lives in West Columbia, South Carolina.

Taft said his doctor relieved the technology, noting that pacemakers had improved the quality of life for his patients. But four years later, Taft is unable to walk more than a few steps.

Taft is one of 40 patients interviewed by the AP who reported having had problems with spinal cord stimulators. The AP found them on online forums for people with medical devices. Twenty-eight of them reported that their spinal stimulators not only failed to relieve pain, but were worse off than before their surgeries.

Zuckerman, who worked for the US Department of Health and Human Services and as senior policy advisor for First Lady Hillary Rodham Clinton, said that no doctor wanted to think that it was harming patients.

"But there is a huge financial incentive to minimize, ignore or forget the bad experiences of patients and focus only on the degree of patient satisfaction," she said.

More than half of the patients surveyed by the AP said they felt compelled to buy pacemakers for fear of having their doctors cut off their pain medications – the only thing that helped them.

Pacemakers are considered a "last resort" treatment by insurance companies, as well as by Medicare and Medicaid. This means that doctors must follow a protocol before insurance pays for the device and implantation.

Physicians must demonstrate that conservative treatments have not helped and that patients also undergo psychological assessments to assess their chances of success. They then undergo a trial period of three days to a week with thin electrodes inserted under the skin. If patients claim that the external transmitter has been relieved by sending electrical impulses to contacts near their spine, they must undergo surgery to implant a permanent pacemaker.

Taft said his three-day trial helped reduce his pain. Thus, a few days before his operation, he began to prepare for a new life. He ordered Lumber to renovate a patio and deck for his wife, Renee, in gratitude for her years of support.

In April 2014, Jason Highsmith, a neurosurgeon from Charleston, South Carolina, implanted the Boston Scientific Precision pacemaker in Taft. He has received $ 181,000 from the company over the last five years, in the form of consulting fees and payment of travel and entertainment expenses. A sales representative from Boston Scientific was in the operating room – a common practice, according to the AP.

Highsmith would not comment on the payments. Other doctors have defended this practice, claiming that they perform important work that helps companies – and ultimately patients – and that they deserve to be paid for their time .

From the moment Taft was opened and the device was placed in his body, he had only problems, according to hundreds of pages of medical records reviewed by the AP. The camera began to shock him randomly and the battery burned his skin.

Taft and his wife complained repeatedly, but his doctors and a Boston Scientific representative told them that the spinal cord stimulators did not cause the kind of problems that he had.

This goes against Boston Scientific's own literature, which recognizes that spinal stimulators and procedures for implanting them involve risks such as shunt displacement, over-stimulation, paralysis, and infections.

This was also not considered in the PA's analysis of FDA-reported injury reports, which found that shocks and burns were reported for all major marrow pacemaker models. spinal. For Boston Scientific devices, infection was the most common complaint in the past decade, reported in more than 4,000 reports of injuries.

In response to questions, the company described the infection as "risk, unfortunately, for any surgical procedure" for which the company strives to avoid any risk. He added that FDA data "should not be interpreted as a causal sign of a problem with our device." In fact, many examples of reportable infections include those that have been caused by the surgical procedure or postoperative care ".

"In our internal quality assessments, more than 95% of the injury reports were temporary or reversible," the company added.

Taft said that had he known that the gear was hurting so many people, he would have reconsidered buying one. A sales representative from Boston Scientific tried to reprogram the device, but nothing worked.

"I told them that I had the impression that lead was coming up and down in my spine," Taft said. "They said," It can not move. " But in July 2014, X-rays revealed that the advance had moved well – two inches apart.

Highsmith told AP that the electrode had ceased physical activity, although Taft stated that it would not have been possible due to his condition. Taft said that he was so sick after his operation that he was never able to redo the patio and deck for his wife or do anything else vigorous.

In October, Highsmith said he used Taft to install a new probe, test the battery and put it back in place.

Nevertheless, Taft's medical records show that he continued to report numbness, tingling, and pain. At a January 2015 appointment, a medical assistant wrote that the device "seemed to make her pain worse".

The pacemaker was removed surgically in August 2015. The following June, Taft received a second opinion from a clinic specializing in spinal injuries, which stated that he was suffering from "axial pain and significant lumbar spasms due to implantation and explantation of the pacemaker.

Highsmith stated that other doctors have documented severe arthritis in Taft and that, even though he has not examined Taft for more than three years, it is "likely that his current condition results from the evolution of the disease and other factors ".

He did not answer the question of knowing he had informed Taft of the risks associated with pacemakers.

The doctor said the overwhelming majority of his spinal cord stimulator patients had significant pain relief.

"Unfortunately, despite the major medical advances made with devices of this type, some patients still suffer from incurable pain," he said.

Renee Taft, a legal assistant, contacted Boston Scientific in 2017, but said the company had refused to help her because her husband 's pacemaker had been removed and accused Taft of her problems, adding that "I have not heard from you. he had engaged in "rigorous physical activity" after the surgery.

In the letter from the company's legal department, Boston Scientific also stated that federal law protects manufacturers against personal liability claims involving FDA-approved medical devices.

In response to questions from the AP, Boston Scientific again blamed Taft's "level of activity" but did not elaborate. The company also said that other factors could contribute to its problems, such as "hyperalgesia, a phenomenon associated with prolonged use of opioids, which makes patients more and more sensitive to certain stimuli ".

Brenda Simpson-Davis of Milton, Florida, said that Boston Scientific did not consider her complaints after her husband had suffered a life-threatening infection after a surgery. ;implant.

George Davis, 57, had three Medtronic spinal cord implants between 2003 and 2007 after a car accident that mutilated his back. They have temporarily reduced some of his pain, but he said that non-rechargeable batteries meant to last for years had never done so and that he was tired of the many surgical moves.

In 2015, his doctor specializing in pain management advised him to try the Boston Scientific Precision Spectra, which he described as the best on the market. Unlike older Davis models, there was a rechargeable battery.

A few weeks after his surgery, Davis said, he began to experience back and leg pain and a burning sensation at the implant site. After her skin began to darken, the doctor performed an emergency operation to remove the device.

Months later, Davis reluctantly agreed when his doctor urged him to try another Boston Scientific model, but found the device even worse.

The following year, he spent more than 100 days in hospitals fighting a life-threatening infection. Today, Davis says he's struggling to get up from bed.

Boston Scientific stated that she had never received stimulators implanted at Taft and Davis, so she could not "conclusively identify" the causes of their problems. "Many factors can contribute to the persistent symptoms of a patient, ranging from increased physical activity to the onset of pain in other areas," the company said.

Simpson-Davis said he spoke to lawyers all over the country, who warned him against the very high bar for a lawsuit. Finally, she found a Texas lawyer who said he would consider taking the case if she could find two more dozens of potential plaintiffs.

"For me, it is not money, but people – it is knowing what they are getting into," she said.

___

For years, Valerie McJunkin had sought relief from a rare neurological disorder that made her feel like her legs and feet were on fire. So, when a sales representative of a medical equipment company and his West Virginia pain management physician recommended to him what seemed to him to be a "miracle device", she was all to made comfortable.

They said that a new type of pacemaker – one that targeted a group of sensory nerve cells in the lower back – was preferable to a device for the spinal cord. She just needed to stand trial for a week.

When McJunkin arrived at the Pain Clinic last January for the trial, Abbott's Sales Representative was present with her doctor and staff. They explained each detail. This device did not suit everyone, but she was the ideal candidate, she recalls.

Over the next week, they called or texted her almost every day to see if the pacemaker alleviated her ordeal. And as the trial seemed to help, she continued with the implant.

A few days later, the camera began to shock her randomly – an acute pain that looked like a lightning bolt.

When McJunkin called her doctor and Abbott's representative, she said that they had hinted that she was at fault because "pacemakers do not do that". It was not until she received a certified letter from Abbott in March that she learned that it was not in her head: the company stated that her device had been recalled by her device because of a glitch that could cause "discomfort" to patients.

Since 2005, there have been 50 recalls involving spinal stimulators, an average of four per year over the last five years. Environ la moitié des rappels concernaient des stimulateurs fabriqués par Medtronic, le plus grand fabricant mondial d’appareils, bien qu'aucun d’entre eux ne soit prévenu du risque de blessure grave ou de mort.

Au début du mois de septembre, McJunkin a invité un journaliste de l'AP à l'accompagner lorsqu'elle a rencontré son médecin et le représentant des ventes de la société pour demander le retrait du dispositif.

Le vendeur Abbott et son médecin lui ont suggéré de prendre un autre stimulateur, affirmant qu'elle était à court d'options, en particulier parce que son médecin ne pouvait pas prescrire d'opioïdes en raison de la répression exercée par le gouvernement. Si elle n'a pas eu un autre stimulateur, a-t-il dit, elle a vécu toute une vie de douleur. Il n'a pas suggéré d'autres options, telles que des injections de stéroïdes ou une thérapie physique continue.

"Je n'essaye pas de vous forcer l'esprit", dit le docteur. "Mais pour moi, est-ce que je voudrais vivre ma vie comme ça? … Si je reçois cette nouvelle batterie et que cela aide totalement, cela change ma vie de 180 degrés, d'accord? Mais si je ne le savais pas déjà, je sais déjà ce qui va se passer arrive à moi: je vais souffrir pour le reste de ma vie ".

En rentrant chez elle à Martinsburg, en Virginie occidentale, McJunkin a agrippé le volant de sa voiture, son tatouage portant la mention "persévère" visible sur son avant-bras.

"Vous faites confiance à votre médecin. Vous pensez qu'il va faire la bonne chose", dit-elle. Elle fit une pause, retenant ses larmes. "Je voulais juste vivre sans douleur. Mais maintenant, cet espoir est parti."

Fin octobre, son médecin a retiré l'appareil.

L'expérience de presque tous les 40 patients interrogés par l'AP reflétait celle de McJunkin: leur douleur avait été réduite au cours de l'essai mais était revenue une fois que leurs stimulateurs avaient été implantés.

Selon les experts, la réponse pourrait être un effet placebo créé lors de l’essai durant l’essai, selon lequel seul le stimulateur peut soulager la douleur, exacerbé par les patients qui ne veulent pas décevoir les membres de leur famille, qui ont souvent été leurs aidants naturels.

"Si les patients savent qu'il s'agit d'un dernier recours, d'un dernier espoir, ils répondront bien, a déclaré le Dr Michael Gofeld, anesthésiologiste et spécialiste de la gestion de la douleur basé à Toronto, qui a étudié et implanté des stimulateurs de la moelle épinière aux États-Unis. et le Canada.

À la fin du procès, le patient "vole haut, les niveaux d'endorphines sont élevés", a déclaré Gofeld.

Les représentants des fabricants sont fortement impliqués tout au long du processus. En plus d'être souvent au bloc opératoire pendant une intervention chirurgicale au cas où le médecin aurait des questions, ils rencontrent les patients pour programmer les appareils dans les semaines suivant l'opération.

La plupart des patients interrogés par l'AP ont déclaré que les réglages de leurs appareils avaient été effectués par des représentants des ventes, souvent en l'absence de médecin ou d'infirmière. Cela inclut un patient qui a été facturé pour la programmation comme si le médecin était dans la salle, bien que ce ne soit pas le cas.

"Les personnes qui vendent l'appareil ne devraient pas être chargées de la maintenance", a déclaré Gofeld. "C'est totalement contraire à l'éthique."

En 2015, au Texas, une ancienne représentante des ventes de Medtronic avait intenté une action en justice en alléguant qu'elle avait été licenciée après s'être plainte que la société avait formé des employés à la programmation de neurostimulateurs en l'absence de médecin. Elle a également affirmé qu'un superviseur de Medtronic lui avait arraché des gants chirurgicaux après avoir refusé de bander une patiente pendant une procédure, l'avait écartée puis nettoyé et soigné la plaie de la patiente. Medtronic a nié les allégations et l'affaire a été réglée à des conditions non divulguées.

Dans l'affaire du ministère de la Justice impliquant Medtronic, un vendeur qui a déclaré gagner jusqu'à 600 000 dollars par an en vendant des stimulateurs de la moelle épinière, a déclaré que les représentants des ventes incitaient les médecins à effectuer des procédures inutiles augmentant les coûts de Medicare et d'autres programmes de santé fédéraux.

"Bien qu'il y ait eu quelques cas où des individus ou des sociétés affiliées ne se sont pas conformés aux politiques de Medtronic, nous avons agi pour remédier à la situation une fois découverte et pour corriger toute inconduite", a déclaré la société.

Gofeld a déclaré croire que les stimulateurs fonctionnaient, mais que bon nombre des problèmes se posaient généralement lorsque les médecins ne choisissaient pas les candidats appropriés. Et il pense que les stimulateurs sont utilisés trop souvent aux États-Unis.

Nevro, l’un des quatre grands fabricants, a indiqué qu’il existait jusqu’à 4 400 établissements aux États-Unis où des dispositifs de stimulation vertébrale sont implantés par divers médecins, notamment des neurochirurgiens, des psychiatres et des spécialistes de la douleur.

C'est une affaire lucrative. Selon les analystes, les stimulateurs et l’opération d’implantation coûtent entre 32 000 et 50 000 dollars, l’appareil constituant entre 20 000 et 25 000 dollars. Si la chirurgie est pratiquée dans un hôpital, le patient passe généralement la nuit et l’hôpital facture des frais d’établissement pour l’obtention du dispositif. Les coûts sont généralement couverts par une assurance.

L’AP a découvert que les médecins pouvaient gagner plus d’argent s’ils effectuaient l’opération dans des centres de chirurgie ambulatoires appartenant à des médecins, car ils achetaient l’appareil, le marquaient et ajoutaient des frais d’établissement.

Au Canada, où Gofeld travaille maintenant, il a déclaré que les chirurgies ne sont effectuées que par des spécialistes des procédures. Il a ajouté que les stimulateurs de la moelle épinière devraient être utilisés au début de la douleur et non après un échec de la chirurgie du dos.

"A ce moment-là," dit-il, "il est trop tard."

___

Alors que les fabricants et les hauts responsables de la FDA vantent les stimulateurs comme une arme dans la lutte contre les opioïdes, les neurochirurgiens comme Steven Falowski sont les évangélistes de première ligne.

"La douleur chronique est l’un des plus gros problèmes de santé que nous ayons aux États-Unis. C’est plus que des maladies cardiaques, le cancer et le diabète combinés", a déclaré Falowski dans une interview.

Il a référé AP à Corby, l'un de ses patients ayant bénéficié d'une intervention chirurgicale et d'un stimulateur de la moelle épinière.

Corby a reçu le dispositif il y a plus de deux ans et affirme qu'après quelques ajustements initiaux, il n'a plus eu de problèmes. Il dit qu'il n'échangerait pas le stimulateur contre des opioïdes.

"En réalité, je les achetais dans la rue … un peu comme une drogue parce que je ne pouvais plus les obtenir" de son médecin antidouleur, a déclaré Corby.

Falowski a déclaré que les opioïdes sont bons pour la douleur aiguë, mais n'ont jamais été conçus pour traiter la douleur chronique à long terme. Pour lui, c'est là qu'interviennent les stimulateurs de la moelle épinière.

S'ils sont utilisés suffisamment tôt pour soulager la douleur, ils peuvent empêcher les personnes de prendre des analgésiques à base d'opium, a déclaré Falowski, qui prend la parole lors de conférences sur la neuromodulation et enseigne aux autres médecins comment implanter des stimulateurs.

Depuis 2013, les fabricants d'appareils ont payé Falowski – ou réseau de santé de l'Université St. Luke à Fountain Hill, en Pennsylvanie, où il travaille – près de 863 000 $, dont 611 000 $ de St. Jude ou de sa nouvelle société mère, Abbott, selon les centres pour l'assurance-maladie et Base de données des services Medicaid. Les paiements vont des frais de consultation aux frais de voyage et de divertissement.

Falowski a déclaré qu'il avait mené des recherches et effectué d'autres travaux pour des fabricants, ajoutant: "Les contrats avec l'industrie sont conclus avec mon hôpital et non avec moi."

St. Luke's a déclaré à l'AP qu'il conserve la majorité des paiements des fabricants d'appareils, mais que Falowski "pourrait recevoir une partie de ces paiements au moyen de sa rémunération annuelle".

Another of Falowski's patients was Lisa Snyder of Kempton, Pennsylvania, who was searching for relief from a painful nerve disorder. By the time she came to Falowski, she had cycled through three spinal-cord stimulators, which were removed for reasons ranging from infection to rejection.

"Not everybody could do it, but he was confident he could," she said.

After her fourth implant this March, "I complained about this battery right away. I knew it was positioned funny. It burned," Snyder said.

AP's analysis showed Abbott products were more likely than other major models to include reports of a hot or burning sensation near the site of the battery, with about 5,600 injury reports since 2008 referring to the words "heat" or "burn."

Abbott said that many of the "adverse events" reports in the FDA's data stemmed from a device that was voluntarily recalled in 2011. The company added that feeling a temperature increase at the implant site "is often a reality for rechargeable spinal-cord stimulation systems," which is why the company is now concentrating on devices that do not need to be recharged.

Snyder said she felt like Falowski's nurse and physician assistant downplayed the problems and that the reprogramming of her device was conducted by the Abbott sales representative, with no medical staff present. On at least one occasion, she was charged as if the medical staff was there, when she said they weren't, according to insurance bills reviewed by the AP.

Despite insisting nothing was wrong with the unit, Snyder said, Falowski called her one day out of the blue. "He said 'Under no circumstances are you to turn it on.' I asked him why and he wouldn't say," Snyder recalled.

Falowski then scheduled immediate surgery to remove the stimulator, she said.

Falowski called Snyder a difficult patient and said she was receiving "100 percent pain relief" when she had the stimulator removed, adding that she "remained very appreciative of her care." He added that programming is "performed under the direction of a physician."

"The physician is not present during the entire programming session, but provides oversight and direction….The only time programming sessions are billed is when the physician is actively seeing the patient during a visit which was the case with this patient," he said.

Snyder disputed the doctor's characterization of her and became angry after being told Falowski and his hospital received money from manufacturers.

"They need to be a little bit upfront," she said.

Falowski said doctors do important work for medical device companies, and he has been involved in device development, education, clinical trials and research.

"You're trying to help patients and you realize as a physician by yourself you're not going to generate $200 million to make the next best implant for a patient and it's going to take a company to do that," he said. "So I think the important part in that relationship is transparency and disclosures."

Experts interviewed by the AP said doctors are not legally required to tell their patients about financial relationships with medical device manufacturers, but that it would be the right thing to do.

"The patient should be fully informed before consenting to a procedure," said Genevieve P. Kanter, an assistant professor at the University of Pennsylvania who specializes in internal medicine, medical ethics and health policy.

All Snyder ever wanted was to feel better. Today, she often is immobilized by pain.

Before the latest stimulator, she could walk, stand and cook meals. Now, she finds it hard to get out of bed and rarely leaves her house. She says the device has ruined her life.

"My fear is I'll be like this forever," she said.