COLUMBIA, South Carolina (AP) – Unwanted for help after years of Agony, Jim Taft listened attentively as a doctor explained pain management was a medical device that could change his life.
He resolved the great damage in his right arm, Taft and his wife returned to the doctor saying, but a spinal spinal stimulus would be triggered; pain, and making it as good as it was new. "
Taft promoters failed shortly after it had been put into operation. After working for repairing, he said, the equipment had been disturbed for him many times that he could not sleep and dropped downstairs. Today, 45-year-old Taft has been a little paralyzed, a prisoner on his own bed, almost unable to go to the nursing home.
"I thought I had an amazing life," Taft said. "But look for me."
For years, medical device companies and doctors have removed spoonpop spirits as a copy for millions of patients who are ill-treated. suffering from a wide range of severe pain problems, making them one of the fastest results in the $ 400 billion medical device industry. Companies and doctors attack them as a safe defender to the deadly opioid crisis in the US and as a cure for older people. continued pain relief.
But the promoters – devices that use electric flows to block pain symptoms before reaching the brain – are more dangerous than the knowledge of many patients, searching for related research. They account for the largest number of injuries reports for medical devices in the Food and Drug Administration of the USA, with a focus on over 80,000 events since 2008.
Patients report that they are horrible or burned or have suffered stomach damage from spinal cord from weakness to paraplegia, FDA data shows. Among the 4,000 types of tools followed by the FDA, with the exception of chromatic metal and insulin pumps have recorded more injury reports.
There are more than 500 people with spunne spirals that have died on FDA information, but information is very tired, making it difficult to find out if the deaths were associated with the triggering attack or a # 39 ; including invasion.
Medical machine makers know that spinal mast promoters are safe – around 60,000 are submitted annually – and there are doctors who are infected. Specialization in these surgeries says they have helped to reduce pain for many of their patients.
Most of these tools have been approved by the FDA with very few clinical tests, however, and the company's data is & # 39; shows that there is a lower number of lesions caused by spoon promoters compared to hip implants, which are far more abundant.
The AP reported on backbone incentives as part of a bi-annual research on the global medical device industry that included the NBC, the International Conference of Journalists of Audit and over 50 other media partners around the world. Reporters were gathered and gathered; millions of medical records, and memories of other product safety alerts, as well as interviewing doctors, patients, researchers and timbers.
The media partners received more than 1.7 million injuries, and over 83,000 deaths, reported to the FDA over the last ten years.
The research also found that the FDA – considered by other countries to become a gold standard in the administration of medical devices – which is causing people at risk of doing so; pushing tools through a modified licensing process, and slowly responding when it is a while; Bringing companies to & # 39; materials.
Automatic tools are rarely taken away from the market, even when there are major problems. And the FDA does not show how many devices are being & # 39; submit in the SA each year – critical information that could be used to count reasonable and failing levels.
The FDA recognizes that its data has constraints, including errors, shortcomings and submissions; It can be hard to be able to confirm; machine may cause injury or death. But he refuses any suggestion regarding the survival of failure.
"There are more than 190,000 different market devices in the US. We have a clear or unacceptable agreement about twelve new or improved business-based devices," said Dr. Jeffrey Shuren, director of the FDA medical device at a Mayo business conference. "Fewer devices that are at any time in the media are smaller than the tools we can put to our market in One business day. That does not say that the system does not fail. It's amazing that the system works as it is. "
In response to reporter questions, the FDA said last week that he was doing a new task to "improve the safety of a stronger medical device for patients through better data." "Unfortunately, FDA can not always know the full level of benefits and the dangers of a machine before reaching its market," said his. group. In the last 50 years, the medical device's industry has been removing cure for some of the worst of today's curemans, including tools to cure or verify heart disease, cancer and diabetes
Pete Corby, who wound her back as a film supervisor, said a spoon stimulator helped her to deal with her, his pain and stop the opioids he would be responsible for.
"This is the best thing that saved my life, I saved my life literally," said Corby, saying that up to three-quarters of his original pain was reduced by the stimulator.
Medical machinery companies have "spent financial resources – both capital and human – in the development of latest compliance programs," said Janet Trunzo, technician leader and management issues, AdvaMed, a leading trading company. ; business.
At the same time, medical appliances have also spent billions to try to influence governors, hospitals and doctors.
In the United States, where drug makers and payrolls need to be distributed to doctors, the 10 largest medical machinery companies that have paid nearly $ 600 million for doctors or hospitals last year to consult consultancy costs, research costs travel and entertainment, according to AP and ICIJ analysis of data from the Centers for Medicare & Medicaid Services. This figure does not include payments from machine makers such as Johnson & Johnson and Allergan, who also have a & # 39; selling other items.
In addition, collective tables show that the four spoon-maker promoters have spent more than $ 22 million from 2017 to try to influence legislation that has been in place. benefit their entire business, which includes other devices.
Some companies have been punished to break up physicians, and illegally disrupt material for unprotected and unrivaled uses. Pay for surveys that identify the safety and effectiveness of their materials, according to their audit.
In the 2016 case, the agreement of Olympus Corp. of America, the largest distribution of myths in the Western Isles and associated medical equipment, $ 623.2 million "to solve crime costs and civil claims related to a scheme to break payable to doctors and hospitals, "according to the United States Department of Justice. Olympus said he "agreed to make a number of improvements to their compliance program."
Some doctors enthusiastically encourage spin tree promoters without being able to; to patients who received money from medical machinery makers. Some experts say that doctors are not legally required to publish such payments, but they have to do so. Sometimes the money goes to the doctors' hospitals, and not just directly.
In terms of Taft, he said that he just wanted to be better, but he has lost hope.
"This is my death sentence," said Taft, who stretched out under a wooden hand in his bed on which he carved the words "dead death."
"I'll die here," he said.
A generation ago, tens of thousands of women were injured by Dalkon Shield, an internal device that caused life-threatening illnesses. Users' candidates who carry out exams on demand and the pre-market approval of medical devices to prevent falls and falls related to faulty products.
So, in 1976, Transport moved to the changes for medical devices, law was reduced; means that the American tools would recommend their GPs good and not to. harm.
"Until today, American users can not be sure to have a medical device used by their doctors, their own hospital or their own safety and efficiency. Yes or not, "said President Gerald Ford when he signed his name; bill to law.
Expressed by law enforcement, the FDA created three classes of law; medical devices. The identification of highly dangerous substances such as spinal mast promoters is being maintained to the most rigorous clinical tests. But most of the tools are </ p>; going through a more intensive review process that will provide an easy access to the market for tools considered "largely equal" to agreed materials for use.
As planned by Congress, it should be & # 39; That process is to be taken out in part. Instead, it became the usual route to a market for thousands of tools, which included hip re-installations that were installed in tens of thousands of patients who would be re- Calls later due to some of the tools that would be used; metal making.
The AP found that the FDA had allowed some spoon promoters to access their & market without new clinical studies, largely agreed on the basis of results from earlier spinal stimuli surveys.
Vertebrate stimulants that extend electrical flows through wires are split into complexive devices, and Using a battery that is placed under the skin. The outside will control the device.
The four largest manufacturers of spinal mast promoters are Boston Scientific Corp., based in Marlborough, Massachusetts; Medtronic, with headquarters in Ireland and the USA; Nevro, in Redwood City, California; and Abbott based in Illinois, who went into the market after buying $ 23.6 billion of St Jude Medical Inc.
The request was not at St. Jude wants to go to market with his first spinal stimulus; including basic patient data and was based on clinical results from other surveys, and Boston Scientific's request for the promotion of spoonpower was largely based on older data, even though it was – Here is a small, original study of 26 patients found for just two weeks.
Once they have been agreed, pharmaceutical companies can use non-supplementary applications to change their products, even when the changes are substantive.
For example, only six spinal mast promotional devices have been approved since 1984, with 835 changes in addition to these devices that were issued during the year-round, the AP found. Medtronic received only 394 additional changes that have been triggered since 1984, which covers everything from changing its output; sterilization process to update the design.
"Diana Zuckerman, president of the National Center for Research, said the" type of story about the management of FDA devices, where they just add to its market " Health, who has investigated medical instruments for almost 30 years.
Manufacturers of medical devices have ensured enterprise-funded enterprises that show the effectiveness of the promotion of a spuncheon in the treatment of continuous pain. Experts say that there is a successful cure if pain is reduced by at least half, but not all patients are suffering; Feels that many pain has been reduced
The 2016 study has been able to look at different inspiration systems to & # 39; get "important evidence" that they were "safe, clinical and cost effective cure for a lot of situations of continuous pain."
But Zuckerman noted that the broader surveys came after the machines were widely used on humans.
"This patient is a pig in these patients," she said.
FDA said in a statement that it is licensing, and & # 39; cleaning or offering marketing support to 12 average business machine devices and its "based on reliable scientific evidence" conclusions are that the machines are safe and effective.
Dr. Walter J. Koroshetz, director of the brain problems and the stroke department at the National Institutes of Health, holds checks for medical devices such as spin-tree spin-triggers, which usually support business, with placebo effect "substantial".
"I do not know anyone who is happy with spinal mast technology as it is," said Koroshetz. "I think everyone thinks it's better."
Every time Jim Taft walked into his GP's office, he would look at the brochures that he had; spinal tax split – those with pictures of people who swim, & # 39; riding and fishing.
Inside the examination room, Taft said, telling his doctor that the device had been successful for his other patients and would improve his quality of life.
The employee's remuneration on life after breaking his right arm as he drew materials for an architectural engineering company, Taft had been on the move; Seeing the doctor for a period of five years before he decided to get a stimulator in 2014. He finally put it on, he said the doctor's plan for the removal of drugs.
"I was feeling back to the corner," said Taft, who's a staying in West Columbia, South Carolina.
Taft stated that he had a pain management technician who praised the technology, saying that promoters had improved the quality of his patient's lives. But four years later, Taft can not walk more than a few steps.
Taft is one of 40 patients interviewed by the AP who said they had difficulties with spinal mast promoters. Find the AP through online forums for people with medical devices. Twenty-eight of them said they had their spinal spirals; including reducing pain but left them worse when they were present.
Zuckerman, who has been working at the Scottish Department of Human Health and Human Services and a senior policy advisor at the First-First Lady Hillary Rodham Clinton, says there is no doctor to think they are ; cause harm to patients.
"But there is amazing incredible incentive to reduce, disable or forget the experiences of a patient and just look at how happy patients are," she said .
More than half of the patients interviewed with the AP reported that they felt that they were arrested to get inspirational because they were afraid they would have their doctors; cutting their remedies pain – the only thing helping them.
It is estimated to be & # 39; Responding to stimulators as "last resort" by insurance companies, as well as Medicare and Medicaid. That means your doctors need to follow a protocol before paying insurance for the device and submitting them.
Analysts need to show that foreign medicines can not help, and patients can also help; Get psychological evaluations to evaluate the likelihood of success. They usually get a test time to & # 39; Follow three days a week with a thin electrode placed under the skin. If patients say they are reassured from the conductor outside their & # 39; sending banners to the celebrities close to their spine, they persistently invade them to bring on continuous inspiration.
Taft said he had helped his three-day case; reduce pain, so a few days before going on, he started preparing for a new life. He ordered a lumber to restore his wife a patio and deck to his wife, Renee, as a thank you for her years of support.
In April 2014, Boston Scientific's Precision stimulator was installed in Taft by Jason Highsmith, Charleston, South Carolina, a neurosurgeon who received $ 181,000 from the company over the last five years and # 39; in consultation tax form and payments for travel and entertainment. Boston was a scientific sales representative in the working room – a common use, found the AP.
Highsmith would not mention the payments. Other doctors are protected, saying they are doing a very important job; help the companies – and at the end of patients – and they are entitled to be compensated for their time.
Since the bill was opened openly and put the device inside his body, it was only a problem, according to hundreds of sheets of medical records that were examined by the AP. The machine began to be converted randomly, and the battery burned its skin.
Taft and his wife complained again, but he told his doctors and the Boston Scientist told them that spinal mast promoters did not give up the problems they had; him.
That opposes Boston Scientific's own literature, which acknowledges that there are risks in back promoters and the means to insert them, such as the direction of the & # 39; movement, excessive multiplication, paralysis and disease.
This is also not seen in the AP's review of FDA injuries reports, found that burning and burning were reported for all key modules of spinal mast promoters. For Boston Science devices, the most commonly the disease of the most recent complaint over the last ten years, has been named in more than 4,000 reports injured.
In response to your questions, the company whose disease is "unfortunately is at risk in any permit" means that its company is working hard to avoid it. He said that the FDA data should not be defined as a definitive signal of challenge with our device. In fact, many instances of enumerated diseases include the ones caused by a & # 39; non-operational or post-care procedure. "
"In our internal quality appraisals, more than 95 per cent of the behavior reports were temporary or recycled in nature," added to its company.
Taft said he knew that the machines were so depressed, he would have reconsidered a man. Boston's representative of Boston tried to re-register the machine, he said, but nothing did work.
"Tell me that it's a feeling that the direction moves up and down my backbone," said Taft. "They said," He can not move. "" But in July 2014, X-rays revealed that the headteacher had actually moved two inches on one side.
Highsmith told the AP that butterflies broke from "strong activity," although Taft said that it would not be possible due to its situation. Taft said he was in a bad state after he had done his surgery that he could never make a patio and deck for his wife or do something strong.
In October, Highsmith said that he was working on a tape to install a new driver, check the batteries and restore it.
However, Taft's medical records show that he has continued on his / her; describes worry, suffering and pain. During the appointment of January 2015, a lawyer wrote that the "like to make its pain worse" was the device.
The stimulator was removed abruptly in August 2015. The following June, Taft received a second opinion from a clinic that specializes in drowsiness, and said that "an ancient pianist and low back due to "inserting and" expressing "of the promoter.
Highsmith said that other doctors had recorded bad arthritis in Taft and, although he did not investigate Taff in more than three years, he is "likely to have his current position as a result of progress of disease and other causes. "
He did not respond to questions about whether he was telling a tape of the dangers associated with promoters.
The doctor said that most of his spinal cord-spinal patients have a & # 39; a great respite of pain.
"Unfortunately, despite the main medical problems with such devices, some patients still suffer from anxious pain," he said.
Renee Taft, paralegal, came to Boston Science in 2017, but said he refused to help the company. her husband's promoter had been removed and her & her; Taft was blamed for his problems, and said he had been involved in "detailed corporate activity" after being treated.
In the letter from the legal department of the company, Boston Scientific also noted that federal law was Supporting makers from personal liability duties including medical devices agreed by the FDA.
In response to the questions from the AP, Boston Scientific was re-instantly sent to; blame on Taft's "activity level" but did not explain. The company also said that other factors could add to their problems such as "hyperalgesia, which is related to the use of long-term opioid that causes patients to become more aware of your motivation. "
Brenda Simpson-Davis of Milton, Florida, said that Boston Scientific was also considering her complaint after her husband had a disease that she had; threatening the life of its follow-up after treatment.
George Davis, 57, had three Medtronic crann-spinal implants, from between 2003 and 2007 after car patients had his backbone. They dropped some of his pain over time, but said that the re-repairing batteries that were intended to last for years have never been tired of; maritime causes.
In 2015, he had a pharmacy administrator to initiate the Boston Scientific Precision Spectra, which he called the best on his / her; market. Unlike Davis's old modules, it had a renewable battery.
Within weeks after his surgery, Davis said, he started feeling pain; burn down his back and feet and burn a sensation at the implant site. After turning black to the skin, the emergency surgery practiced the doctor to remove the device.
A few months later, Davis agreed unhappy when his doctor attempted himself to try another Boston Boston model but got that device worse.
Over the next year, he spent more than 100 days in and out of hospitals that faced a disease against her; threatening life. Today, Davis says it's hard to get out of bed.
Boston Scientific said he did not always find the promoters that were introduced in Taft and Davis and so he did not. They can "determine a decision" the reasons for their problems. "Several factors can contribute to the patient's continuing signs, by enhancing physical activity to the beginning of pain in other areas," said his company.
Simpson-Davis said she was speaking with advocates throughout the country, who warned her about the high rank set for a lawsuit. Eventually, she got a Texas lawyer who said he would think of the case if she gets two dozen other applicants.
"For me, not about the money it is, it's about the people. It's about knowing what they are getting in," she said.
Fad bhliadhnaichean, bha Valerie McJunkin air a bhith a 'sireadh cobhair bho eas-òrdugh neònach ainneamh a rinn a casan agus a casan a' faireachdainn gu robh iad nan teine. Mar sin, nuair a mhol dotair reic companaidh inneal meidigeach agus an dotair rianachd pian aice ann an Virginia an Iar dè a chuala i mar "inneal mìorbhaileach", bha i uile ann.
Thuirt iad gu robh seòrsa ùr de bhrosnachadh – aon a bha ag amas air cuibhreann de cheallan neònach mothachail anns a 'chùl ìseal – nas fheàrr na inneal cuibhle spinal. Dh 'fheumadh i a bhith a' dèanamh deuchainn fad seachdain.
Nuair a nochd McJunkin aig a 'chlinig pian seo san Fhaoilleach airson a' chùis-lagha, bha an neach-reic Abbott ann, còmhla ris an dotair agus an luchd-obrach aige. Mhìnich iad a h-uile mion-fhiosrachadh. Cha robh an uidheam seo airson a h-uile duine, ach b 'i an tagraiche ceart, thug i air ais iad ag ràdh.
Thairis air an ath sheachdain, thug iad air a 'mhòr-chuid dhi a bhith a' teacsadh a h-uile latha gus faighinn a-mach a bheil an neach-brosnachaidh a 'leigeil leotha a pian. Agus bhon a bha coltas gu robh an deuchainn a 'cuideachadh, chaidh i air adhart leis an implant.
Taobh a-staigh làithean, ge-tà, thòisich an inneal a 'cur dragh oirre air thuaiream – pian geur a bha a' faireachdainn mar bolt dealanach.
Nuair a dh 'ainmich McJunkin an dotair aice agus riochdaire Abbott, thuirt i gun robh iad a' moladh gun robh i air a 'chion seach nach eil "luchd-brosnachaidh a' dèanamh sin." Cha b 'ann gus an d' fhuair i litir dhearbhaichte bho Abbott sa Mhàrt gun do dh'ionnsaich i nach robh a h-uile rud na ceann: thuirt a 'chompanaidh gun robh an inneal aice air a ghairm air ais mar thoradh air glitch a dh' adhbhraicheadh euslaintich "mì-chofhurtachd".
Bho 2005, tha 50 cuimhne air a bhith a 'gabhail a-steach luchd-brosnachaidh droma, averagh mu cheithir sa bhliadhna anns na còig bliadhna mu dheireadh. Bha mu leth de na cuimhneachaidhean a 'toirt a-steach luchd-brosnachaidh a rinn Medtronic, an neach-dèanamh innealan as motha air an t-saoghal, ged nach robh rabhadh sam bith ann a thaobh cunnart bho dhroch leòn no bàs.
Tràth san t-Sultain, thug McJunkin cuireadh do neach-aithris AP a dhol còmhla rithe nuair a choinnich i ri a dotair agus riochdaire reic a 'chompanaidh gus iarraidh air an inneal a thoirt air falbh.
Thuirt fear-reic Abbott agus an dotair aice gun robh i a 'faighinn neach-brosnachaidh eile, ag ràdh gu robh i air a dhol a-mach à roghainn, gu h-àraidh bhon nach b' urrainn dha a dotair òrdughan a sgrìobhadh airson opioids air sgàth casg an riaghaltais. Mura faigh i spreaghadair eile, thuirt e, gu robh i a 'dol an aghaidh beatha pian. Cha do mholadh e roghainnean eile, mar shòlaidhean steroid no leigheas corporra leantainneach.
"Chan eil mi a 'feuchainn ri do inntinn a thoirt seachad," thuirt an dotair. "Ach dhòmhsa, am bu mhath leam mo bheatha mar seo a dhèanamh? … Ma gheibh mi am bataraidh ùr sin agus tha e gu tur a 'cuideachadh, tha sin a' toirt atharrachadh air mo bheatha 180 céim, ceart? Ach mura dèan mi fios mar-thà dè a tha dol tachairt rium: bidh mi a 'fulang airson a' chòrr de mo bheatha. "
Air an t-slighe dhachaigh gu Martinsburg, Virginia an Iar, ghlac McJunkin roth-stiùiridh a 'chàir aice, agus bha a tatù a' leughadh "persevere" ri fhaicinn air a 'bhogsa aice.
"Tha thu a 'earbsa air do dhotair. Tha thu a' smaoineachadh gu bheil e a 'dol a dhèanamh an rud ceart," thuirt i. Stad i, a 'sabaid air deòir. "Bha mi dìreach airson fuireach gun phian. Ach a-nis tha an dòchas sin air falbh."
Aig deireadh an Dàmhair, thug a dotair an inneal air falbh.
Bha an eòlas aig cha mhòr a h-uile 40 euslainteach a chaidh agallamh leis an AP a 'sealltainn McJunkin's: Chaidh am pian aca a lùghdachadh rè na deuchainn ach thill iad nuair a chaidh na pìolairean aca a chur a-steach.
Tha eòlaichean ag ràdh gur dòcha gur e àite placebo a chaidh a chruthachadh nuair a thèid sùileachadh a thogail anns a 'chùis-lagha nach fhaigh ach an neach-brosnachaidh faochadh bho pian, le euslaintich nach eil ag iarraidh a bhith a' briseadh-dùil buill teaghlaich, a tha gu tric air a bhith a 'frithealadh mar an luchd-cùraim aca.
"Ma tha fios aig euslaintich gur e seo an roghainn mu dheireadh, dòchas mu dheireadh, gu dearbh bidh iad a 'freagairt gu math," thuirt an Dotair Michael Gofeld, eòlaiche anesthesiologist agus stiùireadh pian a th' air a bhith a 'sgrùdadh agus a' toirt a-steach luchd-brosnachaidh crann-spàin anns na SA agus Canada.
Mun àm a thig an deuchainn gu crìch, tha an t-euslainteach "ag itealaich àrd, tha na h-ìrean endorphin àrd," thuirt Gofeld.
Tha riochdairean dèanaimh gu mòr an sàs anns a 'phròiseas gu lèir. Còmhla ri gu tric a bhith anns an t-seòmar-obrachaidh nuair a bhios an lèigh-lann air eagal 's gu bheil ceistean aig an dotair, bidh iad a' coinneachadh ri euslaintich gus na h-innealan a chlàradh sna seachdainean às deidh an lannsaireachd
Thuirt a 'mhòr-chuid de na h-euslaintich agallamh leis an AP gun robh na h-atharrachaidhean air na h-innealan aca gan coileanadh le riochdairean reic, gu tric gun dotair no banaltram an làthair. Tha sin a 'toirt a-steach aon euslaintich a chaidh a chlàradh airson prògramadh mar gum biodh an dotair anns an t-seòmar, ged nach robh e.
"Cha bu chòir daoine a tha a 'reic an uidheam a bhith an urra ri cumail suas," thuirt Craig. "Tha e gu tur mì-chothromach."
Ann an cùis Texas ann an 2015, seann iarrtais riochdaire reic Medtronic a 'cumail a-mach gun deach a losgadh às deidh a' ghearan gun robh an companaidh a 'trèanadh luchd-obrach gus neurostimulators a chlàradh gun lighichean an làthair. Dh'iarr i cuideachd gun do stiùir stiùiriche Medtronic miotagan ceadaichte a-mach bhuaipe nuair a dhiùlt i an t-euslainteach a ghlanadh rè dòigh-obrach, ga phutadh agus a ghlanadh agus a sgeadachadh. Dhiùlt Medtronic na casaidean, agus chaidh a 'chùis a rèiteachadh air teirmean nach deach fhoillseachadh.
Ann an cùis Roinn a 'Cheartais a' toirt a-steach Medtronic, fear-reic a thuirt gun do chosg e uiread de $ 600,000 sa bhliadhna a 'reic luchd-brosnachaidh crann-spàin a thuirt gun robh luchd-reic a' brosnachadh lighichean gus modhan-obrach neo-riatanach a choileanadh a chuir suas na cosgaisean airson prògraman slàinte Medicare agus slàinte eile.
"Ged a tha beagan shuidheachaidhean air a bhith ann far nach do choinnich daoine no cleamhnasan ri poileasaidhean Medtronic, rinn sinn an gnìomh gus an suidheachadh anns gach cùis a leigheas aon uair 's gun deach a lorg agus gus mì-ghiùlan sam bith a cheartachadh," thuirt a' company.
Thuirt Craig gum biodh e a 'creidsinn gu bheil luchd-brosnachaidh a' dèanamh obair, ach mar as trice bidh mòran de na duilgheadasan ag èirigh nuair a tha dotairean a 'taghadh thagraichean iomchaidh. Agus tha e den bheachd gu bheil na brosnachaidhean air an cleachdadh gu tric ann an SA.
Tha Nevro, fear de na ceithir luchd-dèanamh mòr, air luaidh a thoirt air tuairmsean gu bheil uiread de 4,400 goireasan anns na SA far a bheil innealan brosnachaidh spinal air a thoirt a-steach le diofar lighichean, nam measg innealan-leigheis, eòlaichean-inntinn agus eòlaichean pian.
Tha e na ghnìomhachas math. Tha luchd-sgrùdaidh ag ràdh gu bheil luchd-brosnachaidh agus an obair-lann gus cosgaisean a thoirt dhaibh eadar $ 32,000 agus $ 50,000, leis an inneal fhèin a 'dèanamh $ 20,000 gu $ 25,000 den t-suim sin. Ma thèid an lannsaireachd a dhèanamh ann an ospadal, mar as trice bidh an t-euslainteach a 'fuireach thar oidhche, agus bidh an t-ospadal a' cosg cìs ghoireasan airson an inneal fhaighinn. Mar as trice bidh cosgaisean air an còmhdach le àrachas.
Lorg an AP gum faod dotairean barrachd airgid a dhèanamh ma bhios iad a 'dèanamh an lannsaireachd aig ionadan-lannsa luchd-cùraim taobh a-muigh an dotair, bho tha an dotair a' ceannach an uidheim, ga chomharrachadh agus a 'cur ris a' chìs ghoireasan.
Ann an Canada, far a bheil Gofeld a-nis ag obair, thuirt e nach eil na freiceadan-lann gan dèanamh ach leis an fheadhainn a tha a 'speisealachadh anns na modhan-obrach. Thuirt e gum bu chòir luchd-brosnachaidh crann spinal a bhith air an cleachdadh nuair a thòisicheas pian agus gun a bhith a 'fàgail ionadan-lann air ais.
"Ron sin," thuirt e, "tha e ro fhadalach."
Ged a tha luchd-dèanaidh agus oifigearan àrda FDA a 'toirt ionnsaigh air mar a bhith a' toirt ionnsaigh air a 'bhlàr an aghaidh opioids, tha innealan-leigheis leithid Steven Falowski nan eun-eòlaichean air thoiseach.
"Is e pian èiginn aon de na h-eallach as motha a th 'againn san t-slàinte ann an SA. Tha e nas motha na tinneas cridhe, aillse agus tinneas an t-siùcair còmhla," thuirt Falowski ann an agallamh.
Thug e AP air adhart gu Corby, mar aon de na h-euslaintich eachdraidheil aige a chuidich le brosnachadh crom-spàin.
Corby got the device more than two years ago and says that, after some initial adjustments, he hasn't had any further problems. He says he wouldn't trade the stimulator for opioids.
"I was actually buying them on the street … a little like a druggie because I couldn't get them anymore" from his pain doctor, Corby said.
Falowski said opioids are good for acute pain, but were never meant to treat long-term chronic pain. For him, that's where spinal-cord stimulators come in.
If they're used early enough for pain, they can prevent people from going on opium-based pain killers, said Falowski, who speaks at neuromodulation conferences and teaches other doctors how to implant stimulators.
Since 2013, device manufacturers have paid Falowski — or St. Luke's University Health Network in Fountain Hill, Pennsylvania, where he works — nearly $863,000, including $611,000 from St. Jude or its new parent company, Abbott, according to the Centers for Medicare and Medicaid Services database. The payments range from consulting fees to travel and entertainment expenses.
Falowski said he has conducted research and done other work for manufacturers, adding, "The contracts with industry are with my hospital and not with me."
St. Luke's told the AP that it keeps the majority of the payments from device makers, but that Falowski "may receive a portion of these payments through his annual compensation."
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.
Washington D.C.-based Associated Press reporters Meghan Hoyer and Matthew Perrone contributed to this report, as did Denver-based video journalist P. Solomon Banda.