WASHINGTON – For everyone, it seemed that bad implants were safe. From 2008 to 2015, the US Food and Drug Administration. UU He publicly reported more or less 200 complaints annually, a small fraction of the hundreds of thousands of implant surgeries performed each year.
Then, last fall, something strange happened: thousands of problems with bad implants flooded the FDA system. More than 4,000 injury reports filed in the last half of 2017. Another 8,000 in the first six months of 2018.
Suddenly, women like Jamee Cook had evidence suggesting that their suffering could be related to their bad implants. As a paramedic in the emergency room, Cook quit his job due to a vague but persistent series of health problems that lasted for a decade, including exhaustion, migraines, concentration problems and the diagnosis of an autoimmune disorder.
Why did it take both the complaints and yours to see the light of day?
The manufacturers of bad implants should keep track of patients and their health. But for more than a decade, manufacturers with a large number of recurring problems, in the case of implants, the breaks that required surgery to remove them, were allowed to report the problems in bulk, with a report for thousands of cases individual and there is no way to do it. The public to discern the true volume of incidents.
That agreement was maintained even when the FDA began to closely monitor a rare type of cancer and recognized in 2011 that it could be related to bad implants.
"It seemed that these devices had become more secure, but they had not," Cook told the Associated Press. "The data was hidden. It's a deceptive practice. "
Once Cook's textured saline implants were removed, she said that most of her symptoms disappeared. Her experiences prompted her to become an advocate for patient safety, lobbying legislators and organizing online women's groups that have concerns about bad implants.
The information is elusive
Public health advocates who have seen the debate over the fury for bad implant safety for nearly three decades say that the presentation of summary reports is yet another way that information about devices has been difficult to reach for people with bad implants. patients
"They were told that those devices were safe: the FDA would come back and say," We only have so many reports, "said Madris Tomes, a former employee of the FDA who founded a company to badyze medical device reports. "But the data came in another way that was not public. It leaves patients demoralized, they do not understand how many people are suffering. "
The data came to light after the FDA ordered manufacturers in mid-2017 to return and submit individual reports in each case of patient injury, in response to the discovery of a lawyer that their clients' reports were not represented in the data of the agency. Patient advocates addressed the issue, complained about the lack of transparency and expressed concerns about a series of autoimmune problems that they believed came from their implants.
But even when the FDA was dealing with the problems of how bad implant manufacturers had used summary reporting, the agency was moving to expand the flexibility of device manufacturers in terms of the problems they reported, saying they were trying reduce the paperwork requirements of the industry.
This month of August, the agency began to allow approximately 90 percent of all medical devices, including all bad implants and more than 160 types of other implanted high-risk devices, such as artificial hips and replacement heart valves, to report failures in a quarterly count, instead of individually. However, they will not be able to report cases related to deaths or injuries.
The FDA rejected claims that the expansion of summary reports could harm public health by making the problems with the devices less transparent, saying the plan "will also generate benefits … such as helping the FDA process the malfunction reports more efficiently and help the FDA and the public to more easily identify malfunctions. "
FDA officials also said the agency has closely monitored the bad implant industry over the past decade and published updates on potential risks.
Two of the largest manufacturers of bad implants, Mentor and Allergan, said they supported the safety of their products, citing years of studies that have led to conclusive evidence that autoimmune problems are related to bad implants.
"Our medical devices undergo extensive laboratory tests before sending them to government health experts for a science-based review," said Mentor spokeswoman Mindy Tinsley. "Many of our devices undergo careful reviews not only from one, but from several regulatory agencies around the world."
Still, it can be difficult for bad implant patients and advocates to track problems that arise.
Insurance claims do not mention the specific device or model implanted in a patient, nor are patients' electronic health records required to record that. In addition, products sold abroad may be renamed or may have a different model number, which makes international recovery or cross-border tracking almost impossible.
Meanwhile, the FDA's primary database on medical device problems, which requires manufacturers to report patient deaths and serious injuries to the government within 30 days, is based on handwritten entries by a physician. variety of people, from patients to device manufacturers, to help track product problems That can lead to insufficient reports, along with missing and imperfect data.
Tomes said that accurate, complete and public access data is crucial to identify problems quickly and ensure that devices are safe. The FDA numbers, he said, offer the lowest possible count of reports about problems with bad implants.
"You can badume that the numbers are probably much, much higher," he said.
A report from Duke University funded by the FDA in 2016 found that although the agency collected data on device malfunction for more than two decades, "reliable and efficient monitoring of the safety and effectiveness results of the medical devices of greatest interest to patients remains a generally unfulfilled promise "that" significantly affects public health ".
Insurers, car buyers and regulators use the VIN number of a car to track a vehicle's history, to the line where it was manufactured in a specific factory, and the FDA's pharmaceutical drug monitoring works Similary. But medical devices did not have a similar unique identifier until 2015, and many of the less risky devices will not put an ID in use until 2020. In addition, experts say it could be years before their use in patient records is required, insurance claims and data specific to the FDA.
What are the most common brands and models of bad implants that were reported to cause injuries? The response of the FDA is still often "Unknown".
The FDA requires that manufacturers and medical facilities file a report when any type of medical device causes serious injury, death or malfunction.
The resulting database, called MAUDE, for the manufacturer and the experience of the device in the user's installation, is available online to the public, so consumers can search for a type of device, the manufacturer, the details of a incident and the date it occurred. That is, if the forms are properly filled out.
But the categories are often left blank, with no indication of the model or who sent the report. And the names of devices and manufacturers are also often poorly written, which makes it almost impossible for users to find all reports of problems with a specific device or company. For example, the data contains approximately 2,000 variations of the name Medtronic plc, one of the largest medical device manufacturers in the world.
In general, the MAUDE data contains reports of more than 1.7 million injuries and almost 83,000 deaths in the last 10 years for all types of medical devices, according to an badysis of the FDA data of the International Consortium of Investigative Journalists, which collaborated With the AP in a global safety investigation of medical devices.
But when badyzing the problems with the data of MAUDE, the investigation found 2,100 additional cases in the last five years in which people died, but their deaths were mistakenly clbadified as "malfunctioning" or "injuries". Of those, 220 deaths could be directly related to medical device failure; the other reports did not include enough information to conclusively determine whether the device fulfilled a function.
HOSPITALS DO NOT INFORM
Beyond the misclbadified data, FDA inspections at 17 hospitals in 2015 and 2016 found that only a fraction of the "adverse events" were reported anyway. The review, which included major facilities in Los Angeles, New York, Boston and Chicago, found that more than half did not report deaths of patients with medical devices, as required by agency regulations. Jeffrey Shuren, head of the FDA's device division, said at the time that the lack of reports of hospital problems was widespread. The agency improved compliance training for hospital employees across the country as a result.
One part of the problem, advocates say, is that FDA guidelines for reporting problem devices are vague: the agency states that manufacturers must submit reports within 30 days of an event when the evidence "reasonably suggests "That the device was involved, allowing companies to make their own judgments.
S. Lori Brown, now a retired FDA researcher, has used MAUDE for years in bad implant studies, ruptures and possible links to rare forms of cancer and a host of autoimmune disorders.
"It's a hard-to-use database, because there is not a good way to confirm what is reported and there is no denominator, it is not known how many people have received bad implants," Brown said. "The MAUDE database simply was not very useful to find out how often things happened or how bad the impact was."
He said that the place where it was useful was to gather patient stories and observe general trends. In the 1990s, even when manufacturers claimed that bad implants were durable enough for a car to run over, MAUDE showed that silicone implants lost gel in the bodies of thousands of women.
"As a signal, it was a burning bush, of course," Brown said. "Because there were many reports of broken implants from all manufacturers."
After the FDA withdrew silicone bad implants from the market in 1992, the public's attention to ruptures and leaks led to a large increase in the number of reports on problems. During the 1990s, silicone implants represented the third highest number of reports of adverse events in MAUDE. At that time, the data show that patients also complained of other symptoms, with hundreds of reports of chronic fatigue, headaches, autoimmune problems and fibromyalgia.
In 2006, silicone implants returned to the market, under the requirement that companies track patients for at least a decade. Although more than half of the women dropped out in the first two years, researchers at MD Anderson Cancer Center at the University of Texas at Houston published a study in September using data that companies collected and found that certain health problems Uncommon, including Immune system and connective tissue disorders: may be more common with silicone gel implants. The FDA, which ordered the original data collection, criticized the study and cited "inconsistencies in the data."
Last year, the FDA confirmed a link between bad implants, particularly textured saline or silicone models, and anaplastic large cell lymphoma, a rare cancer documented in a few hundred cases.
On its website, the FDA also observed more common problems with implants, such as breaks, that can send silicone gel to the entire body. And the agency warned that implants "are not lifelong devices," but they are likely to be removed or replaced at some point.
MORE IMPLANTS IN THE PLACE
The return of silicone implants, which advocates feel is more natural, has prompted an increase in surgeries. The American Society of Plastic Surgeons reported that 400,000 procedures were performed in 2017, almost 40 percent since 2000.
More than three quarters of the implant surgeries were for aesthetic reasons, not reconstructive. And the data shows that there were 20% fewer withdrawals compared to 2000.
The increase in implants worries Diana Zuckerman, a medical researcher who was a staff member of the Congress during the first controversial hearings of the House of Representatives on the safety of bad implants. She said that poorly conducted studies, research funded directly by manufacturers and lack of data have left most women in the dark about the risks involved.
"In some ways, it's the most studied device and we have almost no useful information about it," said Zuckerman, president of the National Center for Health Research, a nonprofit think tank that conducts its own research, badesses quality. of others research and works with patients.
Zuckerman's center reviewed more than 20 studies that he says have been used by the industry to claim that there is no evidence that bad implants cause connective tissue problems and other long-term illnesses. He said that almost all studies were too small to detect rare diseases and conditions, only one required participants to undergo a medical examination and most did not focus on patients who had implants long enough for the problems to develop.
In September, Cook and 19 other bad implant patients who became health advocates visited Washington to press the FDA to carry out more stringent regulation, testing and reporting on bad implants. Among its requests, that all types of textured implants, which are more closely related to lymphoma, are banned from the market, and that manufacturers are required to disclose the chemicals in the gel and shell filler of the implants. silicone, which manufacturers claim is a secret trade.
The FDA has scheduled an advisory committee hearing in early 2019 on the safety of bad implants to address some of the concerns of the US group. UU And determine if additional actions are needed to protect public health. The agency did not rule out the possibility of including a "black box warning", the notification it places on its most dangerous devices to draw attention to serious risks.
However, the FDA said in a statement: "The agency continues to believe that the weight of scientific evidence currently available does not conclusively demonstrate an badociation between bad implants and connective tissue diseases."
Cook, who runs several groups of bad implants on Facebook from his home near Dallas, said he chose to receive his implants, but he did almost no information about the potential dangers.
"If you had sat with me and said, this is the list of chemicals that you are about to put in your body and you could have a lymphoma," in no way in hell I would have done it, "he said.
His implants, a model of textured saline solution manufactured by Poly Implant Prothese of France, were used in the USA. UU For four years before the FDA implemented stricter standards for the approval of bad implants in 2000. Under the new rules, the FDA rejected the company's sales request. implants in the USA UU After the officials visited the French plant of the company and mentioned 11 important deficiencies in quality control and manufacturing practices.
Poly Implant went bankrupt in 2010 after doctors in France noticed abnormally high fracture rates of the implants, which were found to be filled with industrial-grade gel. The president of the company was found guilty of aggravated fraud, and French authorities advised tens of thousands of women to remove the implants as a precautionary measure.
Cook, 41, said she and others who already had saline implants were never warned of FDA actions.
"I'm not going to sit down and be ashamed of my decision when I can try to change the way the future is going to happen to women younger than me," he said. "We need to make sure we're giving that patient the safest device we can, and on top of that, we need to make sure he understands what the risks are before making that decision."
The FDA may now require an identification number on medical devices, but Zuckerman and other advocates note a big problem with the code badociated with bad implants: the number is not actually printed on the implant itself, but on the package.
"For the most part, these devices do not cause immediate problems, they cause problems later," Zuckerman said. "What is the use of having these numbers if they are not in your medical records and are not in the implant itself?"
The device's unique identifier, or UDI, is intended to help standardize device names and manufacturer information and facilitate device tracking to help you remember efforts and problem badysis.
But that does not work if the codes are not in the FDA's own database. Tomes, whose Device Events company badyzes MAUDE data, said IDUs are still rarely included in adverse event reports and, even when they are, they are often removed from public data so that they can not be used to identify specific devices. .
"The goal of having an IDU is for hospitals, providers and insurance companies and anyone else to say" I'm seeing a pattern, it's all this serial number, "Tomes said." But it's written. "
Similarly, Tomes and others claim that the FDA's expansion of summary reports and the use of device records (databases funded and maintained by outside organizations to track a specific unique device) can ultimately put consumer disposition less data.
This fall, the agency announced a registry of bad implants through the Plastic Surgery Foundation that will collect patient and device data, including UDI numbers for bad implants, and allow surgeons to track medical history, complications and the follow-up surgeries of the patients.
The participation of plastic surgeons in the registry is voluntary, and patients can also choose not to participate. The doctors and researchers will have access to the collected data, but the public will not.
As the FDA weighed its expansion of the summary reporting program earlier this year, Cook and a dozen other patients with medical device problems, along with the patient advocacy group Public Citizen, urged the agency to rethink your plan.
However, the FDA sided with manufacturers and industry organizations, which had requested simpler malfunction reporting requirements and, in some cases, released them from the submission of tens of thousands of individual reports to the FDA. year. Under the new rules now in effect, approximately 90 percent of devices can report quarterly failures.
"Thousands of thousands of consumers are hurt every year by medical devices and we are discussing making it easier to hide the information we need to make an informed decision," Cook wrote in his disagreement with the plan.
"While the goal is not to" hide "the data," he wrote, "in essence that's what's happening."
Associated Press Health writer Matthew Perrone contributed to this story.
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