breast implants reveal problems in tracking device safety

by:Yucai     2019-12-28
WASHINGTON (AP)—
Breast implants is safe worldwide.
From 2008 to 2015, the United StatesS.
The Food and Drug Administration publicly reports about 200 complaints every year.
Only a small percentage of the thousands of implant surgeries performed each year.
Strange things happened last fall: The FDA system was filled with thousands of breast implants problems.
More than 4,000 injuries were reported in the second half of 2017.
In the first six months of 2018, an increase of 8,000 per cent.
All of a sudden, women like Jamee Cook have evidence that their pain may be related to breast implants.
As an emergency room caregiver, Cook has quit his job because of a series of vague but persistent health problems that have been going on for more than a decade, including fatigue, migraine, inattention and autoimmune diseases
Why does it take so long for complaints like her to see the light?
Breast implants are required to follow up on patients and their health.
But for more than a decade, there have been a lot of problems with manufacturers that have been recurring.
In the case of an implant, a rupture requiring surgical resection is required
A large number of issues were allowed to be reported, and one report represented thousands of individual cases and the public was unable to discern the number of real events.
Even if the FDA began to closely monitor a rare cancer and admitted in 2011 that it may be related to breast implants, the agreement remains in force.
\"It looks like these devices have become safer, but they don\'t,\" Cook told The Associated Press . \".
\"Data is hidden.
This is a deceptive practice.
She said most of her symptoms disappeared once Cook\'s textured saline implant was removed.
Her experience has prompted her to become a patient safety advocate, lobby lawmakers, and organize women\'s groups online that have concerns about breast implants.
Public health advocates who have been watching the debate about breast implant safety anger for nearly 30 years say the summary report is another way for patients to have difficulty obtaining information about these devices.
\"They were told that the equipment was safe --
The FDA will go back and say, \'We only have so many reports, \'\"said former FDA staff member Madris Tomes, who founded a company to analyze medical device reports.
\"But the data appears in another way that is not public.
This makes the patient low.
They don\'t understand how many people are still suffering.
\"After the FDA indicated the manufacturer in the medium term, the data was exposed
2017 in the event that each patient is injured, go back and submit a personal report in response to the lawyer\'s finding that his client\'s report is not represented in the agency\'s data.
Patient advocates discussed the issue, complained about the lack of transparency, and expressed concern about a range of self-immunization issues that they thought originated from implantation.
But even if the FDA is dealing with the issue of how breast implant manufacturers use summary reports, the agency is expanding the flexibility of device manufacturers to report problems, the company said, trying to lower the paperwork requirements of the industry.
In August, the agency began to allow about 90% of medical equipment.
Including all breast implants and more than 160 other breast implants
Risk implants such as artificial hip joint and replacement of heart valves-
Reporting failures by quarter rather than separately.
However, they will not be able to report cases involving death or injury in this way.
The FDA has rejected claims that expanding the summary report may harm public health by reducing transparency in equipment issues, saying the plan \"will also bring benefits \".
For example, helping the FDA deal with failure reports more effectively and helping the FDA and the public identify failure trends more easily.
FDA officials also said the agency has been keeping a close eye on the breast augmentation industry for the past decade and has released updated information on potential risks.
Mentor and Allergan, the two largest breast implants manufacturers, said they supported the safety of the product, citing years of research that led to evidence of uncertainty about the issue of self-immunity associated with breast implants.
\"Our medical devices have been tested in a wide range of laboratories before being submitted to government health experts for scientific research --
Mentor spokesman Mindy Tinsley said.
\"Many of our devices have not only been carefully reviewed by one agency, but also by multiple regulators around the world.
\"Nevertheless, it is difficult for patients and advocates of breast implants to follow up on issues that do arise.
The insurance claim does not mention specific equipment or models implanted into the patient\'s body, and the patient\'s electronic health record does not need to be recorded.
In addition, products sold overseas can be renamed or different models can be used, which makes it almost impossible for international recalls or cross-border tracking.
At the same time, the US Food and Drug Administration\'s main database on medical equipment problems requires manufacturers to die and seriously injured patients within 30 days, relying on manual
Typing entries from a variety of people-
From patients to equipment manufacturers
Help track problem products.
This can lead to insufficient reporting, as well as data loss and defects.
Accurate, complete and open data is critical to quickly detect problems and ensure device safety, Tomes said.
She said the FDA figures provide the lowest number of reports on breast implants issues.
\"You can assume that the numbers may be much higher,\" she said . \".
A report from Duke University, funded by the US Food and Drug Administration in 2016, found that although the agency collected data on equipment failures for more than 20 years, \"reliable and effective tracking of the safety and effectiveness of medical devices that patients are most interested in remains a generally unfulfilled commitment\", \"seriously affecting public health.
\"Insurance companies, car buyers and regulators all use the VIN number of the car to track the history of the car until the production line it makes at a particular factory, and the FDA\'s own drug regulation is equally effective.
But it was not until 2015 that medical devices had similar unique identifiers, many of which were the least
The ID will not be used by the risk device until 2020.
In addition to this, experts say it may take several years to use these drugs in patient records, insurance claims, and FDA\'s own data.
It is reported that what is the most common brand and model of breast augmentation surgery?
The FDA\'s answer is still often \"unknown \".
\"_ FDA requires manufacturers and medical institutions to submit reports when any type of medical device causes serious injury, death or failure.
Generated database-
Manufacturer and user facilities equipment Experience Center-MAUDE
The public can find it online so that consumers can search for device type, manufacturer, details of the event and the date of the event.
That is, if the form is filled in correctly.
But the category is usually blank and there is no one showing the model or submitting the report.
Device names and manufacturers are also frequently misspelled, making it almost impossible for users to find all problem reports for a particular device or company.
For example, the data contains about 2,000 variants of Medtronic plc name, one of the world\'s largest medical device manufacturers.
Overall, the MAUDE data contains more than 1 report.
According to the analysis of FDA data by the International Federation of investigative journalists, 7 million people have been injured in all types of medical devices and nearly 83,000 have died in the past 10 years, work with The Associated Press on the global medical device safety survey.
However, in studying the problems with the MAUDE data, the survey found that another 2,100 deaths have occurred in the last five years, but their deaths have been incorrectly classified as \"faulty\" or
Among them, 220 deaths may be directly related to medical device failures;
Other reports did not include sufficient information to determine whether the equipment was working.
In addition to the misclassified data, FDA inspections at 17 hospitals in 2015 and 2016 found that, in any case, only a small number of \"adverse events\" were reported. The review —
Major amenities including Los Angeles, New York, Boston and Chicago-
It was found that more than half of the people did not report the death of patients with medical devices according to the rules of the agency.
Jeffrey Schulen, the head of the FDA\'s equipment department, said at the time that the hospital\'s underreporting problem was widespread.
As a result, the agency has strengthened compliance training for hospital staff across the country.
Advocates say part of the problem is that the guidelines for the FDA to report the problem device are vague --
The agency said that within 30 days of the event, when the evidence \"reasonably implied\" that a device was involved, the manufacturer needed to report, allowing the company to make its own judgment. S.
Lori Brown, now a retired senior FDA researcher, has been using Morder for years in her studies of breast augmentation, rupture, and possible connections to rare cancers and a range of autoimmune diseases.
\"This is a database that is hard to use because there is no good way to confirm the contents of the report and there is no denominator --
\"You don\'t know how many people have had breast implants,\" Brown said . \".
\"The MAUDE database does not help much to find out how often or how seriously things happen.
She said it was helpful in collecting patient stories and understanding the big trends.
In the 1990 s, although manufacturers claimed breast implants were durable enough to be run over by cars without breaking, MAUDE showed silicone implants leaking the gel into thousands of women.
\"As a signal, it\'s a burning bush,\" Brown said . \".
\"Because every manufacturer has a lot of reports about the rupture of the implant.
\"After the FDA removed silicone breast implants from the market in 1992, public concern about the rupture and leakage led to a surge in the number of reports on the issue.
During 1990 s, the silicone implant represents the third
The largest number of adverse events reported by MAUDE.
Data at the time showed that patients also complained about other symptoms, with hundreds of reports of chronic fatigue, headaches, self-immune problems and fibromyalgia.
In 2006, silicone implants returned to the market at the request of the company to track patients for at least ten years.
While more than half of women withdrew from the study in the first two years, researchers at the Anderson Cancer Center at the University of Texas in Houston released a study in September using data collected by these companies, some rare health problems have been discovered --
Including the immune system and the disease
Silicone gel implants may be more common.
The FDA, which authorized the collection of raw data, later criticized the study, saying it was \"inconsistent data \".
\"Last year, the FDA did confirm the link between breast augmentation surgery, especially with textured saline or silicone models, and anaplastic large cell lymphoma --
Only a few hundred cases have recorded a rare cancer.
On its website, the FDA also pointed out more common problems with implants, such as rupture, which can send silicone gel to the whole body.
The agency warned that the implant \"is not a lifelong device\" but may need to be removed or replaced at some point.
With the return of silicone implants, advocates say it feels more natural, driving a surge in surgery.
According to the American Society of Plastic Surgery, 400,000 operations were performed in 2017, an increase of nearly 40% since 2000. More than three.
Part of the reason for the implant surgery is cosmetic surgery, not reconstruction.
According to the data, the removal volume decreased by about 20% compared with 2000.
The increase in implants has raised concerns among medical researchers Diana Zuckerberg, a congressional staff member at the earliest controversial House hearing on breast augmentation safety.
Poor performance studies, research directly funded by manufacturers, and lack of data left most women clueless about the risks involved, she said.
\"Somehow, this is the most researched device, and we have little useful information about it,\" said zukman, president of the National Center for Health Research, A non-profit think tank that works on its own research, evaluates the quality of other people\'s research and works with patients.
The center of Zuckerman reviewed more than 20 studies, saying the industry has used them to claim that there is no evidence that breast implants can lead to connectivity tissue problems and other long-termterm illnesses.
Almost all studies were too small to detect rare diseases and conditions, she said, with only one requiring participants to have a physical examination and most people not paying attention to patients who had been implanted long enough to solve the problem.
Cook and 19 other breast implants in Septemberturned-health-
Advocates visited Washington to lobby the FDA for stricter regulation, testing and reporting of breast implants.
In their request
All textured implants that are more closely related to lymphoma are prohibited from entering the market and require manufacturers to disclose chemicals in the silicone implant housing and gel filling, which the manufacturer claims is a trade secret.
The FDA has planned to hold an advisory committee hearing on the safety of breast implants in early 2019 to address some issues in the United StatesS.
Determine if additional action is needed to protect public health.
The agency does not rule out the possibility of including a \"black box warning\", which gives notice on its most dangerous equipment to draw attention to serious risks.
However, the FDA said in a statement: \"The agency continues to believe that the weight of the scientific evidence currently available does not ultimately prove the association between breast augmentation and the disease of the tissue of the cornea.
\"Cook led several breast implants groups on Facebook, and she said at her home near Dallas that she chose breast implants but had little information about potential dangers.
\"If you sit down with me and say \'This is a list of chemicals you are going to put into your body, you may have lymphoma, and she said: \'I can\'t do this in hell . \".
Her implant is a textured saline model made by French Poly Implant Prothese, used in the United StatesS.
Four years before the FDA implemented stricter breast implant approval standards in 2000.
Under the new regulations, the FDA rejected the company\'s application to sell implants in the United States. S.
After officials visited the company\'s French factory and cited 11 major defects in quality control and manufacturing practices.
In 2010, after doctors in France noticed an unusually high rate of rupture of the implants, Poly Implants went bankrupt and found that the implants were filled by industrygrade gel.
The president of the company was convicted of serious fraud and the French authorities have recommended that tens of thousands of women take out their implants as a precautionary measure.
Cook, 41, said she and other people who had already implanted salt water had never been warned by the FDA\'s actions.
\"When I can try to change the way women are going in the future who are younger than me, I don\'t sit back and feel embarrassed about my decision,\" she said . \".
\"We need to make sure we provide patients with the safest equipment we can possibly provide.
On top of that, we need to make sure she understands the risks before she makes a choice.
\"_ The FDA may now require an identification number on a medical device, but zukman and other advocates point out a big problem with the code associated with breast implants: this number is not actually printed on the implant, but on the package.
\"In most cases, these devices do not cause problems immediately --
They will cause problems in the future, \"said zukman.
\"If these numbers are not in your medical records and are not on the implants, what is the benefit?
\"The unique device identifier (UDI) is designed to help standardize device names and manufacturer information and make it easier to track devices to help recall work and analyze issues.
But if the code is not in the FDA\'s own database, it won\'t work.
The device event at Tomes analyzed the MAUDE data, saying that UDIs is still rarely included in the adverse event report, even if they are included, usually removed from the public data, so they cannot be used to identify a particular device.
\"The whole point of having UDI is that hospitals, providers, insurance companies, and anyone else can say, \'I see a pattern and that\'s all the serial numbers,\'\" said Thomas.
\"But it was edited.
\"Similarly, Tomes and others said the FDA expanded the summary report and used the device registry --
A database funded and maintained by an external organization for tracking a single specific device
In the end, data may be reduced for consumers.
This fall, the agency announced the registration of breast implants through the plastic surgery Foundation to collect patient and equipment data
Including UDI figures for breast augmentation
Allow the surgeon to follow the patient\'s medical history, complications, and follow-upup surgeries.
It is voluntary for plastic surgeons to participate in the registration, and patients can also opt out.
The data collected will be available to doctors and researchers, but not to the public.
As the FDA weighed the expansion of the summary report plan earlier this year, Cook and a dozen other patients with medical device problems as well as patients
The Public Citizen advocacy group urged the agency to reconsider its plans.
But the FDA is on the side of manufacturers and industry organizations who are asking for easier reporting of fault requirements and in some cases they will not submit thousands of individual reports in a year.
According to the new rules now in place, about 90% of devices can report failures every quarter.
\"Every year thousands of consumers are hurt by medical devices, and we are talking about making it easier for us to hide the information we need to make an informed decision, Cook wrote in an objection to the plan.
\"While the goal is not to\" hide \"the data, it is, in essence, what is happening,\" she wrote.
AP health writer Matthew Peron has contributed to the story.
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