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A lot has been noted about the dangers of transvaginal mesh implants, most commonly used for pelvic organ prolapse repair and/or stress urinary incontinence, according to the U.S. Food and Drug Administration (FDA). Transvaginal mesh is only one type of surgical mesh used however—a device generally implanted to “repair weakened or damaged tissue.” Another common use for surgical mesh devices is for the repair of hernias. Hernia repair, according to the Wall Street Journal, is “one of the most common surgical procedures [yet it] carries a risk many patients don't consider: chronic pain after surgery.”

According to the Wall Street Journal, more than one-third of patients who undergo hernia repair suffer “long-term chronic pain and restricted movement after surgery.” This type of pain is similar to that experienced by women who have had transvaginal mesh implants, but because a hernia operation is a much more common procedure, this type of device affects more patients. Synthetic mesh, “though better than traditional sutures at reinforcing the abdominal wall, can irritate nerves and carry a slightly higher risk of infection,” according to the Wall Street Journal.

According to a different report issued by the FDA, the use of surgical mesh implants to repair hernias has increased steadily since the 1980s. “By 2000,” the FDA reports, “non-mesh repairs represented less than 10 percent of groin hernia repair techniques.” The risks associated with surgical mesh implants for hernia repair have spurred a couple product recalls—one is the Bard Composix Kugel Mesh Patch, another is one in which a counterfeit material was used.

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If you have ever experienced painful side effects due to a defective medical device, drug or vaccination, you are not alone. Consumer Reports notes that “tens of millions of Americans live with medical devices implanted in their bodies,” including artificial joints, heart defibrillators and surgical mesh. And while Americans may assume that these devices have been tested for safety and effectiveness, Consumer Reports indicates that this is rarely the case. However, there is a free mobile app that allows you to report any device or drug problems and complaints directly to the FDA.

The MedWatcher app, available in both the Apple iTunes and Google Play stores, is the only app that allows users to track and report negative side effects, obtain recalls, and receive government safety alerts. Users also receive reports of the side effects submitted by other users, thus helping to make medical products safer for everyone.

The FDA encourages healthcare professionals, patients and caregivers “to report serious adverse events that might be associated with a medical device, especially events that are not listed in the product labeling. 'Serious' means fatalities, hospitalizations, and medically significant events.” Reports of therapeutic failures where devices failed to work properly, uncertainties in product names, directions for use or packaging, and other product quality issues such as “suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging” are also encouraged to be reported.

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USA Today published a stunning report that reveals that, across the country, there are thousands of doctors who are forbidden to practice in hospitals or other medical establishments, yet have not received any kind of punishment from state medical boards. Those doctors, despite having settled multiple medical malpractice suits, still maintain their medical license.

The publication collected data and statistics from multiple sources, including the National Practitioner Data Bank. The law mandates that any “adverse action” filed against a physician must be reported to the data bank – the intention being that the data bank would be closely watched by the state boards. Other sources of information were hospital disciplinary records and malpractice payment records.

The investigation revealed that almost 6,000 physicians had clinical privileges revoked between the years 2001 and 2011. But astonishingly, more than half of these same doctors never received any kind of discipline or reprimand from their state licensing boards. No fines, restrictions, suspensions or revocations were issued against these doctors.

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Every year, defective medical devices affect thousands of Americans and the problem only seems to be growing, according to Consumer Reports. Medical devices that are implanted into bodies (including but not limited to defibrillators, surgical mesh, and artificial joints) often go untested. “For most implants and other high-risk devices brought to the market,” Consumer Reports claims, “manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue.” Sometimes the only testing that occurs, according to Consumer Reports, is in the bodies of patients who undergo treatments or surgeries thinking that the product has already undergone an extensive testing phase.

Some meta organizations have called on the FDA to change, or at least tighten, their approval process in an effort to curb the number of cases of people dealing with the effects of a defective medical device. In 2011, according to Consumer Reports, “a panel from the prestigious Institute of Medicine said the FDA should overhaul its device regulatory system because it fails to ensure patient safety before and after products go on the market.” This is not only because many medical devices end up in the market without having undergone testing, it's also because “there's no systematic way for the government, researchers, or patients to spot or learn about problems with devices.” This is because medical devices don't often have serial numbers the way even common appliances, such as toasters, do. According to the FDA, the Center for Devices and Radiological Health “is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States.” Medical devices are classified into three categories, and regulatory control increases with the level of classification. In 2012, Congress passed legislation that helped to loosen controls of regulation through the FDA Safety and Innovation Act, which included Medical Device User Fee Amendments.

If you or someone you know has been affected by a defective medical device, the most important step is to contact an experienced defective medical device lawyer today.

The metal-on-metal hip replacements that have caused such a catastrophe for so many U.S. patients have been banned in the U.K., according to the Daily Telegraph. According to the U.S. Food and Drug Administration (FDA), there are always risks associated with hip replacements, and metal on metal (MoM) hip replacements carry additional risks unique to MoM hip implants. “In MoM hip implants,” states the FDA, “the metal ball and the metal cup slide against each other during walking or running. Metal can also be released form other parts of the implant where the two implant components connect.” The release of the metal, states the FDA, will eventually cause some small particles to rub off the implant and can cause the implant to slip. There's also the risk that “some of the metal ions (e.g. cobalt and chromium) from the metal implant or from the metal particles will enter the bloodstream,” according to the FDA.

It wasn't until late October of this year, after “a study found unacceptably high failure rates among implants in 17,000 patients,” Daily Telegraph, that the National Health Service (NHS) in the United Kingdom decided to ban NHS hospitals from using MoM hip replacements. Two models were immediately taken off the market, “and thousands of patients fitted with the implants have been told to have annual checks, often including blood tests,” reports the Telegraph. The blood tests are meant to measure whether or not toxic levels of metal had leaked into the bloodstream of patients fitted with the MoM replacement.

The warning in England didn't come until the National Institute for Health and Care Excellence found that the MoM devices were failing in as many as 43 percent of patients. “One device,” according to the Telegraph, “the DePuy ASR, which was withdrawn when manufacturers admitted to failure rates of 13 percent within five years, required revision surgery in almost a quarter of cases within that period.”

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