The FDA And MAUDE Reporting System Are Under Fire For Under Reporting Adverse Events

Experts and FDA insiders believe that the agency may have colluded with medical device manufacturers to publically underreport the number of adverse events in which the public has access

Monday, May 27, 2019 - Shocking and potentially game-changing investigative reports by several reputable investigative news websites have uncovered evidence of potential fraud on the part of the US Food and Drug Administration (FDA) as it pertains to providing public access to the agency's medical device records. It appears as if the US Food and Drug Administration (FDA) may have allowed medical device manufacturers to hide adverse event reports within the agency's MAUDE adverse event reporting database and away from public scrutiny. Kaiser Health News (KHN) reports that the FDA has created a "hidden database" that filters out certain adverse events keeping them from the public. "... the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines." Essure birth control lawsuits handled by top national attorneys helping families and individuals by answering questions in regards to Essure birth control lawsuits and offer a no obligation free consultation before filing a claim.

The FDA has a history of playing loose when it comes to reporting adverse events caused by medical devices in the past. Based on what was then considered internal FDA ineptitude, former IT manager Madres Thomes quit her post at the agency and founded a company called Device Events.com which uses an advanced search algorithm developed by Madres to more fully uncover reports of medical device failure. Such was the case a couple of years ago when Madres reported that she had uncovered over 300 fetal deaths caused by the Essure birth control device, not the official FDA and Bayer admission of only three.

Madres has been in Washington DC this past week to support Essure women that have been harmed by the device. The Madres algorithm was expanded to include ectopic pregnancies, those outside of the uterus, where the only possible outcome is to abort the pregnancy, and miscarriages. Madres and others are lobbying for passage of the Medical Devices Safety Act. In addition, The Implant Files.com reports that the FDA has been exceptionally lax in requiring the makers of Essure to fulfill their obligation to report complaints that come into the company. "In 2011, the U.S. Food and Drug Administration discovered that more than 16,000 complaints related to Essure had poured into the device's manufacturer, Conceptus Inc., between January 2008 and December 2010. But in the same period Conceptus (which has since been acquired by Bayer AG) filed only 182 reports of patient harm with the FDA, the agency found."

The shortcomings of the US FDA pertaining to its approval and regulation of the multi-billion dollar medical devices industry has been brought to light in the Netfix.com documentary "The Bleeding Edge" where a former FDA chairman-turned-whistleblower has exposed the agencies lack of testing medical devices before rushing them to market, often resulting in chains of medical device approval based on a faulty or recalled medical device, to begin with. On March 5, 2019, the Washington Post reported that "FDA Commissioner Scott Gottlieb abruptly resigned from his post. That was unexpected, including by the FDA, apparently. FDA Commissioner Scott Gottlieb resigned today, an administration official said."

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The FDA And MAUDE Reporting System Are Under Fire For Under Reporting Adverse Events

Experts and FDA insiders believe that the agency may have colluded with medical device manufacturers to publically underreport the number of adverse events in which the public has access

More Recent Essure Complications Lawsuit News:

Essure Lawsuits: No Fees Unless We Collect for You

No-Cost, No-Obligation Essure Lawsuit Case Review If You or a Loved One Suffered from Essure Problems