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Bayer may have concealed side effects of possible defective drug

A number of women in California use birth control for various reasons, but according to the FDA, one popular form of contraception may not be as safe as previously thought. Bayer Healthcare Pharmaceuticals Inc. is under investigation by the FDA, following allegations that the company might not have been honest about certain clinical trial results. The altered results may reveal that Essure is actually a defective drug

Although Bayer continues to defend the safety and efficacy of Essure, there are many who disagree. According to the FDA, Essure can cause potentially catastrophic side effects, including perforated bowels. The device -- which is supposed to remain in place in a woman's fallopian tubes -- has also been found to migrate to other parts of the body. While Bayer did disclose 22 incidents of perforation, there were apparently an additional 168 of which they were aware. Additionally, Bayer allegedly held on to over 16,000 Essure-related complaints without ever revealing this information to outside sources.

Bayer further made claims that it was apparently unable to support. It claimed that Essure's effectiveness was even higher than that of alternative forms of permanent birth control, such as tubal ligations. However, multiple pregnancies occurred during clinical trials of the birth control, and in an eight year period over 60 pregnancies while using Essure were reported to the Bayer. This information was not made available to consumers.

When women in California need to choose the form of birth control that is most appropriate for them, having all relevant information -- including possible side effects and overall efficacy of the medication or device -- is necessary in order to make the most informed decision possible. Unfortunately, when companies purposely conceal vital information from the FDA and the public, a defective drug can make its way into medicine cabinets across the nation, causing serious injury to the patients who rely on it. Although an investigation by the FDA is not a necessary prerequisite to filing a product liability claim against a company that manufactured or produced a defective drug, any relevant information that is uncovered can be useful for navigating a successful settlement.

Source: medscape.com, "FDA to Investigate Bayer's Essure Contraceptive Device", Troy Brown, April 3, 2015

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