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Chicago defective medical device lawyersOver the last decade, an estimated 750,000 women have received the Essure birth control implant. Thousands have reported health complications, some of which were life-altering. In response, the U.S. Food and Drug Administration has moved to issue a “black box” warning – their most serious type – for Essure. Yet the devices remain on the market. If you or someone you love has the Essure implant, the following information covers what you should know about the possible risks, and what you can do, should you experience any of them.

Current Warning Label and Potential Complications

Pitched as the only non-surgical permanent birth control option, Essure consists of two nickel-titanium coils. They are implanted into the fallopian tubes, through the cervix, during a 15-minute procedure. Within three months, scar tissue is supposed to develop around the coils, preventing the fallopian tubes from releasing eggs into the uterus. Until a follow-up check at that three-month mark, women are told to use alternative forms of contraception to prevent pregnancy. The device’s current warning says women may experience pelvic pain and bleeding immediately after the procedure.

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tort reforms, Chicago product recall attorneysThere was a time when corporations cared about their products and the effect they had on the general population. It was a time when companies worked hard to prevent the distribution of defective products; when the system failed and a defect did make its way to the public, the issue was quickly rectified. In some ways, it is an indication of just how much values have changed over the years, but it is an even stronger indication of how the decisions made by lawmakers, legislators, and courts have diminished the sense of accountability for large corporations.

Punitive Damages and Corporate Accountability

Punitive damages and corporate accountability go hand-in-hand because, when a corporation has the fear of being hit with damages above and beyond just the typical damages, they are less likely to gamble with the lives of their consumers. But punitive damages have become nearly non-existent, with some states placing caps on the amounts and others doing away with them altogether. As a result, corporations have begun to weigh the cost of continuing to produce defective products against the cost of correcting the problem or pulling the product altogether.

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infant medical device recall, Chicago product liability attorneyPhilips Healthcare initially recalled its Gel-E Donut and Squishon 2 medical devices in May 2014 after visible mold was detected on the outer surface of the products. This recall was for devices distributed from July 2012 to December 2013.

As of October 2014, the Food and Drug Administration (FDA) reported a Class I recall issued by the same manufacturing company for the same devices. These gel-filled products are used under supervision in hospitals to support an infant’s head and body. The following models have been recalled:

  • Gel-E Donut 92025-A;
  • Gel-E Donut 92025-B;
  • Gel-E Donut 92025-C; and
  • Squishon 2 91033-2.

The second recall included products manufactured from July 2012 through to August 2014. The defective devices prompted 12 new complaints of visible mold within just four months of the initial recall. Cladosporium and Penicillium Fungi were two of the molds identified, which can cause:

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