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FDA’s Black Box Warning Labels Essure as Dangerous Device

March 9th, 2016

The FDA announced on Monday, 2/29 that it will recommend a “black box warning” label for the Essure permanent birth control device. According to the FDA website, a black box warning label is “designed to call attention to serious or life-threatening risks” associated with a prescription drug or medical device. The FDA also instructed Essure manufacturer Bayer Pharmaceuticals to conduct additional studies in order to better understand the risks of prescribing this permanent contraception device to women.

The Essure permanent contraception device was approved by the FDA in 2002 and marketed as a non-surgical, permanent birth control solution for women. Bayer Pharmaceuticals, the manufacturers of the Essure implant, told women that this device would be a safe and effective alternative to laparoscopic sterilization.

According to Reuters, there are more than 500,000 women in the United States that are using the Essure device. Since 2002, the FDA has received more than 5,000 serious injury complaints from women using this device. These women have reported device failures, such as fracturing or migration inside the body, as well as autoimmune responses, such as unexplained but significant weight gain, skin conditions, hair loss and abnormally heavy menstrual cycles.

If you suffered injuries after receiving an Essure implantable sterilization device and want to learn more about your legal options, call The Yost Legal Group at 1-800-YOST-LAW (967-8529). When you call, you will speak with one of our experienced Defective Medical Device attorney absolutely FREE.

The attorneys at The Yost Legal Group are experienced professionals ready to investigate your claim with compassion and determination. Call today for a free consultation.

The Yost Legal Group – Experienced Attorneys Dedicated to Protecting Your Rights

Essure: The Controversy Behind this Female Sterilization Device

In 2002, Bayer released a permanent contraception device called Essure. The device presented women with the option of having two “soft, flexible inserts” implanted through the vagina and cervix into the fallopian tubes in a “gentle, non-surgical” procedure. Bayer promoted this approach as a drastically simpler alternative to the incision and anesthesia necessary for a tubal ligation surgery. The Essure coil-like inserts were designed to generate scar tissue to block the fallopian tubes, without releasing…

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When making an important purchase, such as a mobile device or a vehicle, there are many factors that help in your decision making process. It is important to consider the potential safety risks associated with any product that you purchase. As consumers, we put our faith in manufacturers to deliver safe products and we trust our government agencies for making companies abide by strict safety and manufacturing guidelines. But this is not always the case….

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When the stomach produces too much gastric acid, it can enter other parts of the body such as the throat and cause irritation, ulcers and other damage. This burning sensation in the throat or upper chest, which is often referred to as acid reflux or heartburn, impacts millions of Americans. In fact, the National Institute of Health estimates that about 20% of Americans are affected by symptoms of acid reflux and heartburn. New scientific evidence…

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The Food and Drug Administration (FDA) is warning consumers to avoid “Bentonite Me Baby” by Alikay Naturals due to a risk of lead poisoning. “Bentonite Me Baby” is marketed as medicinal clay that can be ingested or applied topically for the treatment of several conditions. However, safety testing of this product revealed that that “Bentonite Me Baby” tested positive for elevated levels of lead. Read more about this product warning here.

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