Filed Allegations By Iowa Couple From Serious Injury. A new Essure injurylawsuit has been filed by an Iowa couple over allegations that the wife suffered serious injuries due to implantation with the permanent birth control device, which is manufactured by Bayer HealthCare. The Essure lawsuit was filed in the U.S. District Court of Southern Iowa, Des Moines Division.
Essure is constructed with two metal coils that are implanted through the vagina and into the fallopian tubes. The body reacts with an inflammatory response that slowly builds scar tissue around these coils, which creates a barrier in the fallopian tubes that prevents sperm from fertilizing an egg. The Essure device received U.S. Food and Drug Administration (FDA) in late 2002.
Essure complications have been reported since shortly after approval with women have reported suffering from device failure that has led to pregnancy, fatigue, headaches and migraine, heavy bleeding, metal allergies, nausea, organ perforation, and severe depression and suicidal thoughts, to name some.
In this case, the couple alleges that Bayer HealthCare failed to warn consumers about Essure’s potential adverse side effects. Allegations also include that the injuries the wife suffered included uterine perforation, hepatomegaly (abnormal enlargement of the liver), and infection.
The couple alleges these injuries are due to Essure and that the wife chose Essure after reviewing Bayer’s advertisements and discussing the permanent birth control with her physician.
Woman Sufferd Complications From Unawareness of Safety Warning
When the woman underwent Essure implantation, her physician was not aware of the potential Essure injuries she could suffer. She alleges that the complications she experienced were not listed on Essure’s warning label, and Bayer did not provide any precautions or relevant studies.
Essure is touted as an alternative to other birth control options that are invasive or complicated, such as tubal ligation. Since Essure received FDA approval, the agency has received over 4,500 Essure adverse event reports.
Allegations include that Bayer HealthCare allegedly knew of Essure complications, but did not disclose that information to protect Essure’s market value. Also, as a result of this alleged negligence, the couple in this case say their lives have been permanently altered, including allegations of severe impact to their marriage as a result of the woman’s Essure injuries. The husband is also filing for loss of consortium as well as multiple counts of negligence.
Essure was cleared through the FDA’s fast review process. This has led consumer advocates to urge for Essure’s removal from the market. Essure opponents also say that Bayer has attempted to use pre-market approval rules to avoid liability in its manufacturing of the allegedly defective product. To date, thousands of women have filed lawsuits against Bayer alleging that Essure caused serious complications.
In 2015, the FDA convened an advisory panel to discuss Essure’s risks and benefits. The independent panel of experts concluded that there was not enough data to show that Essure is safe, and found that its use should be limited.
The FDA has since added a so-called “Black Box” warning, its most severe warning, on the label of Essure devices cautioning physicians and patients of serious side effects associated with the use of the Essure fertilization method.
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