Essure Lawsuit Help
The Weinberg Law Firm is currently assisting individuals injured by Essure, a permanent birth-control implant, after the FDA received more than 5,000 reports of complications from the device, including chronic pain, bleeding and allergic reactions, since the device was approved in 2002. According to the FDA, Essure was insufficiently labeled to warn women of the serious risks associated with the device.
Obtain A Free ESSURE Lawsuit Case Evaluation
If you are a loved one has been seriously injured by an Essure sterilization device, and you have a question concerning your legal rights, please submit our easy-to-use “Legal Case Evaluation Form”, or contact us toll free at 1-877-934-6274 for a free Essure lawsuit case evaluation.
The Weinberg Law Firm is currently assisting individuals injured by medical devices, including vaginal mesh, power morcellators, IVC filters, and endoscopes/duodenoscopes as well as other devices. Mr. Weinberg also serves as local counsel for mesh lawsuits filed against manufacturers C.R. Bard and Johnson & Johnson consolidated in New Jersey Superior Court in Bergen County.
Essure Complications
Several serious adverse events have been reported, including:
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• persistent pain,
• perforation of the uterus and/or fallopian tubes,
• intra-abdominal or pelvic device migration,
• abnormal or irregular bleeding,
• allergy or hypersensitivity reactions.
Due to these complications, some women have had surgical procedures to remove the Essure. In other cases Essure failure has occurred due to incomplete patient follow-up, leading to unintended pregnancies. Because part of the device is made from a nickel-titanium alloy, patients with a nickel allergy may have an allergic reaction to the device, including rash, itching and hives, Bayer has said.
What Is Essure And How Does It Work?
Essure, manufactured by Bayer, is a permanent (irreversible) form of birth control, meaning a woman who gets the device will no longer be able to become pregnant. Studies have shown that if the device is correctly implanted, the chance of pregnancy is less than 1 percent, the FDA said. About 750,000 women have received Essure since 2002, according to Bayer.
Unlike the traditional method of female sterilization, (known as “getting your tubes tied”), implanting Essure doesn’t require surgical incisions. This form of female sterilization is preferable for some women as this method does not require a surgical incision. The implantation procedure for Essure involves flexible coils, placed by a health care provider, through the vagina and cervix and into the fallopian tubes. Tissue then forms around the inserts; this build-up of tissue creates a barrier that keeps sperm from reaching the eggs. This procedure permanently prevents conception. There is no alternative permanent form of birth control for women that doesn’t require surgical incisions.
What Is The FDA Doing?
In consideration of the risks associated with the Essure method, the FDA announced a plan for additional studies and increased patient awareness of the device complications. The FDA issued a “new, mandatory clinical study for Essure to determine heightened risks for particular women. […] The FDA has also ordered Bayer, the company that manufactures Essure, to conduct a new postmarket surveillance study designed to provide important information about the risks of the device in a real-world environment.” In order to insure that patients and health professionals are aware of all issues, the FDA published plans to require changes to product labeling, such as a boxed warning and a “Patient Decision Checklist” to help to ensure women receive and understand information regarding the benefits and risks of this type of device.Help
