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Developed by Conceptus Inc., a subsidiary of Bayer, Essure® is a permanent, non-surgical birth control device that was first introduced to the market in 2002. Part of the appeal of the device is that it is a non-hormonal birth control method that does not require any surgery or anesthesia, and can be inserted within minutes in the comfort and convenience of a physician’s office. After insertion, the patient’s tissue is supposed to grow around the metal coils of the device over a period of three months, forming a blockage in the fallopian tubes that prevents conception.
Unfortunately, there have been thousands of reports that the device has caused injury to patients who were not made aware of the high risk of side effects. Between 2002 and 2015, the FDA has received nearly 5,100 reports of problems related to use of the device. There are now hundreds of lawsuits pending throughout the country alleging that the manufacturer and seller of the device concealed evidence of various risks from the Food and Drug Administration in order to wrongfully obtain Premarket Approval. Furthermore, the manufacturer has failed to properly warn physicians and patients of these risks, continuing to allow women to suffer harm.
Essure Side Effects & Risks
Use of Essure has been linked to the following adverse effects:
- Chronic pain
- Abnormal bleeding
- Unplanned pregnancy, including high-risk ectopic pregnancy
- Stomach and pelvic device migration
- Puncturing of the uterus and/or fallopian tubes
- Rash, itching, and hives due to a possible nickel allergy
Because the device was not intended to be removed, women who have experienced severe side effects, or whose device has broken, may face multiple surgeries to attempt removal. If this is not successful, surgery to remove the entire uterus becomes necessary.
ESSURE LAWSUIT ATTORNEY IN ATLANTA, GA
Despite the clearly risky nature of this product, the manufacturer has not announced any recalls of Essure devices. The FDA has, however, had a meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss patient’s experiences with the device alongside scientific and clinical opinions. The FDA is expected to complete a review in early 2016 and announce its next steps for managing the device.
If you or someone you know has suffered harm in connection with the Essure contraceptive device, please call Schneider Hammers and speak with an Atlanta personal injury lawyer today. Because there is only a two-year statute of limitations in Georgia, time is of the essence in getting the help you need. Our seasoned legal team may be able to help you recover compensation for the losses you have sustained through use of the device, including pain and suffering, past and future medical bills, lost wages, and more. We have handled countless dangerous medical device cases in our years of experience and are not afraid to take your case to court in order to obtain the best results possible.