by PR Newswire
The Street
'Lawsuit website reports that the FDA recently announced that even though the device is still on the market, the Essure birth control implant will receive a "black box" warning in order to alert doctors and patients to the problems that have been reported by thousands of women.' - PR Newswire
NEWARK, N.J., March 9, 2016 /PRNewswire/ -- MT Services LLC, a Lawsuit Settlement News Reporting Company which operates lawsuitsettlementnews.com, announced today that the FDA recently announced that the Essure contraceptive implant will receive a "black box" warning on it to alert doctors and patients to the problems that have been reported by thousands of women. Although the device is still on the market, thousands of complaints have been reported by female patients, stating the device resulted in complications such as chronic pain, bleeding, and other health problems.
Essure has been on the market for more than a decade. Bayer Healthcare Pharmaceuticals, Inc. is the manufacturer. According to NBC News online, Essure "is frequently pitched to women as the only non-surgical option for permanent birth control," and "consists of two nickel-titanium coils inserted into the fallopian tubes, where they spur growth of scar tissue and block sperm from fertilizing a woman's eggs." However, the FDA reported that "some women may be at risk for serious complications."
Since 2002, approximately 750K women have been implanted with the Essure implant, and a number of them have had to have surgery to replace or remove the device. Potential complications and side effects include the following:
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- Damage to the uterus and fallopian tubes (if device shifts)
- Pelvic pain
- Irregular bleeding
- Unplanned pregnancy
- Mood disorders
- Weight gain
- Hair loss
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