Concerns Over Essure Removal Complications Increasing Due To Lack of Instructions, Experience
Following stronger warnings about the risk of severe complications with Essure birth control issued by federal regulators, there is growing concern within the medical community about how to safety remove the device, as many women are asking to have the permanent sterilization coils taken out of their body to avoid potential health problems.
Essure is a medical device marketed and sold by Bayer Healthcare, which is designed to provide permanent birth control. It involves an out-patient procedure to implant coils in the fallopian tubes, which cause scar tissue to form and prevent pregnancy. However, thousands of women are now pursuing Essure injury lawsuits and report that they have suffered severe and debilitating problems.
On November 15, the FDA announced new Essure warning label changes, which include a “black box” warning, as well as patient checklist that must be given to women considering the permanent birth control, to ensure they understand the potential risk of complications. However, there remains confusion over what to do when a woman and her doctor decide that Essure needs to be removed.
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According to a report published last week by Modern Healthcare, doctors are often left to improvise on the best way to remove the Essure implant after women begin to suffer complications. The report indicates that there is a lack of instructions on Essure removal, mainly due to the fact that it is designed to be permanent.
Only about 30 doctors nationwide have performed Essure removal procedures, according to the report. The process can be complicated, and carries serious risks of removal complications and health risks.
The Essure coils can reportedly break during removal, leaving pieces behind which could perforate organs and migrate throughout the body. According to one women interviewed for the story, some doctors do not even know what the Essure is, and have to Google it before the removal procedure.
The report recommends that doctors use imaging to ensure the location of the birth control implant first. Bayer recommends doctors cut open the fallopian tube as a part of a salpingotomy, remove the tube altogether, or conduct a cornual resection, which involves removing the cornual part of the uterus to remove the device. These procedures are considered minimally invasive forms of laparoscopic surgery.
The manufacturer’s instructions also suggest a “gentle traction” method of removing the device as a possibility. However, that could cause the coil to stretch and break.
Recently, the FDA reported that it had received nearly 10,000 Essure adverse event reports between the date the device was first put on the market in November 2002, and the end of December 2015.
Of those, 6,989 involved pain or abdominal pain, 3,210 involved unusually heavy or other menstrual irregularities, 2,990 were reports of headaches, 2,159 reports of fatigue, 2088 reports of weight fluctuation, 2016 reports of patient-device incompatibility, such as nickel allergies, 854 reports of device migration, 490 reports that the Essure operated differently than expected, 429 reports that the Essure coils broke, 280 reports that it was difficult to remove, 199 reports of the Essure coils positioned incorrectly, and 187 reports that doctors had difficulty implanting it.
In many cases, reports included multiple complication complaints.
The FDA has also determined that there were four cases of adult deaths, 15 lost pregnancies reported, and two incidents where an infant died after live birth that involved Essure implants. There were also 631 reports of unwanted pregnancies. In 96 cases, those pregnancies were ectopic, which can be life-threatening.
An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002, and the manufacturer now faces a growing number of product liability lawsuits brought by women nationwide, each raising similar allegations that an unreasonably dangerous and defective device was sold for years without adequate warnings or instructions.
As Essure lawyers continue to review cases, it is expected that the size of the litigation will continue to grow over the coming months and years.
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