Essure Injury Lawsuit Filed By 25 Women Who Suffered Devastating Complications
A group of 25 women recently filed a joint lawsuit over complications from Essure birth control, each involving a severe and debilitating injury allegedly caused by the permanent sterilization procedure.
Essure is designed for women who want permanent birth control, involving the placement of bendable coils into the fallopian tubes. The procedure causes scar tissue to form around the coils and block the tubes.
Although it is marketed as a safe and effective means of preventing pregnancy, thousands of women have reported suffering an Essure injury in recent years.
The complaint (PDF) was filed in the U.S. District Court for the Eastern District of Pennsylvania earlier this month, involving claims by 25 different women who experienced severe pelvic pain, infections, incontinence, tingling in the extremities, blurred vision and other problems allegedly caused by the Essure procedure.
Many of the women involved in the lawsuit indicate that they required a hysterectomy due to the Essure injury, claiming that the device was defectively designed and that Bayer failed to adequately train physicians on how to properly implant it or remove it when the coils migrates out of position. The complaint also indicates that the manufacturer provided doctors with hysteroscopic equipment used in the implanting procedure without proper training.
“Defendants ‘handed out’ this equipment to unqualified physicians, including Plaintiffs’ implanting physician, in an effort to sell its product,” the lawsuit states. “Defendants knew or failed to recognize that the implanting physician was not qualified to use such specialized equipment yet provided the equipment to the unqualified implanting physician in order to capture the market.”
The case joins a growing number of Essure injury lawsuits filed in recent months, each involving similar allegations that Bayer failed to adequately warn about the risk of problems and withheld information from consumers, doctors and federal regulators.
Last year, the FDA held advisory panel meetings to review the safety of Essure. After considering recommendations from the panel of outside experts, the FDA announced in late February 2016 that much stronger Essure warnings will be required to make sure doctors and women are informed of the potential risks.
Although the product has been sold for the past 14 years, Bayer has also been ordered to conduct additional studies to better understand the safety of the Essure implant, raising questions about why the manufacturer failed to take these steps years ago after receiving complaints.
An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.
As Essure injury lawyers continue to review and file potential cases for women nationwide, it is ultimately expected that Bayer could face hundreds, if not thousands, of lawsuits in courts throughout the U.S.
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