Women who have suffered severe abdominal pain and multiple adverse health issues from the use of the Bayer’s Essure birth control device have had support for their impending lawsuits from a recent court decision in Philadelphia. This decision has allowed five women to proceed with their lawsuits against the company, despite Bayer’s attempts to have the litigation stopped. The progress of the litigation will be watched with great interest by thousands of women across the country who have filed similar lawsuits.
What Is Essure Supposed to Do?
The Essure birth control device was originally designed and manufactured by a company called Conceptus Inc. The company got pre-release approval from the U.S. Food and Drug Administration (FDA), and thousands of the devices were sold and installed by doctors before the company was bought by Bayer Health Care, which still controls the sale and distribution of the product today.
The device is intended to be a one-off permanent birth control device which is capable of being inserted into a woman’s fallopian tubes in a simple operation that can be performed in a doctor’s office. The device consists of a metal coil that unfolds inside the fallopian tube and blocks sperm from fertilizing any eggs that are released from the ovaries during the menstrual cycle. Eggs are still released, but die and become absorbed because they are not fertilized. Bayer continues to claim that the use of the device is safe and is almost completely effective as a contraceptive.
Many women have had the Essure device inserted as an alternative to other permanent methods of contraception such as tubal ligation. In fact, the procedure, like tubal ligation, is potentially reversible, but the risks of doing so are quite high and the surgery involved is much more complicated than inserting them in the first place.
What Are The Problems Reported Form Using Essure?
Of the 750,000 women who have reported having had Essure devices inserted in them, thousands of them have reported abdominal pain and other symptoms. Some of these women have reported serious side effects and there have been a few fatalities. A FDA panel was convened in 2015 to review complaints about the device, and Bayer detailed 20,000 reports of problems listed on social media sites like Facebook and Twitter. The FDA received over 5,090 complaints made voluntarily to the agency up to 2015.
The Adverse Medical Complaints Include The Following:
- Abdominal pain
- Heavier than usual periods
- Weight fluctuation
- Device incompatibility
- Device migration inside the body
- Device breakage
The FDA has reported a known 5 cases where fetuses have died from the use of the device and four women have died from air embolism, infection, uterine perforation and suicide.
Early Stumbling Blocks to Litigation and an Early Lawsuit is Filed
Bayer has claimed that lawsuits are not possible because of a pre-emption clause in the medical Device Act (MDA). This basically prevents lawsuits from being filed if the FDA has already issued approval before a medical device is approved. However, this didn’t stop Florida woman Heather Walsh filing a lawsuit against Bayer in 2014, claiming that the company did not give sufficient instructions to doctors to be able to insert the device correctly. She maintained in the lawsuit that she suffered severe health problems because the device was not correctly implanted by her doctor and therefore the lawsuit is not so much a defective product lawsuit but one of malpractice on the part of Bayer.
Litigation Allowed to Proceed in Philadelphia
The most recent litigation brought by five women in Philadelphia against Bayer Health Care has been allowed to proceed in a ruling by Judge John R. Padova in the U.S. District Court in Philadelphia. Although the judge rejected many of the women’s claims against the company, he permitted two of them to proceed to trial. These were that “the company used misleading advertising” and “that it failed to warn women against the risks of using Essure”.
Lawyers representing the five plaintiffs are pleased with the progress through the District Court and expect to go ahead with discovery in the pre-trial period. Many thousands of other women across the country and their legal representatives will be watching this litigation very closely.
If you have suffered negative health effects from using Essure, contact our birth control lawyers today for a FREE Consultation to determine if you may be entitled to reimbursement for your loss. Call (855) 552-2337 24 hours a day, 7 days a week.
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