Twenty-four women have come together to file a joint Essure lawsuit citing deception by manufacturer Pfizer in reporting side effects associated with the birth control. The litigation follows a report claiming that Bayer did not report about two-thirds of adverse events linked to the contraceptive to the FDA. Consumer groups, women activists, and other grassroots movements continue to urge the regulator to withdraw Essure birth control device citing perforation injuries and inability of the device to check unwanted pregnancy.
According to the Essure lawsuit filed in a Pennsylvania district court, the failure of Bayer to report unwanted pregnancy, uterus problems, and other risks of Essure side effects led plaintiffs to believe that the birth control was a safer alternative. However, these women experienced painful and debilitating Essure injuries, including fetal deaths, uterus perforations, unwanted pregnancies, and hysterectomies. Their Essure attorney argues that the manufacturer purposefully withheld and did not report “adverse events submitted by women nationwide” to conceal design defects in the birth control coil and further its commercial gains.
The Essure lawsuit pointed out 2013 FDA finding of 16,000 complaints involving the contraceptive on an internal document that was never reached the regulator. A large number of these adverse events highlight migration of the birth control device outside the fallopian tube. Details submitted by the concerned Essure attorney also showcase that though Bayer was aware of at least 144 uterus perforation incidents, only 22 found their way to the FDA. No adverse events involving the contraceptive migration or breaking down was ever reported. Making the matters worse, the manufacturer made no assessment of the quality, safety, or Essure side effects. It defended the non-reporting saying that these are “mere trial damage that does not rise to the level of a serious injury” and most complainants did not experience long-term pain.
An independent analyst has gone a step further and claimed that Bayer “mislabeled” 300 side effect incidents reported to it between August 2015 and February 2016 to keep them concealed. All these Essure injury reports were categorized as “filed by others” instead of medical practitioners to avoid their reporting to the FDA. In March, the federal regulator announced a “black box warning” on Essure contraceptive device to highlight “serious or life-threatening risks.”
Essure Side Effects
The recent surge in the filing of Essure lawsuits across the United States indicate that extent of injuries linked to the birth control device. Between November 2002 and May last year, at least 5,000 Essure injury complaints were reported directly by users through the MedWatch. These figures exclude thousands of adverse events the manufacturer informed of.
The most reported Essure side effects are:
- Contraceptive migration
- Uterus perforation
- Birth control coil breaking down into pieces
- Damage to reproductive organs
- Unwanted pregnancy
- Nickel poisoning
- Abdominal pain and cramping
- Vaginal bleeding
- Pelvic pain and inflammation
- Neurological side effects, such as fainting, memory loss, depression, foggy head
- Hot flashes
- Hair loss
- Design defect cause incorrect placement
Essure birth control has also been linked to fetal death traced to nickel poisoning and leaching. The chemical coating on the device releases toxic elements and this causes scar tissue formation, inflammation, and other complications, including postnatal mortality in case of unwanted pregnancy following the implant migration. The lack of training for inserting the complex birth control coil puts users at the risk of device migration and reproductive organ perforation. Those with perforated uterus and fallopian tubes have the greater chance of miscarriage when they conceive unknowingly after Essure migration.
Contact our Essure attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuit seeking compensation and damages for suffering from complications associated with the birth control device.