Four Deaths, Severe Injuries, Linked to Essure® Contraceptive Device
Posted on behalf of D'Amico & Pettinicchi, LLC on Feb 01, 2016 in Product Liability
After thousands of complaints about severe health problems, Congress has introduced a bill to withdraw Essure, a contraceptive device sold by Bayer®. Women across the country have reported severe allergies, organ perforation and other health problems after using the contraceptive.
At least four adult deaths have been linked to the device, along with five fetal deaths.
A group of women harmed by the device have banded together in a Facebook community called "Essure Problems," to share their stories, and pressure the government to act.
Essure Device Problems
Essure is sold as a permanent birth control device, intended as an alternative to tubal litigation (getting your "tubes tied.")
The flexible metal device does not require surgery, but is inserted into the fallopian tubes after being coiled through the vagina and cervix. Once inserted, scar tissue grows around the device, creating a barrier to keep sperm cells from reaching the eggs, thereby preventing contraception.
Since the device was first introduced in 2002, the Food and Drug Administration has received 5,093 medical device adverse reports, citing a variety of health issues. Some of the issues associated with Essure include:
- Perforation of the uterus or fallopian tubes
- Irregularities in menstrual cycles
- Severe abdominal pain
- Nickel allergies causing severe skin rashes and itching
- Hair and tooth loss
- Detachment of the device from the fallopian tubes
- Severe backache and pelvic pain
In addition, hundreds of unintended pregnancies have been reported, bringing into question the device's effectiveness.
Pre-Market Approval Shields Manufacturers from Liability
An article published last October in The New England Journal of Medicine gave an overview of the problems with the medical device, stating "…the evidence suggests that it is neither as effective nor as safe as the pre-marketing-approval evaluation indicated."
The author suggests the pre-marketing approval, or PMA, process itself is flawed and Essure is only one of many devices that may have been rushed to market without adequate testing or post marketing follow-up studies.
To add insult to injury, having pre-market approval may shield medical device manufacturers from civil litigation, thanks to the 2008 Supreme Court decision in Riegel v. Medtronic.
In addition to a bill to remove Essure from the market, titled the "E-Free Act," U.S. Representative Mike Fitzpatrick from Pennsylvania is proposing legislation that would overturn Riegel v. Medtronic and remove all barriers to civil litigation in medical device liability cases.
This bill, and the consumer's movement against Essure, demonstrate a growing pushback against industry lobbyists and the tort reform movement.
The right of consumers, who have been harmed, to seek recourse in the courts is a basic tenet of our justice system. Equal protection under the law is a Constitutional guarantee under the 14th amendment.
If you or a loved one has been harmed by a defective medical device, the product liability attorneys at D'Amico & Pettinicchi will work with you to pursue justice. Contact us today for a free case review.