Defective Medical Products Comments Off on FDA To Review Essure Birth Control Amid Mounting Concerns
Federal regulators have said they will hold a public meeting to review scientific data regarding the safety and effectiveness of birth control device Essure.
According to an NBC New York news report, officials with the U.S. Food and Drug Administration (FDA) have said they will hold the meeting after media reports uncovered inconsistencies in a clinical trial survey used to win FDA approval for the birth control device.
Reports of Problems
Essure is a device that was approved by regulators in 2002 and is manufactured by pharmaceutical company, Bayer.
It basically consists of two metal coils that are inserted into a woman’s fallopian tubes to create a permanent barrier to conception.
Since the device was approved, FDA has documented more than 5,000 reports of medical problems linked to Essure ranging from headaches and fatigue to weight gain and severe abdominal pain.
In more than 400 cases, patients or doctors reported that Essure coils migrated from the fallopian tubes to other parts of the reproductive system.
In five cases, it was reported that fetal deaths occurred after the device failed to prevent pregnancy.
So far, in the United States, about 750,000 women have been implanted with the device, which would amount to one complication for every 150 patients.
In 2013, NBC’s I-Team secured records, which showed that an Essure clinical trial patient reported pelvic discomfort or pain seven times during eight years of follow-up.
In spite of that, clinical trial researchers reportedly marked the woman’s comfort level as “excellent.”
Responsibility of Manufacturers
Medical device manufacturers have a legal obligation to conduct clinical trials and review the results of those trials truthfully before the products are marketed or sold.
As product liability lawyers who represent victims of defective medical devices, we will be closely watching this FDA hearing to see what the panel found and what the facts are with Essure.
Manufacturers who deliberately hide information from consumers or post misleading information so consumers will buy their products, should be held accountable for their wrongdoing.
If you have suffered adverse health effects as a result of using Essure or any other defective medical device, it is crucial that you obtain the information necessary to protect your legal rights.
You may be eligible to receive compensation for damages including medical expenses, lost wages, hospitalization, pain and suffering and emotional distress.