An FDA Loophole Prevents Women From Suing Birth Control Maker
A percentage of women using the Essure birth control method are discovering severe side effects, but an FDA loophole is preventing them from suing the products makers.
In 2002 Essure was approved by the FDA as a method of permanent birth control for women who were certain they were done having children. The Essure devices are inserted into the Fallopian tubes and prevent pregnancy, but some of the devices aren't staying where they were put.
A number of women have come to suffer from serious side effects from the product, some even finding their Essure had moved, damaging internal organs along the way.
And yet an FDA loophole is not allowing these women to get any kind of compensation for their pain and suffering.
A spokesperson for Bayer, who makes the product, says that,
The fact is, that the adverse events that have been reported on the news and online about Essure are known and are listed in the Essure product information.
And the product website does contain the following paragraph,
There are rare reports of chronic pelvic pain in women who have had Essure. In rare instances, an Essure insert may migrate through the fallopian tubes into the lower abdomen and pelvis. It may be necessary to surgically remove the migrated device if the patient is experiencing an adverse event.
Still you might think the women would have that surgery to remove the product covered. Not necessarily. Seems because Essure obtained a premarket approval (PMA) from the FDA it means that the FDA was so sure of the safety of the product before it hit the market, they protected it from litigation.
The FDA adds that due to the relatively low number of complaints compared to users of the product, pulling it from the market is not an viable option either.
So of the women who have suffered from using the product have created a closed Facebook group to get the word about Essure out to more women. In fact, Erin Brockvich mentioned the group in a recent appearance on the TV show The Doctors.
If you are searching for a birth control method for yourself and want to know which one may be right for you, the team at Citizens For Citizens Family Planning can answer a wide range of questions.