FDA Approved Medical Device Being Blamed For Countless Injuries, Medical Conditions

By Mike Dougherty

PHILADELPHIA (CBS) -- Congressman Mike Fitzpatrick is calling for the Food and Drug Administration to ban the use of a medical device that's been the source of tens of thousands of complaints.

Essure is implanted into the fallopian tubes for permanent sterilization, but women are reporting widespread complications and even death.

Essure has an FDA gold stamp of approval, but Congressman Fitzpatrick says it's responsible for more than 300 fetal deaths and countless other medical complications.

It goes deeper. Fitzpatrick says kickbacks from Bayer, the manufacturer provided illegal financial incentive to doctors.

"The manufacturer is providing free marketing and advertising services to OB/Gyn. They were encouraging them to use Essure on their patients, and they were making a lot of money."

Fitzpatrick says money from insurance companies, tax payers and women like Amanda Dikeman, who went through years of pain and suffering before the device was removed.

"My once very thick hair began falling out in clumps. I battled continuous urinary tract and kidney infections."

Lawmakers want to know why it took so long for the FDA to receive patient complaints and why nothing has been done about them.