When you have a medical device surgically implanted and there's a problem with it, you might consider
suing the manufacturer, just like the thousands of women who say Essure birth control has caused their
serious health issues.
But they can't sue the maker of Essure because of the way the device was approved by the FDA.
Now, members of Congress say it's time to change that.
Lawmakers said it's crazy that a company can't be held liable when its product is dangerous especially when it's a medical device that's causing serious health complications and even deaths.
And women who've used Essure birth control couldn't agree more.
“This is a very exciting day for everyone,” Tess Schulman told reporters.
She can’t believe that it's finally happening.
For years, she and other women have been trying to warn others about the dangers of Essure, a birth control device made up of coils that are implanted in a woman's fallopian tubes.
NewsChannel 5 Investigates first began reporting about problems associated with Essure three years ago.
Since then, more than 25,000 women have complained about serious side effects, including extreme pelvic and abdominal pain, migraines, and damage to their uterus and other organs.
“Every once and a while there's a medical device that will get approved through either a fast track
approval or a more rigorous approval that may do more harm than good -- and that's what we're here to
talk about,” said U.S. Rep. Mike Fitpatrick, a Republican from Pennsylvania.
Fitpatrick, speaking at a news conference Wednesday in Washington, was alarmed to hear that Essure has led to the deaths of at least four women and nearly 300 unborn children.
When the device was approved by the FDA, the federal agency gave the makers of Essure something called pre-exemption status, meaning the company cannot be sued for problems caused by the device.
Now, Fitpatrick has introduced legislation that he says will change the way medical devices are reviewed
and will give victims the right to sue.
Tess Schulman was thrilled.
“It's going to open a lot of doors we hope for women to pursue justice,” she said.
Schulman added that this will not only hold manufacturers accountable for dangerous products, but
she's hopeful it will help women who have been hurt by Essure.
“Out of the 29,800 people we have, only a fraction of us have been able to afford to have the device
removed. So with this legislation, we hope people can pursue legal avenues to help them get the device
removed because there are so many women still suffering with it,” Schulman explained.
The legislation is being called Ariel Grace's Law, named after a little girl who was stillborn after her
mother's Essure failed.
If this measure passes, it will apply not only to Essure, but all medical devices.
Right now, some 360,000 devices have that FDA protected status and their makers cannot be sued if the product is unsafe or defective.