Mike Fitzpatrick, a Republican state rep for Pennsylvania, has become the unlikely leader of a Congressional movement to reassess the safety of medical devices marketed to women. Fitzpatrick spearheaded a legislative review of the FDA’s handling of power morcellators, a device used to grind up uterine fibroids that can also spread uterine cancers. Now he’s taking on Essure, a controversial form of permanent female sterilization that thousands of women say can cause horrific side effects.
Essure Controversy Nears Crossroads In February 2016
Fitzpatrick has even introduced a bill, the E-Free Act of 2015, named in solidarity with the “E-Sisters” Movement, a group of tens of thousands of women who have joined forces on Facebook to share their stories and organize for legislative change. The representative’s Act would compel the FDA to withdraw Essure’s approval, taking what many critics consider an intolerably dangerous device off the market. The E-Free Act has bipartisan support. Along with Fitzpatrick, the bill is co-sponsored by Republican representatives Marsha Blackburn, Christopher Smith and Lou Barletta, along with Gregorio Sablan, a Democrat representing the Northern Mariana Islands.
Fitzpatrick, though, isn’t the first Congress-person to turn a dubious eye on Essure’s safety. Noting “more than 5,000 adverse event reports filed by doctors and patients about Essure,” Rosa DeLauro, a Democratic rep for Connecticut’s 3rd District, petitioned the FDA’s Acting Commissioner to “remove the device from the market” all the way back in October of 2015.
Thousands of women have raised their voices against Essure, and some have even chosen to file lawsuits against the device’s current manufacturer, Bayer. But the controversy over this common procedure’s safety is far from over. The FDA plans on announcing the results of its review sometime in February 2016. In the meantime, the E-Sisters plan to descend on Washington, D.C. en masse, in support of Fitzpatrick’s E-Free bill.
High Cost Of High-Risk Devices Prevents Lawsuits
Many of the E-Sisters have expressed a desire to file lawsuits against Bayer, but as their Facebook page notes, any hope of legal action faces significant barriers.
As a Class III device, one believed to pose a potentially significant health risk, Essure was sent through a special FDA approval process, one more stringent than is required for less-risky devices. In fact, the process is so rigorous that device manufacturers should be shielded from product liability lawsuits, according to the US Supreme Court.
Bringing a medical device through this special approval process, known as Pre-Market Approval (PMA), is highly costly. On average, FDA reviewers spend 20 hours analyzing evidence for a 510(k) approval, the process used for less-dangerous devices. Pre-Market Approval, on the other hand, usually takes around 1,200 hours. That’s a significant expenditure, one medical device manufacturers have to pay for. In 2016, applying for 501(k) approval cost $5,228. Applying for the Pre-Market Approval of a Class III device cost $261,388.
Obviously, there’s a significant down-side to pursuing innovative new products that might turn out to be harmful: it’s expensive. Some have expressed concerns that no device manufacturers would pursue these potentially beneficial products, without a promise of protection from the liability entailed by their possible dangers.
The Supreme Court agreed, in a 2008 case called Riegel v. Medtronic. In a 9 to 1 decision, the Court held that product liability lawsuits based on state law (most commonly allegations that a drug manufacturer failed to warn patients of a device’s risks) are federally “preempted,” since the device’s approval is in accordance with strict federal oversight. When federal and state laws conflict, federal laws trump state ones.
Focused On Legal Reform, E-Sisters Head To Washington
Critics say that’s a protection no manufacturer should enjoy. In their trip to Washington, the E-Sisters plan to lobby for a change in the federal preemption laws, and want Essure’s liability protection stripped as well. The handful of Essure lawsuits currently sitting in federal courts are challenging federal preemption explicitly. A bill, introduced in 2008 by Democratic Representative for New Jersey Frank Pallone Jr., sought to remove the clause sanctioning federal preemption for PMA devices from the Federal Food, Drug, and Cosmetic Act. Despite 71 co-sponsors, Pallone’s bill died in Congress.
The FDA has been aware, at the least, of what women are saying about Essure for years. The agency only decided to begin investigating the problem, however, in September 2015, convening a meeting of its Obstetrics and Gynecology Devices Panel. Experts and practicing physicians gathered to discuss the device’s applications and risks, joined by patients who testified to their side effects, which often include extreme pain. A public docket was opened, receiving over 2,800 comments between July 22 and October 24 of that year.