FDA Fails to Protect Patients from PREVENTABLE Bayer Essure Harm.

Women harmed by sterilization coils push FDA to act

Updated: JUNE 6, 2017 — 7:38 PM EDT

by Marie McCullough, Staff Writer mmccullough@phillynews.com

The ranks of women harmed by Essure sterilization coils continue to grow, while the U.S. Food and Drug Administration’s efforts to inform them of the risks are not working, a 37,000-member advocacy group declared Tuesday.

Administrators of the six-year-old Facebook group Essure Problems said that in the first quarter of this year, the FDA received about 2,000 reports of women who underwent operations — usually hysterectomies — to remove coils that were causing complications such as pain and bleeding.

More than 9,000 removals have been reported since 2009, in addition to miscarriages, fetal deaths, and other problems, according to an analysis of the FDA’s “adverse events” reporting system. It was conducted by Madris Tomes, a former FDA manager who is the founding CEO of Device Events, based in York, Pa.

Angie Marie Firmalino, 44, a co-founder of the Essure Problem group on Facebook

“More than 15,500 adverse-event reports have been filed,” said Essure Problems cofounder Angie Marie Firmalino, 44, of Tannersville, N.Y., who needed a hysterectomy to get rid of fragments of broken coils. “We feel like the FDA needs to step in and take action. How much harm is acceptable for a non-lifesaving device?”

Asked for comment, the FDA said it “continues to review the available information about Essure, including reports of problems submitted to the FDA.”

The manufacturer, Bayer Healthcare, emailed: “We take all adverse events seriously. … We have reached out to many women who have reported complications … and provided any guidance we can. There are risks with all medical procedures.”

Surgeries to Remove Essure

This analysis of data from the FDA’s voluntary adverse events reporting system shows how many women needed surgery — either hysterectomy or fallopian tube removal — to remove the Essure sterilization coils because of severe problems such as pain and bleeding. Reports have been steadily increasing with growing awareness of the dangers.

Essure Problems has been among those pushing the FDA since 2013 to take Essure off the market. The coils, approved 15 years ago, are implanted in the fallopian tubes to scar them shut. The device is marketed as a simple, nonsurgical alternative to conventional tubal surgery.

Last year, the FDA ordered Bayer to add label warnings that Essure can cause chronic pain, organ perforation, and allergic reactions, and to create a “patient decision checklist.”

But about 200 women have contacted Essure Problems over the last six months to say that doctors did not tell them about the label warnings or use the three-page checklist.

“Unfortunately for many women, they are being implanted without informed consent,” administrators of the Facebook group emailed the FDA on Monday, demanding tougher action.

The FDA’s response, shared by the group: “We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration.”

Bayer, which acquired Essure in 2013, has been hit by thousands of lawsuits over the coils. Last year, the German-based company’s annual report said it incurred losses of $413 million in connection with the devices.

Bayer has said it does not know how many women have implants, just that about a million Essure “kits” had been sold worldwide, most in the U.S. The company recently announced it would discontinue sales in two small markets, Finland and the Netherlands.

Please Support Ariel Grace's Law HR5403

June 10, 2016

The Honorable __________________

___________________ HOB

Washington, DC 20515

Dear ________________________, 

H.R.5403 Ariel Grace’s Law  https://www.govtrack.us/congress/bills/114/hr5403

On June 8, 2016, Congressman Mike Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) introduced an important new bi-partisan bill.  This bill seeks to remove the preemption protection granted to Class III medical devices which receive initial premarket approval by the FDA.  Accordingly, manufacturers of medical devices, which  later may be shown to be defective and dangerous, will not be automatically shielded from liability.  Often the threat of civil litigation is the necessary force to ensure that manufacturers provide medical devices that are both effective and more importantly, safe. A similar bill had over 100 cosponsors several years ago, and we hope to drive similar bipartisan support.

The bill is aptly named, Ariel Grace’s Law, after Ariel Grace Burrell, whose stillborn birth was caused by a Class III medical device. Kristiana Burrell has given her blessing to have the bill named after her daughter and the bill was introduced on the one year anniversary of the birth/death.

This  bill is  applicable to all Class III medical devices. It is an amendment to an already existing statute and merely amends the statute to allow access to courts for those injured by defective medical devices and is states as follows:              

This Act may be cited as the “Ariel Grace’s Law

(a)  Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360k) is amended by adding at the end the following:

(b)  NO EFFECT ON LIABILITY UNDER STATE LAW- Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the laws of any State.”

(c)  EFFECTIVE DATE; APPLICABILITY. - The amendment made by subsection (a) shall

(1) Take effect as if included in the enactments of the Medical Device Amendments of 1976 (Public Law 94-295): and

(2) Apply to any civil action pending or filed on or after the date of the Act.

As your constituent, I strongly urge your support of this bill. It is unconscionable and unjust that manufacturers who have a medical device approved by the FDA pursuant to a  premarket approval process can be forever shielded from liability and immune from suit even when the device later proves to be dangerous and/or defective and causes injury to device users. It was never the intent of the Federal Food, Drug and Cosmetics Act to provide blanket immunity for medical device manufacturers for defective devices placed into the stream of commerce.  Quite simply, there is no plausible reason nor rationale for the failure to support this amendment, which serves to protect your constituents.  Accordingly, I strongly urge you to join forces with Representatives  Fitzpatrick and Slaughter and make this bill into law as soon as possible.

My best,