NewsTue Feb 23, 2016 - 3:09 pm EST
Congressman: Essure ‘contraceptive’ caused hundreds of fetal deaths
Washington D.C., February 23, 2016 (LifeSiteNews) – A Pennsylvania congressman is calling for a controversial contraceptive device to be pulled from the market pending safety studies, saying it is behind the deaths of more than 300 unborn children.
Representative Mike Fitzpatrick said Wednesday that the Food and Drug Administration has ignored roughly 303 fetal deaths that were linked to the abortifacient sterilization device Essure.
Fitzpatrick, along with the grassroots support group for victims of Essure complications, said the FDA's own data indicates that the device's "adverse event reports" for miscarriages, ectopic pregnancies, and stillborn deaths were feasibly misreported as simple injuries or malfunctions.
"When it comes to data reporting we're talking about more than just numbers," Fitzpatrick said in a report from the local ABC affiliate. "We're talking about 300 unborn children who were killed because of the failure of a product."
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Essure is a metal coil, inserted into a woman's fallopian tubes, which intentionally irritates the tubes, creating scar tissue, which blocks the woman's eggs from being released into her womb for fertilization. It is marketed as a "permanent birth control" method, designed to induce sterility.
"Women are being harmed," Fitzpatrick said. "Citizens are being harmed."
The FDA did not adequately follow up on the device after complaints were made, Fitzpatrick said, according to NBCPhiladelphia.com, leaving massive inconsistencies in death statistics linked to Essure.
"They've been telling me that with respect to Essure, there have been five fetal deaths," Fitzpatrick said. "If you actually read the narratives of those reports that have been filed, those complains, the number exceeds 300."
The FDA approved Essure in 2002. In 2015, it expanded the list of descriptions for the device, comprising of both benefits and serious long-term health dangers, having previously listed only the benefits of Essure.
The dangers associated with the contraceptive device include ectopic pregnancies, unintended pregnancies resulting in severe complications and miscarriages, pelvic complications, pain, migration of the metal inserts through the fallopian tubes into the abdomen, puncture of the uterus, perforation of the fallopian tubes, hemorrhage, organ damage, fatigue, depression, weight gain, menstrual irregularities, headaches, rashes, itching, severe pelvic pain, and even death.
The FDA was urged last summer to reconsider Essure in the face of more than 5,000 complaints.
In an FDA hearing last October, women who had taken part in clinic trials for the Essure contraceptive device testified that reports about side-effects of the device were falsified to make the device look safer than it was, in order for the manufacturer to gain FDA approval.
The sterilization device's manufacturer, Germany-based Bayer, which bought the original Essure manufacturer Conceptus in 2013 for one billion dollars, strongly denied the women's claims.
Fitzpatrick introduced a bill in Congress last fall to ban the abortifacient device.
"The failures of Essure are well documented and wide-ranging," Fitzpatrick said at a press conference at the time, along with a group of women who had been harmed by Essure use. "Yet in the face of all these facts, this device remains on the market, certified with the FDA's stamp of approval. That's unacceptable to me and unacceptable to the tens of thousands of 'Essure sisters' who are living with this device's effects."
Fitzpatrick continued, "If the FDA or manufacturer aren't willing to act in the best interest of these women, Congress must."
The lawmaker advocated once again this week for the group of women, which has a Facebook page and has grown to more than 27,000.
"They've been ignored by their health care providers, they've been ignored by the manufacturers, and they've been ignored by the FDA," Fitzpatrick said.
One of the Essure support group's founders, Amanda Dykeman, on Wednesday shared her experiences with the device, stating, "Actually, I felt poisoned and hopeless."
"It was a horrible experience," Tamara Monroe, of Levittown, PA, said. "I had a lot of fatigue, brain fog, weight gain, very bad abdominal pain, heavy bleeding."
A recent FDA hearing on the device had several doctors speak in favor of Essure.
Bayer dismissed the claims made by Fitzpatrick and the women's Essure support group.
"It is not true that an investigation revealed 'unreported' deaths with Essure," Bayer said in a statement. "Bayer reports adverse events to FDA consistent with FDA regulations. The referenced data is also publicly-available."
Bayer said as well it is irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term. Bayer stated that ectopic pregnancies and blighted ova are not considered fetal deaths and that the data discussed on Wednesday was part of discussions during the FDA hearing last fall.
The FDA said ensuring the safety of Essure is a high priority, according to the ABC report, and a public report from the federal agency on Essure is due to be released, potentially later in February.
The FDA said as well it's received Fitzpatrick's letter and allegations and will respond directly to him.