April 10, 2018 (LifeSiteNews) – The U.S. Food and Drug Administration has announced new restrictions on who can offer the birth control implant Essure, along with new requirements for informed consent to the device’s medical risks.
The agency announced Monday that the permanent implant must now carry a label that restricts its sale and distribution to providers that review a brochure entitled “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” with patients beforehand. After reviewing the document, both the patient and the physician performing the implantation must sign an informed consent acknowledgment.
The pamphlet lists perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pelvic pain, suspected allergic or hypersensitivity reactions, and ectopic pregnancy as potential side effects of Essure. It adds that some women have reported headaches, fatigue, weight changes, hair loss, and mood changes such as depression, though those symptoms’ link to Essure remains unconfirmed.
It further warns that Essure’s safety and effectiveness for women below age 21 and above age 45 remain unknown, as do the safety and effectiveness of reversing the procedure.
The FDA also says that through the end of 2017, there have been 10 reported instances of adult death related to Essure, 20 instances of miscarriage, and four instances of an infant dying after a live birth. It cautions that it cannot “determine whether the device caused the death with only the information provided in the report,” but Device Events founder Madris Tomes said Essure is actually responsible for as many as 303 fetal deaths.
The FDA expects Essure manufacturer Bayer to “immediately” implement the new rules and says it will monitor its actions for compliance.
These new rules follow a February 2016 decision ordering Bayer to conduct a review of their product’s safety and add a warning to its packaging. The FDAY says that since then, American sales of Essure have declined by about 70 percent.
“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA Commissioner Scott Gottlieb said in the announcement. “We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information.”
“That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks,” Gottlieb added.
Bayer responded Monday that Essure is a “safe and effective medical device” whose benefit/risk profile “remains positive.” But CNN reported that the FDA registered more than 5,000 complaints about the implant from November 2002 to May 2015, and that 2017 saw a almost 12,000 “adverse event reports” concerning Essure. In its most recent financial statement, Bayer reported that more than 16,000 Essure users had filed lawsuits against Bayer for experiencing hysterectomies, perforations, depression, and weight gain.
In a 2016 study, researchers from Northwestern University concluded that the FDA originally approved Essure after examining only its short-term effects and left it on the market without performing adequate follow-up trials or observation. “There are much higher standards for the approval of new drugs, whether oral, injectable or even topical,” Dr. Steve Xu said. “The important question to ask is: Should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”
In 2015, several women who participated in clinical trials for Essure testified that FDA researchers altered reports to hide their severe reactions to the device.
While this week’s development comes as welcome news to many pro-lifers, others believe the government should go further. Former Rep. Mike Fitzpatrick, R-Pennsylvania, introduced legislation to ban Essure entirely in 2015.
“The failures of Essure are well documented and wide-ranging,” Fitzpatrick said at the time. “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.”