Posted 17 February 2016
By Michael Mezher
Editor's note: After publishing this article, Focus received comments from Bayer refuting the allegations made by Rep. Fitzpatrick. See our coverage of Bayer's comments in a follow up article published Thursday.
Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the US Food and Drug Administration (FDA).
FDA has said previously that it will make an announcement on its review of Essure by the end of February.
The analysis of fetal deaths presented by Fitzpatrick in a press call was conducted by Madris Tomes, founder and CEO of Device Events, a consulting firm specializing in medical device postmarketing surveillance.
According to Tomes, there are 303 reports of fetal death tied to Essure, compared to only five cases previously reported by FDA.
Tomes said her analysis of more than 10,000 adverse events related to Essure in FDA's Manufacturer and User Facility Device Experience (MAUDE) database found that many reports marked as injuries or malfunctions also describe claims of miscarriage, abortion or fetal death, whereas the number reported by FDA is based on reports specifically marked as deaths.
Fitzpatrick said the discrepancy between FDA and Tomes' analyses is indicative of problems with the agency's postmarket surveillance systems.
"It's pretty clear that FDA either has data they're not paying attention to or they've got defective systems in place to analyze the data," Fitzpatrick said.
Fitzpatrick, who sponsored a bill calling for FDA to withdraw Bayer's premarket approval (PMA) for Essure in November, sent these claims in a letter to Jeffrey Shuren, director of the Center for Devices and Radiological Health at FDA.
The letter calls on the agency to take Tomes' analysis into account in its ongoing review of Essure's safety.
In his letter, Fitzpatrick also raises allegations stemming from a whistleblower complaint filed against Bayer and Conceptus in 2013 claiming the companies provided "illegal kickbacks [to doctors] in the form of free medical equipment valued at $20,000" to doctors to promote the device.
However, these allegations were never proven. The case, which was filed on behalf of the US, and 27 states and the District of Columbia, by a former Conceptus sales representative was dismissed without prejudice before going to trial. Because the case was dismissed without prejudice to the government, it is still possible for the government to look into these allegations in the future.
Essure's Safety Questioned
Essure was first approved in 2002 through the PMA pathway, FDA's most stringent for medical devices. The device is also CE marked and sold in the EU.
The device consists of a pair of small nickel-titanium coil wrapped in polyethylene terephthalate (PET) fibers and is placed in the fallopian tubes, prompting tissue growth into the coils, which blocks sperm from fertilizing a woman's eggs.
Upon approval, Conceptus, the device's original manufacturer, was ordered to conduct two post-approval studies (PAS) and FDA also required three additional PAS for each of three PMA supplements submitted for the device.
However, Essure Problems, a patient group founded on Facebook in 2011 by Angie Firmalino, has raised questions about Essure's safety.
The group currently has more than 27,000 members and works to raise awareness about serious side effects they say are caused by Essure, and continues to call for it to be removed from the market. Its members have also actively petitioned Fitzpatrick and other members of congress about the device, and on 3 February 2016 met privately with FDA to discuss its review of Essure.
During the call, Firmalino described her experience after receiving Essure:
"Immediately I started experiencing problems, I was having pain … heavy bleeding … running fevers … this went on for about two years, and my doctor continued to tell me, 'you know, it's just your body getting used to the device' … Finally … they decided to do an ultrasound and that's when they discovered one of my coils had expelled from the fallopian tube and was embedded in my uterus," she said.
"I felt poisoned and helpless," said Amanda Dykeman, a patient who, along with Firmalino, runs the group Advocating Safety in Healthcare E-Sisters (ASHES).
Patient outcry over the safety of the device prompted FDA to conduct a review Essure in 2013. At the time, the agency concluded that Essure was an effective alternative to surgical options such as tubal ligation.
However, in 2015, FDA launched another review of the device after continued public pressure from patients and allegations of misconduct on the part of Bayer/Conceptus.
On 24 September 2015, FDA held a public meeting of its Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to hear patient and expert testimony about Essure in order to make "recommendations regarding appropriate device use, product labeling and potential need for additional postmarket clinical studies."
The panel ultimately recommended that Essure should remain an option, especially for "women who are not good candidates for laparoscopic or general surgery," but raised concerns about the potential for allergic reactions to materials used in the device.
"How do we not have data on nickel allergies when we have a device that's 55% nickel?" said panelist Dr. Peter Schalock.
Editor's note: Bayer's comments are reproduced in full bellow.
We are aware that Congressman Mike Fitzpatrick held a press briefing on February 17th related to Essure® permanent birth control.
It is not true that an investigation revealed "unreported" deaths with Essure. Bayer reports adverse events to FDA consistent with FDA regulations. The referenced data is also publicly-available. While no method of contraception can offer 100% efficacy, Essure offers women a highly effective method of permanent birth control. Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications. It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term. In the post-market data, there is no data showing any increased risk of miscarriage and other complications compared to pregnancies in similar-age populations. Ectopic pregnancies and blighted ovum are not considered fetal deaths and can occur for a multitude of reasons not related to Essure. Moreover, the medical literature on pregnancy outcomes with Essure primarily comes from closely-monitored, desired pregnancies after Assisted Reproductive Technology1 and does not report high rates of premature membrane rupture, preterm labor or delivery, or serious complications.
The Congressman's statements repeat unfounded allegations from an unsealed legal or "qui tam" complaint. These allegations were made over a year ago and the United States Department of Justice thoroughly investigated them. After its investigation, DOJ declined to intervene and prosecute the case. The qui tam plaintiff also voluntarily dismissed the case. DOJ has closed its investigation. The matter is now fully concluded.
Bayer is also aware of quotes on the number of members of a private Facebook group. It is unreliable to cite that number of group members as if it were the number of Essure patients experiencing adverse events from the device. Without transparency, the public cannot confirm how many members of the page are Essure patients, let alone confirm the nature of their health complaints, if any.
As the federal authority responsible for assessing the continued safety and efficacy of medicines and devices, FDA held a meeting of the Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee in September to seek expert advice on the safe and appropriate use of Essure. Contrary to other reports, the post-market data disclosed and discussed at this meeting did include ectopic pregnancy and preterm pregnancy complications. There was agreement among the Panel members that Essure is an important contraceptive option and the Panel provided advice for FDA and Bayer to consider. We anticipate FDA to release a communication on that discussion by the end of this month.
Choice of contraception and the decision to use a permanent method is a very personal one that should be made between a woman, her partner and her healthcare provider. Not every option is right for every woman. This is why choice is so critical. Tubal ligation and, actually, pregnancy itself, carry risks, which can be serious.
Bayer is particularly concerned about statements that may be creating an atmosphere of unfounded fear, or that may be encouraging women who are not experiencing adverse symptoms from Essure to seek removal of Essure. The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed.
1Essure is not indicated or labeled for use in this manner. Essure is approved by the FDA for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Bayer does not promote or endorse off-label use of any of our products. We encourage healthcare providers to refer to the FDA-approved Instructions for Use (IFU) available here to guide appropriate use of the product.