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Regulatory News | 18 February 2016 | By Michael Mezher
Editor's Note: On Wednesday, Focus reported allegations raised by Rep. Mike Fitzpatrick (R-PA) during a press call that Bayer's permanent birth control device Essure is associated with far more reports of fetal death than previously reported by the US Food and Drug Administration (FDA). After publication we received a statement from Bayer Healthcare refuting those allegations. In this article we discuss Bayer's response and clarify certain aspects of the claims made by Rep. Fitzpatrick and Madris Tomes, a consultant who investigated the claims.
During the call, and in a letter addressed to Jeffrey Shuren, director of the Centers for Devices and Radiological Health (CDRH) at FDA, Fitzpatrick asserted that data from the Manufacturer and User Facility Device Experience (MAUDE) database shows more than 300 reports of fetal deaths, compared to five cases of fetal deaths previously reported by FDA.
Other media outlets reported on the claims as well:
Retuers: FDA likely underestimated fetal deaths from Essure: analyst
Modern Healthcare: FDA grossly underestimated harm from permanent contraceptive Essure, lawmaker says
Focus received an email from Tara DiFulmeri, representing Bayer Healthcare's women's healthcare communications team, refuting the claims made by Fitzpatrick Wednesday:
"It is not true that an investigation revealed 'unreported' deaths with Essure. Bayer reports adverse events to FDA consistent with FDA regulations ... 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."
After closer inspection by Focus of the data, presented by Fitzpatrick and Tomes Wednesday, only 16 case reports mention the term "fetal death," two of which are marked as duplicates. Several others use the term "stillborn," and the vast majority of reports cited by Fitzpatrick and Tomes indicate an ectopic pregnancy or miscarriage.
The distinctions between these terms are significant as they describe different events and would not all be counted as "fetal death," according to FDA's patient problem code hierarchy:
Death, Intrauterine Fetal C50620; FDA 1855 - Death in utero; failure of the product of conception to show evidence of respiration, heart beat, or definite movement of a voluntary muscle after expulsion from the uterus, with no possibility of resuscitation.
Miscarriage C34336; FDA 1962 - Loss of the products of conception from the uterus before the fetus is viable; spontaneous abortion.
Pregnancy, Ectopic C34945; FDA 1819 - The state or condition of having a developing embryo or fetus in the body (outside the uterus), after union of an ovum and spermatozoon, during the period from conception to birth.
However, Amanda Dykeman, a patient advocate and member of the Essure Problems group, told Focus that the issue isn't how these events are labeled, but that for these women, Essure is "failing to begin with. That's a major problem." She also cited the CDC website which defines fetal death as "the spontaneous intrauterine death of a fetus at any time during pregnancy."
While Fitzpatrick and the patient group Essure Problems have called on FDA to revoke Essure's premarket approval (PMA) in response to reports of serious side effects associated with the device, FDA has thus far supported the device's authorization.
In addition to FDA's initial approval of Essure in 2002, FDA has ordered additional post-authorization studies (PAS) for the device, and in 2013 again concluded that the device is an effective alternative to surgical options such as tubal ligation.
In its statement, Bayer defended Essure's safey and efficacy, stating the device "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."
However, a recent study appearing in The BMJ found that women who underwent hysteroscopic sterilization with Essure were more likely to undergo reoperation compared to women who had tubal ligation.
FDA is currently in the midst of another review of Essure following the panel meeting and is expected to make an announcement on its findings by the end of February.
When asked about the review, FDA spokesperson Deborah Kotz told Focus:
"Ensuring the safety of Essure is a high priority issue for the Agency. To date, the FDA has been examining all available sources of information, including the latest studies, expert input and patients' testimony from our panel meeting, and medical device reports to better understand long-term complications. We are working expeditiously to conduct an evidence-based review of all available information to inform what future actions may be in the best interest of women using or considering Essure."
Kotz also said the agency has received Fitzpatrick's letter and is working to respond. Focus contacted Fitzpatrick's office for further comment but has not received a reply.
Fitzpatrick also raised serious allegations against Bayer and Conceptus, the original manufacturer of Essure that Bayer acquired in 2013, stemming from a complaint filed by a former Conceptus employee in the US District Court for the Northern District of California in 2013.
During the call, and in the letter to Shuren, Fitzpatrick failed to mention that the allegations were never proven and that the complaint was dismissed before going to trial.
In response, Bayer stated:
"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 [DOJ] 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."
Focus was unable to verify Bayer's claim that DOJ conducted an investigation, but DOJ spokeswoman Nicole Navas was able to confirm that "the whistleblower voluntarily dismissed the case prior to the United States making a decision regarding intervention, and the case is now closed. We decline to provide further comment as to why the case was dismissed [and] do not confirm or deny the existence of an investigation."
When asked about the claim that DOJ "thoroughly investigated" the allegations, DiFulmeri told us: "the DOJ conducted an investigation that lasted a year and a half, so Bayer stands behind the statement that a thorough investigation was done."
Tags: Essure, Essure Problems, Bayer