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Regulatory News | 22 February 2016 | By Michael Mezher
Editor's note: Last week Focus reported on allegations made by Rep. Mike Fitzpatrick (R-PA) about the permanent birth control device Essure. During the call, Fitzpatrick claimed that Essure was associated with 303 reports of fetal deaths and raised allegations that Conceptus, Essure's original manufacturer, provided illegal kickbacks to doctors to promote use of the device.
Please see our previous coverage of the allegations and follow up discussion of those allegations along with Bayer's response.
This article covers a clarification from Rep. Fitzpatrick's office and Madris Tomes, a consultant whose analysis of publicly available data from the US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database sparked the allegation that Essure was associated with more cases of fetal death than previously reported by FDA.
Following the press call and subsequent coverage of the claims raised by Rep. Fitzpatrick, Aaron Clark, Fitzpatrick's press secretary, told Focus that the claims made during the call were intended to "ensure [FDA is] reviewing all the data and analysis that's out there" for Essure.
Tomes echoed this sentiment in an interview with Focus over the weekend, saying her "goal is to make sure that the FDA has seen this data."
FDA is in the process of reviewing available data for Essure and is expected to make an announcement on its review this month.
When discussing device safety monitoring, Tomes said, "Adverse event data has to be taken into consideration with other sources … outcomes data, scientific studies, etc. There are various initiatives at the FDA that have a lot of merit (Sentinel, MDEpiNet). UDI [unique device identifier] is rolling out and the goal is certainly to track devices (implanted, re-usable especially) more accurately in the future. This relies on its use in [electronic health records] EHRs, potentially in claims systems, and in adverse events to truly get a look at the broader picture. Currently, the UDI, when reported on an adverse event report, is being redacted in Public MAUDE. This limits the ability for transparency. With that being said, if [FDA] works toward transparency and in concert with other agencies (CMS involvement required for UDI in claims, for instance), forward strides will definitely be made."
"When UDI is fully implemented and included in Sentinel, it will be a powerful tool. Keep in mind, though, that many issues identified with adverse event reports are malfunctions that may not have affected a patient or resulted in a claim or outcome. Sentinel is not a replacement for the adverse event reporting system. Data in these malfunction reports is critical to identify product deficiencies (ex. scope cleaning issues, bacterial contamination of devices) and shouldn't be discounted. The UDI has significant potential, but still relies on implementation and the FDA is working hard toward that," she said.
Tomes also said she originally became interested in analyzing adverse events for Essure after seeing tweets about nickel used in the device made in response to an FDA panel on 24 September 2015. Out of curiosity, Tomes used her system to search adverse event reports for Essure mentioning nickel.
"There were 544 reports," she said.
In an email response to Focus, Clark pointed to statements made by Diana Zukerman, president of the National Center for Health Research, appearing in Qmed last week:
"One of the questions would be whether ectopic pregnancies were counted as fetal deaths. That's important because ectopic pregnancies are probably caused by Essure and always result in fetal death. If FDA had decided to count ectopic pregnancies separately from fetal deaths, they should have clarified that."
"If all doctors reported complications and fetal deaths, that would be important information for patients to have. But in the real world, a lot of doctors wouldn't report those things," Zuckerman says. "They might not report pelvic pain either, because the doctors were told by the company that pelvic pain was unrelated to the device. But if you have a device in the pelvic area and you have pain there, there is a good chance they were related."
During the press call, Fitzpatrick raised allegations stemming from a complaint filed by a former Conceptus employee in the US District Court for the Northern District of California in 2013.
The complaint alleged that Conceptus, which was bought by Bayer the same year, gave illegal kickbacks to doctors to encourage use of the Essure device.
However, the complaint was voluntarily dismissed before going to trial, and the allegations raised were never proven. Bayer has adamantly denied these allegations, stating "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."
When asked whether Fitzpatrick's office stands by those allegations, Clark told Focus that "the Congressman was seeking to ensure the FDA was aware of the filing and asking for it to be included as part of the agency's review."
Clark also said that Fitzpatrick "had heard many of the same things from Essure victims" and provided a letter written by Dr. Charles Monteith, a fertility surgeon and former medical director for Planned Parenthood of Central North Carolina, that claims Conceptus "arranged for physicians to obtain the surgical equipment for Essure insertion at no cost if two Essure kits were purchased each month."
Additionally, Clark emphasized that the issues raised are significant to "the manufacturer's insulation from any civil liability … based on the Supreme Court ruling in Riegel v. Medtronic," which established that FDA's premarket approval of a device preempts liability claims by individuals.
Tags: Essure, Rep. Mike Fitzpatrick (R-PA), MAUDE