Essure Procedure Problems Include Reports of Fetal Deaths, Miscarriages: Congressman

A U.S. lawmaker says the FDA has greatly underestimated the number of fetal deaths, miscarriages and other problems from Essure procedures, raising further concerns about the safety of the controversial sterilization implant.

Essure is a permanent form of birth control offered as an outpatient procedure, where the doctor inserts bendable coils into the fallopian tubes. This process causes scar tissue to form around the coils over several months, which is supposed to block the tubes and prevent pregnancy.

Over the past few years, there have been mounting concerns about the safety of Essure procedures, with thousands of women submitting adverse event reports to the FDA involving painful and debilitating complications where the device migrated out of position, perforated the fallopian tubes, caused allergic reactions or other problems.

During a press call this week, Representative Mike Fitzpatrick, of Pennsylvania, reported that a consulting firm has identified at least 303 reports of fetal deaths linked to the Essure procedure, compared to only five that the FDA had previously reported. The analysis was done by Device Events, a medical device postmarketing surveillance consulting firm.

Between the date the birth control product was approved in November 2002 and May 31, 2015, the FDA has confirmed that at least 5,093 adverse events have been submitted involving Essure complications.

Fitzpatrick has spoken out numerous times regarding the Essure procedure, and in November introduced the E-Free Act, which would remove the Bayer birth control device’s FDA approval.

While most of the focus has been on infections, allergic reactions and internal injuries experienced by women, Fitzpatrick and Device Events CEO Madris Tomes indicate that the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database revealed hundreds of claims involving miscarriage, spontaneous abortion and fetal death that were reported to the agency and Bayer. Fitzpatrick said the findings point out flaws in how the FDA analyzes the data it has in its possession.

Fitzpatrick sent a letter to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, calling on him to address Device Events findings in its analysis of Essure safety concerns.

“In light of this immense discrepancy, I request that the FDA conduct a thorough review of this document and all of the adverse event reports received by those harmed by Essure as part of FDA’s on-going review of this medical device,” Fitzpatrick wrote in the letter.

The FDA is currently reviewing the safety of the device and has said it expects to issue a decision about the Essure procedure sometime this month.

In September, an FDA advisory committee suggested that better safety data is needed, including a patient registry and a new clinical study on safety and effectiveness. The group of independent experts also said Bayer should provide women with more detailed information about the risks of Essure procedures before the coils are implanted, suggesting that women have review a checklist of possible complications and sign off on it before getting the procedure.

A growing number of Essure procedure lawsuits are now being filed by women nationwide, alleging that the sterilization device is defective and that Bayer failed to adequately warn women of the risks of ectopic pregnancy, migration, organ perforation and infections.