A new study casts more doubt on the safety and effectiveness of Essure, a nonsurgical female sterilization method that has resulted in thousands of adverse event reports.
Women using Essure were more than 10 times more likely to have complications that required corrective surgery within one year when compared with women who underwent another sterilization option called tubal ligation, found a study published Tuesday in BMJ, a journal of the British Medical Association.
Critics recently asked the Food and Drug Administration to limit Essure's use as concerns about the device have mounted in recent years.
Essure is a “serious safety concern” with major public health and economic implications, the authors said. With as many as 600,000 Essure sterilization procedures performed annually in the United States, that means more than 10,000 women needed an extra surgery over the past five years, estimated researchers from Weill Cornell Medicine in New York.
The need of re-operation remained high over years. The women with Essure were eight times more likely to undergo a secondary surgery at two years, and six times more likely at three years.
Bayer continues to support the device, saying the benefits outweigh the risks. Over a decade of research, development and real-world experience supports the method, the manufacturer said in a statement.
The device is a small, soft, flexible coil made out of nickel that is inserted into each fallopian tube. Scar tissue forms around the coils, blocking the tubes and preventing eggs from becoming fertilized or getting into the uterus. It uses no hormones and requires no surgery or anesthesia to insert. The procedure can be done in an OB-GYN's office in less than an hour.
However, women who have become pregnant or experienced serious problems—such as persistent pain or having the device shift out of position—have been taking complaints to social media and activists like Erin Brockovich. Those complaints caught the attention of the federal government.
The FDA in June said its adverse events database had logged more than 5,000 reports from patients and from clinicians who implanted the device. During a September hearing Bayer revealed it had received more than 17,000 complaints globally. A panel of independent experts argued not enough research was done to prove safety before the device was approved.
Authors of the the new BMJ study shared that sentiment. The observational study compared 8,048 women in New York state who got Essure between 2005 and 2013, to 44,278 who had tubal ligation during the same period.
Not only were the the chances of needing a secondary operation higher among women with Essure, the total cost for inserting the device was about $2,700 higher than tubal ligation. Still, the study found the risk of unintended pregnancy was low for both types of procedures.
The manufacturer argues that unmeasured factors may have influenced the relationship between use of Essure and the need for re-operation, a term that Bayer says the researchers use ambiguously. However, they also say the study further supports the established high efficacy rate of the hysteroscopic procedure.
Others contend, however, that the mounting concern with the device highlights major problems in the U.S. device approval process.
Dr. Art Sedrakyan, a professor of healthcare policy at Weill Cornell and lead author of the BMJ study, pointed to issues with accessing data, lack of investment in registries to track real-world performance and industry hesitancy toward implementing unique device identifiers to track outcomes.
“The status quo is unacceptable,” Sedrakyan said in an e-mail. “We need major investment in national data sources through policymaking. Current major funders don't seem interested in making these investments.”
