Study Raises Awareness About IUD Perforation

By Jonathan Springston, Editor, Relias Media

Scattered reports of an intrauterine device (IUD) leading to perforations and punctures of the uterus led investigators to dig deeper into the subject.

Backed by funding from Bayer (maker of the popular Mirena IUD) and a mandate from the FDA, researchers examined the medical records of about 327,000 women age 50 years or younger who underwent IUD insertion between 2001 and 2018. They found 1,008 uterine perforations attributed to IUDs that contained copper or a progesterone hormone.

Perforation risk was nearly seven times higher if the IUD was inserted between four days and six weeks postpartum. Risk increased by approximately one-third if inserted during breastfeeding. Perforation risk was lower if IUD insertion occurred more than a year after delivery, in women who had never given birth, and when implantation happened at delivery.

“Perforation remains an incredibly rare event for all clinical time points. Despite a slight increased risk of perforation with breastfeeding at IUD insertion, the benefits of breastfeeding and effective contraception generally outweigh risks and should have little clinical impact,” the authors wrote. “Therefore, IUD insertion timing should be based on individual desire for IUD contraception and patient convenience to assure an IUD insertion can occur. Careful follow-up of individuals at higher risk of uterine perforation is warranted.”

The results of this study led Bayer to revise the Mirena safety label to give better information for patients and providers.

“This study provides additional information on which patients may be at higher risk of perforation and which patients may need additional monitoring. It is a reminder to providers that the consent process is critical and that we should provide better instructions on what to watch for,” said Susan Reed, MD, an OB/GYN with the University of Washington School of Medicine. “The main takeaway is that follow-up may be warranted with these specific groups of patients. We want to stress to women that this is a safe option for contraception.”

For more on this and related subjects, be sure to read the latest issues of Contraceptive Technology Update and OB/GYN Clinical Alert.