Essure sterilization method under fire_00003911.jpg
2015: Essure sterilization method under fire
01:54 - Source: CNN

Story highlights

Hysteroscopic sterilization tied to higher risk of some complications, but not increased medical risks

"This study provides a degree of reassurance -- but not certainty," one expert says

CNN  — 

Family planning can come with many questions, concerns and fears.

Once a woman makes the personal decision to not or no longer have children, there are various types of birth control to consider and she may turn to more permanent options, such as hysteroscopic or laparoscopic sterilization.

Yet those sterilization options are not without risk.

Hysteroscopic sterilization involves placing a small implanted birth control device, called Essure, through the vagina into a woman’s fallopian tubes in order to prevent pregnancy. In contrast, laparoscopic sterilization involves making a surgical incision in or near the navel to reach the fallopian tubes and close them off with bands or clips.

A new study, published in the journal JAMA on Tuesday, compares the risks of both and suggests that hysteroscopic sterilization was significantly associated with a higher risk of gynecological complications – such as failure to work and requiring a subsequent second sterilization – but there were no increased medical risks.

The study comes on the heels of lawsuits in the United States and reports to the Food and Drug Administration about serious complications linked to the Essure device.

The controversy around tube tying

“The novelty of our study lies in the fact that we did not find differences in several medical outcomes between both approaches,” said Dr. Mahmoud Zureik, a scientific adviser with the French National Agency for Medicines and Health Products Safety in Saint-Denis, France, and senior author of the study.

“Hysteroscopic sterilization was associated with lower procedural complications and increased gynecological complications compared with laparoscopic sterilization,” he said. “Based on these findings, we cannot conclude that one procedure is safer and more effective than another. Instead, the choice between these approaches depends on factors related to both physicians, their level of experience in these methods and women’s choices.”

One of the authors of the new study disclosed receiving personal fees from Boston Scientific, a manufacturer of medical devices, including a hysteroscopic tissue removal system.

The study was conducted in France where concerns related to hysteroscopic sterilization also have been circulating and which has the second largest number of women using this sterilization method after the US, the researchers noted in their study.

Around 1 million women worldwide have undergone the hysteroscopic sterilization procedure, according to the new study.

In the US, nearly one in three women aged 35 to 44 used a sterilization method between 2011 and 2013, according to the Centers for Disease Control and Prevention.

In 2015, more than 5,000 women in the US reported to the FDA several problems related to Essure, including unintended pregnancies, stillbirths, debilitating pain, bleeding and perforation of their fallopian tubes, among other complications.

The following year, the FDA approved a new “black box warning” label for Essure. A black box warning in the labeling of products is “designed to call attention to serious or life-threatening risks,” according to the FDA.

The FDA also approved an ongoing clinical study plan to further evaluate the benefits and risks of Essure. Essure is still sold in the United States but discontinued in all other countries, including France, according to a news releas