Essure or surgery? New study compares contraceptive risks

Family planning can come with many questions, concerns and fears.Once a woman makes the personal decision to n...

Posted: Jan 23, 2018 5:14 PM
Updated: Jan 23, 2018 5:14 PM

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.

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

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 release published in September by the device's maker, Bayer.

Essure distribution has been discontinued "for commercial reasons only," according to Bayer.

Under the Affordable Care Act, many health insurance plans cover FDA-approved methods of birth control for women at no cost. In an ambulatory setting, the total cost of Essure procedures was found to be $1,287 per case and laparoscopic procedures $1,398 per case, according to a 2008 study published in the Journal of Obstetrics and Gynaecology Canada.

The new study responds to the safety issues and concerns that have been reported by women while also offering some reassurance for women who have undergone hysteroscopic sterilization without any complaints, Zureik said.

"These findings will also help both physicians and women to make a rational choice when women are deciding to undergo a sterilization," he said.

In response to the study, Bayer said in a written statement on Tuesday that it "is pleased to see more data driven evidence in support of options for women seeking permanent birth control" and that the company stands behind Essure.

Weighing sterilization options

The study looked at data on 105,357 women who underwent either a hysteroscopic or laparoscopic sterilization for the first time between January 2010 and December 2014. The procedures were conducted in 831 hospitals located throughout all 26 French regions.

The data came from the national hospital discharge database called the Programme de m-dicalisation des syst-mes d'information, and the health insurance claim database called Syst-me national d'information inter-r-gimes de l'Assurance maladie.

Since health insurance data were used, women without coverage were excluded, which was a limitation in the study. However, the researchers wrote in their study that since "this covers 75% of the French population, these findings are likely to be generalizable."

The researchers analyzed the data, taking a close look at any complications occurring at one year and three years after the sterilization procedures. Among the women in the study, 71,303 underwent hysteroscopic and 34,054 underwent laparoscopic sterilization.

Hysteroscopic sterilization was found to be associated with a significantly higher risk of sterilization failure than laparoscopic.

In the study, 4.83% of hysteroscopic patients saw sterilization failure after one year and 5.75% after three years, compared with 0.69% and 1.29% of laparoscopic patients.

"The risk of so-called 'gynecological complications' -- predominantly a need for another sterilization procedure within a year -- is well known to be higher with hysteroscopic sterilization compared to laparoscopic sterilization," according to Bayer's statement.

"Follow-up procedures are also addressed in the Essure Instructions for Use (IFU) and supported by clinical trials. Women who do not get the 3-month confirmation test are at higher risk of failure, which is why it is important for women to schedule the test to ensure that the devices have been placed properly," the statement said.

On the other hand, hysteroscopic sterilization was associated with a lower risk of surgical and medical complications during the actual procedure when compared with the more invasive laparoscopic option, the researchers found.

At the time of the procedure, in-hospital surgical complications occurred in 0.13% of the women who underwent hysteroscopic sterilization and 0.78% of those who underwent laparoscopy, the researchers found.

Medical complications occurred in just 0.06% of women who underwent hysteroscopic and 0.11% of those who underwent laparoscopy, the researchers found.

Additionally, hysteroscopic sterilization compared with laparoscopy did not significantly differ in the risks of certain medical concerns, such as autoimmune diseases, thyroid disorders or the risk of death, the researchers found.

The questions that remain about Essure

"This study provides a degree of reassurance -- but not certainty -- that there is no increased risk of medical complications from Essure compared to women getting laparascopic sterilization after 3 years; we must take that result with a grain of salt," said Dr. Sanket Dhruva, a postdoctoral research fellow at Yale University who was not involved in the study but has written about Essure.

"We still need a well-designed randomized trial that follows women for at least five years," he said. "This device has been on the US market since 2002 without that study."

As for now, there are other long-term contraception options outside of just hysteroscopic and laparoscopic sterilization methods that may be alternatives for some women, Dhruva said.

Intrauterine devices, for instance, are long-acting reversible contraceptives that can last for three to 10 years depending on the method.

Yet the new study's conclusion that hysteroscopic sterilization was significantly associated with a higher risk of gynecological complications is not as concerning as it sounds, said Dr. Rebecca Perkins, an associate professor of obstetrics and gynecology at Boston University School of Medicine, who was not involved in the study.

"We have known since hysteroscopic sterilization first became available that the procedure can be completed in a single attempt 96% of the time -- and it's the 4% rate of repeat sterilization procedures that drives the stated gynecological complication rate," she said.

"Rates of serious procedure-related complications and subsequent hysterectomies were lower in the hysteroscopic group," said Perkins, who served as first author on a separate, previous study that compared gynecologic outcomes after hysteroscopic and laparoscopic sterilization procedures.

The study, published in the journal Obstetrics & Gynecology in 2016, found that hysteroscopic sterilization may be associated with a higher rate of pregnancy, more menstrual dysfunction, more subsequent hysteroscopic procedures, less pelvic pain, and fewer intra-abdominal gynecologic surgeries than laparoscopic sterilization.

Yet pregnancy rates appeared to be similar for women who completed their post-procedure X-ray called a hysterosalpingography -- but only 66% of women did so, according to the study.

There were some other differences in findings between the new JAMA study and that previous 2016 study, Perkins said.

"We also found higher rates of abnormal uterine bleeding after hysteroscopic sterilization, and they found lower rates," she said. "I would interpret this as sterilization type having little to no effect on subsequent abnormal bleeding patterns."

'Rigorous research' needed on contraceptives

All in all, the new study is an "excellent" addition to further research that needs to be done on hysteroscopic sterilization, said Dr. Eve Espey, professor and chair of the Department of Obstetrics and Gynecology at the University of New Mexico, who co-authored an editorial that published alongside the new study in JAMA.

"This very large study is reassuring that women who undergo hysteroscopic sterilization don't have worse long-term health outcomes than women with laparoscopic sterilization. I would not say it's definitive," Espey said, adding that the clinical study the FDA approved in 2016 is still needed and underway.

"I do think it's an important piece of information to assemble together with other data to really give a fair picture of the safety and effectiveness of the device," she said. "It is very important to subject any contraceptive method or any medical technology in general to rigorous research in order to establish its safety and effectiveness."

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