Consumer Drug Safety

More Women and Doctors Bringing Up Complaints Regarding Essure

Over the past several months, more and more women, along with their physicians have been bringing up complaints to the FDA regarding issues they’ve been having with the birth control implant called Essure. They are saying that the implants are causing a number of problems including bloating and pain. They also say that the implants are migrating to other parts of their body.


The FDA, according to a report from Portland, Oregon’s news station KATU, has already received well over 2,000 complaints about problems with Essure, and this number continues to grow. Interestingly, it is only recently that the number of complaints has gone up so drastically. Essure had only 850 complaints between 2004 and October of 2013. It was when the company Bayer added updates to the product label that the complaints began. The updates to the label mentioned possible complications regarding migration of the device as well as abdominal pain.

Women who have been using the device know more of the effects that it can cause, and it is giving them a better indicator as to what it is that has been causing their health issues.

The History of Essure

The FDA actually first approved Essure in 2002, and at that time, it was manufactured by, as well as created by, a company called Conceptus. Recently, Bayer, one of the biggest names in the pharmaceutical business, bought it. According to information from Conceptus, more than 750,000 women have undergone the surgery and have had the implant.

It is a relatively simple procedure, and many medical centers and clinics offer it as an outpatient procedure. The surgery is very simple and takes only a short time. The doctor will insert the device into the woman’s fallopian tubes. To do this, the doctor goes through the vagina, cervix, and uterus. This causes the formation of scar tissue, which will in turn prevent insemination and pregnancy by blocking the tubes.

The Rising Tide of Complaints

As mentioned, the number of complaints revolving around Essure is increasing rapidly, and there has been quite a bit of attention regarding the possibility of side effects associated with the implant. In fact, there was even a report of one death associated with the use of the device. The rise in complaints falls in line with the investigation that the FDA has done regarding Essure. They discovered that the complications associated with the device were actually known during the clinical trials. This includes the two biggest complaints – pain and migration of the device. However, the FDA does note that some of the other side effects people are now experiencing, namely weight gain, fatigue, and depression, were not present during the trials of the device.

The FDA concluded that there were more benefits than risks associated with the device, and they allowed it to stay on the market. However, they’ve said that because of the complaints and issues, they are going to be monitoring the complaints that they receive regarding Essure.

The Biggest Complaints

Pain in the abdomen is the biggest complaint the FDA is seeing, and the device migrating out of the fallopian tubes is causing another problem, namely pregnancies. Some women who are using the birth control device are actually getting pregnant.

Many experts feel that the number of issues with the device is actually much higher, but women are not reporting the issues. They feel that perhaps only about ten percent of the issues are actually getting reported, which means that many women out there might be suffering right now and not realize why. Those women who feel as though they may have issues relating to Essure should speak with their physician right away. They may also want to speak with an attorney about what they should do next.

Show Sources
  1. KATU