Some women suffering complications from Essure Permanent Birth Control may have to have the device removed. There are several removal options to choose from. Some involve simple outpatient procedures and others may require more extensive surgery, depending on the device’s location.
If you had Essure Permanent Birth Control System inserted and you're suffering from complications, you may be entitled to compensation.
The Essure Permanent Birth Control System sold by Bayer is meant to be a permanent, non-hormonal method of birth control for women. Doctors insert two metal and fiber micro-coil inserts into each fallopian tube. After about three months, scar tissue develops around the inserts and blocks the fallopian tubes, preventing pregnancy.
While the coils are meant to be permanent, skilled surgeons developed techniques to remove the coils. Some women may choose to have the devices removed because they want another child. In these cases, doctors do what they can to reconnect and repair blocked fallopian tubes.
Not all women who wish to have Essure reversed or removed do so to grow their families. Some want the device removed because of painful side effects, said Dr. E. Scott Sills, an IVF and fertility expert at the Center for Advanced Genetics in California.
“I’ve had patients that have brought me their medical charts. They had 25 doctor’s visits in the year following Essure implantation for pelvic pain, painful intercourse and painful bowel movements,” Sills told Drugwatch. “These were healthy women who only went to the doctor maybe once a year. They don’t want to get pregnant, they just want their life back.”
Thousands of women in the U.S. and all over the world have come forward to shed light on the serious side effects that come with Essure, including infections, severe pelvic pain and bleeding, painful intercourse and even the deaths of unborn children. Desperate for relief, these women simply want Essure removed.
Doctors who specialize in fertility or pelvic surgery are usually the most qualified to diagnose Essure problems and remove the coils. Women have unique and varied reactions to Essure. But there are some common complaints doctors see in women who come to them for help.
“Typically, women will come see me with complaints of pelvic pain, heavy periods and painful sex,” Dr. Christopher Walker of UroGyn Specialists of Florida told Drugwatch. “Based upon the patient’s history of having Essure implanted and an examination in the office, we determine that it is the device causing problems.”
Walker noticed a surge in the number of women coming to him to have the coils removed from 2015 to 2016. He was happy to report that the women who came to him for help felt relief after Essure removal. After a simple outpatient procedure at his office, women can expect to recover in about two weeks, Walker said.
There are a few different approaches to removing or reversing Essure, depending on the doctor performing the procedure. Most doctors report women find immediate relief from symptoms after removing the coils.
Women who wish to remove Essure have a few options. Each surgeon has their preferred method of removal. Surgery can range from a simple outpatient procedure to extensive surgery, depending on the condition and position of the device in the woman’s body or doctor’s recommendations. Sometimes, women may need to have more than one surgery.
Essure is made up of a blend of nickel and stainless steel. It also contains polyethylene terephthalate (PET) fibers — small plastic fibers that cause scarring and allow Essure to block fallopian tubes. When Essure is removed, there is a chance that a small piece of metal or fiber will remain in the body and continue to cause inflammation and complications. Microscopic PET fibers are impossible to detect.
When opting to remove Essure, women should get several opinions and discuss all options with doctors to choose the procedure that is best for their situation. Because removing the coils is a complex procedure, only the most experienced surgeons should attempt to remove the coils.
Generally, it is easier to remove Essure before excessive scar tissue forms around the device, usually within 3 months. Surgeons will use X-rays, ultrasounds or scopes to locate the device in the fallopian tube.
Once the device embeds in scar tissue, it is more challenging to remove. Doctors who have more experience removing the device will likely get better outcomes for their patients.
A salpingotomy is a technique where surgeons cut a small hole in the fallopian tube in order to remove the Essure coils. Surgeons leave the tubes intact. This is not to be confused with salpingectomy, which is total removal of fallopian tubes.
In Bayer’s Essure package insert, the company recommends using salpingotomy to remove the device. The insert instructs physicians to make a small cut in the tube, about 2 cm in length, directly above the device and remove the device through this opening.
In order to reach the fallopian tubes, surgeons enter the body through the abdomen using laparoscopic surgery — a minimally invasive technique performed with very tiny incisions in the abdomen.
While this technique is feasible, some doctors caution against salpingotomy because few surgeons have extensive experience with making incisions in fallopian tubes. If surgeons pull too hard on the device to remove it, it can fracture, leaving small fragments in the tubes.
Women who choose to have Essure removed may end up undergoing hysterectomy, according to Dr. E. Scott Sills, a fertility and Essure removal specialist.
“Hysterectomy has been something that a lot of primary care gynecologists have been advocating as the answer to Essure symptoms.”
During hysterectomy, surgeons remove the uterus, fallopian tubes and cervix. Some surgeons maintain that this minimizes the risk of leaving fragments in the body.
Surgeons can choose to perform hysterectomies laparoscopically through the abdomen or through the vagina. Many surgeons use robotic surgery because these machines can help them make more precise cuts. Others choose a more traditional approach to laparoscopic surgery without a robot.
Laparoscopic surgeries are minimally invasive and allow for quicker healing times and less blood loss.
Some surgeons choose to use a power morcellator when performing a hysterectomy to chop up the uterus and vacuum it out of the abdominal cavity. While power morcellation requires less cutting and theoretically allows a woman to recover from the surgery faster, it may also spread undiagnosed uterine cancer in the body. In addition, some women have reported that their doctor morcellated the uterus with coils still in the fallopian tubes, spraying bits of metal and plastic fibers into the abdomen.
Hysterectomies may also cause additional health problems in the future. For example, pelvic organ prolapse and incontinence are both issues that can occur after hysterectomy. Without the uterus to provide a barrier for organs, they may sink into the vagina.
To treat prolapse a number of surgeons recommend using transvaginal mesh — another device that can cause problems such as pelvic pain, infections, and several other severe complications.
Many women who want or need Essure removed prefer to keep their uterus, because it causes fewer complications and allows them to conceive a child naturally if they choose to do so. In these cases, surgeons can perform a tubal anastomosis to carefully dissect the fallopian tubes, remove Essure and reconnect the tubes to the uterus. This allows women to reverse sterilization and conceive naturally.
In some cases, doctors can perform Essure removal on a simple, outpatient basis if the coils are properly positioned within the tube. A portion of the coil projects into the uterus and surgeons use this piece to gently pull the device from the tubes.
“My approach to patients who have had problems with Essure is to help them get rid of the problematic item — which is the Essure device itself — while conserving the healthy tissues,” said Sills, who specializes in uterine preserving surgery. “So that means that there’s a minimally invasive approach that takes maybe an hour and a half or 2 hours. It’s done like a bellybutton surgery. There’s a Band-Aid on the tummy and 2 other incisions. The incision points are about as big around as a pencil. Patients are typically home by lunch time.”
Tubocornual implantation is another uterine preserving surgical technique used by some surgeons to reverse Essure. After cutting the fallopian tube, the surgeon pulls the tube into a hole cut into the back of the uterus and reattaches it.
This can be a risky surgical technique for women who try to have another baby. Because of the hole cut into the uterus, it becomes weak and increases the risk of rupture during labor. The rupture can be fatal to mother and her baby.
Depending on the technique used to remove Essure and how long the device was in the body, women can expect to have varied recovery times.
More extensive surgery such as a hysterectomy will require a longer recovery time that may last weeks. Women who have a simple outpatient procedure to remove the device can expect to feel relief from symptoms within days.
In some cases, there are women who continue to have symptoms, like Angie Firmalino. A doctor was able to remove the coils, but after the surgery, her health issues returned. An X-ray found foreign bodies scattered in her abdomen.
But Drs. Sills and Walker have had high levels of success with their Essure removals.
“Once the foreign body is removed, women may expect to recover within two weeks,” Walker told Drugwatch.
Please seek the advice of a medical professional before making health care decisions.
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