Complications & Problematic Side Effects Linked to Essure
Even though the FDA approved Essure in 2002, complaints increased substantially in the ensuing years. In fact, we published an article recently discussing a study published by Northwestern University stating that the Essure birth control manufacturer Bayer withheld information from the FDA so that the permanent birth control implants could be approved.
Aggressive Revision Surgery & Hysterectomy
The Essure device has been linked to many different health complications in women. Some are suffering from permanent injuries and enduring aggressive surgery like hysterectomy to remove the metal birth control springs.
If you have had Essure revision surgery to remove or relocate a migrated device, we want to help you.
Dangerous Essure Side Effects & Complications
- Abdominal pain and cramps
- Unusual vaginal discharge
- Lower back pain
- Pain in arms and legs like sciatica
- Dysmenorrhea (pain during menstrual cycle)
- Recurrent UTIs
- Bacterial vaginal infection
- Painful intercourse
- Very heavy menstrual bleeding
- Spotting or bleeding between periods of menstrual cycle
- Sharp pain, burning sensation near entrance of vagina
- Amenorrhea (no menstrual period)
- Very heavy menstrual bleeding
- Abdominal spasms
- Pelvic Inflammatory Disease (PID)
- Ovarian, uterine, or fallopian cysts
- Cervical cancer
If you experience any symptoms of Essure complications, alert your doctor immediately. Some complications can get progressively worse and have permanent side effects. Your doctor may need to perform revision surgery to remove Essure from your body before more damage is done. We can help you understand your legal options and file a lawsuit if you are eligible. See if you qualify right here on our website now.
A doctor inserts the Essure (metal coil) device into each of a patient’s fallopian tubes. The inserts form scar tissue over time that inhibits the ability of sperm to reach a woman’s eggs. During the time that this natural barrier is forming, other types of birth control must be used. Essure is made from flexible materials found in other medical devices such as heart stents.
It typically takes about three months for the barrier to form in the fallopian tubes that prevents pregnancy. Once that amount of time has passed, a doctor will typically perform a test to confirm that that patient is no longer able to get pregnant. A dye is introduced to the uterus and then an x-ray is taken to see if the inserts are in place and the tubes are permanently blocked. If the die does not get past the essure implant in the fallopian tubes, then theoretically the patient cannot become pregnant by conventional means.
Yes. Essure was originally thought to be non-reversible, but there is a procedure that may allow a surgeon to remove the device by opening each fallopian tube, taking the Essure out, and then sealing the opening in each tube. In some cases the Essure removal surgery is necessary because of adverse reactions or complications endured by the patient.
There have been many reports of pregnancy in women who have had an Essure device implanted. Essure is marketed as permanent birth control via tubal ligation (aka getting tubes tied). According to a recent study however, the rate of pregnancy after Essure is about 5.7%, much more than was initially reported by the birth control manufacturer.
In some cases, such as when the uterus or fallopian tubes have been torn or perforated by the Essure implant, getting pregnant can be very difficult. Sometimes it can even be impossible. If you have sustained damage to your uterus, fallopian tubes, or any other organs because of this device, you may be entitled to compensation from the drug’s manufacturer, Bayer. Get in touch to find out how we can help.
On September 24, 2015, the FDA held a meeting of a Medical Devices Advisory Committee Panel to discuss the growing number of women who had reported health problems and injury after Essure. According to an agency statement, the purpose of the meeting was to hear opinions from scientists and clinicians – as well as patients – regarding Essure’s risks and benefits. As of now, there has been no Essure recall. However, several groups have organized petitions and movements to get Essure off the market so no other women can get hurt.
In addition, the FDA opened a public docket from July 22, 2015 to October 24, 2015 to solicit opinions from those who wanted to comment on the device. During that time, the agency received more than 2,800 comments.
The FDA is reviewing the minutes of the panel meeting as well as the public docket comments to determine its next steps. The agency announced that it expected to make those next steps public by the end of February 2016.
Some of the most disturbing, horrific Essure side effects have been widely publicized.
You may be eligible to file a lawsuit for complications after Essure if you have experienced one of the following:
- Need for Hysterectomy
- Essure Device Puncturing Surrounding Organs
- Giving Birth to Stillborn Child
- Essure Device Failure
- Essure Rejection
- Uterine Polyps
- Eptopic Pregnancy
- Potentially Fatal Internal Bleeding
- Ruptured Fallopian Tube
- Migration of Essure Coils
- Excessive, Prolonged Menstrual Bleeding
- Nausea & Vomiting
- Need for Repeat Surgery
- Large Group Experiencing Flu-like Symptoms and Hair Loss
There have been several recent news stories highlighting some of the severe health complications associated with the use of Essure. A July 14, 2015 article on the website of National Public Radio (NPR) detailed the story of an Illinois woman who said her body had been “permanently ruined inside and out” after the device was inserted.
The woman told NPR that she had experienced a wide range of symptoms soon after her Essure was inserted in 2010. These included digestive problems, fatigue, migraine headaches, abdominal pain, hair loss and many others. She later found a Facebook group that contained nearly 20,000 women who had gone through health complications after using the device.
According to the article, the Essure device has been inserted in approximately 750,000 women. Since approving Essure, the FDA has received about 5,000 reports of medical issues associated with the device. In more than 400 of them, doctors or patients reported that the coils of the Essure migrated to other areas of the reproductive system. There were five reports of fetuses dying after the device failed to prevent a pregnancy.
On October 13, 2015, The New York Times reported the results of a study of more than 50,000 women who had the Essure inserted from 2005-2013. Those women, according to the study, were 10 times more likely to need a repeat surgery within a year than women who had their fallopian tubes tied.
The Times also reported the story of a social worker who dealt with health problems for six years after having an Essure device inserted in 2008. In addition to painful menstrual bleeding that lasted anywhere from 10-15 days a month, she also had extreme fatigue and painful intercourse.
After consulting several physicians, she had a hysterectomy performed in 2015. Both the surgeon and a pathologist told her that after her uterus was removed and examined, it was found that the Essure device had migrated into the uterus and was surrounded by scar tissue.
A U.S. Congressman from Pennsylvania has become so concerned with reports of Essure device complications that he is taking action to try and take the device off the market. Mike Fitzpatrick introduced a bill called the E-Free Act, which would require the FDA to revoke premarket approval for Essure. Not only would the take Essure off the market if passed, it would also remove the shield that currently protects Bayer from litigation.
However, even if Rep. Fitzpatrick’s efforts to revoke premarket approval for Essure fall short, patients who have been harmed by the device may still be able to take legal action against Bayer. For example, if it can be proven that Bayer engaged in improper behavior when manufacturing the device, that could render its premarket approval invalid.
Why Essure Manufacturers are Negligent
Plaintiffs in lawsuits have alleged that Bayer included the use of non-conforming materials when manufacturing the Essure device, and also manufactured the product at an unlicensed facility. In addition, plaintiffs allege Bayer concealed negative reports regarding the device from the FDA.
How Baron & Budd Can Help You File an Essure Lawsuit
If you have been harmed after having an Essure device implanted for tubal ligation, Baron & Budd may be able to help. Get started online or call # to speak with a lawyer about filing an Essure lawsuit for compensation.