Essure Problems | Unglesby Williams | Essure Lawyers
ESSURE PROBLEMS – ESSURE ATTORNEYS
ESSURE PROBLEMS: “Essure sterilization implants are commonly presented to women seeking permanent birth control as an easier, supposedly non-surgical alternative to getting their tubes tied.” Bayer, the manufacturer of Essure, promises a lifelong contraception through a, non-surgical, quick outpatient procedure. This appealed to many patients, as about 750,000 women worldwide have chosen to recieve the implant as an alternative to other methods of birth control.
However, thousands of American patients and physicians are reporting that Essure has made their lives a nightmare, reporting an extremely long list of severe side effects. Moreover, these side effects are leading to a host of health complications. Essure has now been linked to over 100 side effects.
ESSURE SIDE EFFECTS – ESSURE LAWSUIT
MedWatch, the FDA’s reporting system, shows more than 10,000 complaints have been filed by patients and doctors. As well as MedWatch, multiple women, doctors, and government officials have taken to the media and social media to voice their complaints and concerns. Social Media pages like “Essure Problems” have emerged to provide one option for victim support. Per reports, some of the most frequently-reported side effects for Essure include, but are not limited to:
- Heavy Menstrual Bleeding, Abnormal Bleeding & Elongated Periods
- Pregnancy & Fetal Death
- Pelvic Pain
- Metal Allergies & Reactions
- Headaches & Migraines
- Extreme Weight Gain & Weight Loss
- Painful Sexual Intercourse & Loss of Sex Drive
- Depression, Mood Swings & Suicidal Thoughts
- Device Migration & Internal Ovarian Perforation
- Back Pain & General Soreness
- Hair Loss, Finger Nail Loss & Tooth Loss
- Vaginal Discharge & Infection
You can find more about side effects and victim experiences on our website.
Essure Complications – More than Just Side Effects – Essure Lawsuit – Essure Lawyers
Some of reported complications linked to women with the Essure Birth Control device:
Unplanned Pregnancy. Although Bayer consistently reports a 99% effective rate, the reports show otherwise. “A 2014 study conducted by Yale and UC Davis found that Essure users were more than 3 times more likely to get pregnant than women who were sterilized via tubal ligation, with a pregnancy incidence of almost 10%.”
Worse yet, patients who become pregnant while implanted with Essure are likely to have an ectopic pregnancy, which is when a fertilized egg stays in the Fallopian tubes rather than moving to the uterus. Ectopic pregnancies are medical emergencies that usually must be treated with surgery. Though the growing egg cannot be nourished properly outside the uterus, it can cause the Fallopian tubes to stretch and eventually rupture, causing potentially-deadly bleeding. Treatment typically involves retrieving the egg and repairing or removing the Fallopian tubes.
Allergic Reactions. Some Essure victims have reported allergic reactions to the Essure implant. Typically, these reactions have led to severe rashes, hair loss, and nail loss. This type of reaction is generally linked to a hypersensitivity to the Essure device itself.
Some have even developed chronic autoimmune diseases such as eczema, celiac disease or lupus after receiving the implants. Bayer was heavily criticized by medical experts during the the FDA’s recent Essure panel review meeting for not conducting research on metal allergies, especially considering that metal sensitivity is relatively common in women.
Incorrect or Improper Device Implantation. As reported, doctors who regularly performed Essure implantation have found the procedure both difficult and unreliable. This has lead to women receiving misplaced implants, which requires an operation to correct.
For example, Dr. Charles Monteith, a former Planned Parenthood director who placed over 200 Essure devices, told the FDA that he greatly disliked the inconsistency of the procedure, saying that he was “never sure” it would go as planned despite extensive experience with it.
Device Migration. Another complication related to incorrect or improper Essure device implantation is implant migration. Essure implants can fall out of the Fallopian tubes and migrate into various places within the pelvic cavity. Various issues can lead to migration, including but not limited to improper positioning, poor fitting, damaged device metal, or weakened device metal.
As they are designed to cause inflammation at the implantation site, the implants can cause widespread internal damage after migration, including organ adhesions and uncontrolled scarring.
Uterine & Intestinal Perforation. If the device does migrate, the metal Essure coils can piece through and perforate the uterus, internal organs, and other internal intestinal structures. Unfortunately, this can happen during the implant procedure as well as after device migration. This type of damage can require extensive and repeated surgeries to fix. Moreover, victims of perforation and internal structure punctures are typically not aware of the damage until months after it occurs.
Other patients may remain unaware that their implants are puncturing organs until they undergo Essure removal surgery or hysterectomy to treat pain or other symptoms.
Death. “According to the FDA, at least 9 Essure-related deaths have been reported so far, including 3 adult deaths attributed to placement or removal surgery complications, a case of suicide, and 5 fetal deaths from Essure pregnancies.”
However, the FDA’s fetal death count may be vastly underestimated. In mid-February 2016, a private data analyst named Madris Tomes announced that after analyzing Essure adverse reports from the database on the FDA website, she uncovered a total of 303 fetal deaths. She believes she was able to find a greater number of deaths in her analysis because she included a wider selection of relevant search terms—rather than only looking for “deaths,” she included terms such as “stillbirth” and “stillborn.”
“Surgery-Free” to Multiple Operations – Essure Problems
Although Bayer markets Essure as surgery-free option to permanent birth control, medical boards, hospitals, and insurance companies classify this hysteroscopy as a surgical procedure.
Furthermore, those who experience complications may require multiple surgeries to fix placement mishaps or other errors. Dr. Art Sedrakyan, lead researcher on a recent study that found Essure patients 10 times more likely to require re-operation than those who get their tubes tied, points out that trying to avoid surgery by receiving Essure may instead lead to patients to undergo correction surgeries more invasive and riskier than the laparoscopic tubal ligation they could’ve had in the first place.
Essure Removal Procedures – Hysterectomy – Essure Problems
Essure patients who suffer from severe side effects and complications typically have to seek experts to promptly remove the device. Many have even had to undergo a full hysterectomy. Unfortunately, only a few doctors are adequately trained in proper removal of Essure coils. Even worse, the Essure removal procedure is not covered by all insurance companies, even if the initial implantation procedure was covered.
During the September 2015 FDA panel meeting regarding Essure effectiveness and safety, multiple speakers showed dismay and disapproval at the glaring lack of available options for women to have their implants safely removed. As patient advocate Cynthia Chauhan puts it, “[I]f you do not have access to someone who can remove successfully, you should not be implanting.”For women who develop chronic autoimmune disorders from Essure, life may never return to normal.
Black Box Warning – E-Free Act – Ariel Grace’s Law
The FDA’s proposed black box warning for ESSURE came out months ago, yet still hasn’t actually been approved or mandated yet. Therefore, Bayer had not implemented this warning. However, some members in Congress are still trying to force the FDA to pull Essure from the market by enacting the “E-Free Act.” This proposed bill is demanding a retraction of the FDA approval.
Another bill intended to help women suffering from complications due to the permanent birth control device, Essure, has made it to the house floor. The bill known as Ariel Grace’s Law was filed with the intention to hold medical device manufacturers responsible for any complications, injuries or deaths associated with their product. Ariel Grace’s Law is named after the stillborn child of a woman whose Essure device did not function properly.
Unglesby Williams – Essure Lawyers – Essure Victim Advocates
While fighting Bayer in the courts on behalf of over 1000 women, we have continued to uncover more and more alarming data about Essure, Essure Problems, and how Essure Problems are being reported by Bayer to the FDA. If you or someone you know has been injured or experiencing side effects from the ESSURE Birth Control Implant, contact Unglesby + Williams or call 844-ESSURE-LAW today.
Unglesby + Williams is at the forefront of Essure Litigation, and we will fight for you to get the compensation you deserve.