This website covers the details of the Essure litigation, including the connection to severe abdominal injuries.
Why are Essure Lawsuits Being Filed
Hundreds of claims have been filed against Bayer and Conceptus Inc. (the manufacturers of Essure) by women who have suffered severe abdominal damage when the birth control device moves and punctures the uterus and fallopian tubes.
Attorneys state that if doctors and patients had known the risks, women would have chosen a different form of birth control, such as a hysterectomy, salpingectomy, tubal ligation, tubal fulguration, or application of clips.
What is the Essure Birth Control
Essure is a permanent, non-surgical birth control device for women developed by Conceptus Inc., a company owned by Bayer. Essure was approved for use in the United States in 2002. The insertion of Essure does not require an incision (cut) or general anesthesia, and is also non-hormonal.
During the procedure, which generally takes ten minutes and can be performed in a physician's office, flexible metal coils (including nickel and titanium) are inserted through the vagina and cervix and into the fallopian tubes. Once in place, tissue grows in and around the device over a period of three months and forms a blockage in the fallopian tubes. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.
Three months after the device is placed in the body, a radiologist performs testing to make sure that the fallopian tubes are completely blocked and that the patient can rely on the Essure to prevent pregnancy. A contrast agent (dye) is injected through the cervix, and an x-ray is taken of the Essure coils to make sure no dye leaks past the medical device. Essure is considered a permanent form of birth control and is not intended to be removed. For more information, visit Essure Wikipedia.
Essure received pre-market approval by the FDA in 2002. This approval was based on Conceptus conducting two future studies, which Conceptus failed to do. Additionally, Conceptus received more than 30,000 reports of problems with Essure over its first ten year period. Yet, Conceptus failed to issue a warning to the public about these problems, and failed to notify the FDA of them.
Essure Injuries & Side Effects
According to the Food and Drug Administration, the short-term risks from Essure include mild to moderate pain, cramping, vaginal bleeding, and pelvic or back discomfort.
|Unintended pregnancy, including ectopic pregnancy|
|Migration (movement) of Essure inserts through the fallopian tubes into the lower abdomen and pelvis|
|Perforation (puncturing) of the uterus or fallopian tubes|
|Rash and itching associated with possible nickel allergy|
|Joint pain, fatigue, and other autoimmune disease symptoms.|
If the Essure implant separates, breaks and/or moves, attempted removal often requires multiple surgeries, sometimes requiring removal of the uterus entirely.
The FDA received 5,093 reports of problems related to Essure for the period November 4, 2002, through May 31, 2015. The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.
The most frequent problems have been pain (3,353), heavier menses/menstrual irregularities (1,408), headache (1,383), fatigue (966), weight fluctuations (936), movement of the device (482), device operating differently than expected (301), and device breakage (259).
The FDA has associated the use of Essure with eighteen miscarriages as of December 2015. However, a private consulting firm places the number closer to 300.
Is there a risk of becoming pregnant after being implanted with Essure
According to the manufacturer’s data, this device is 99.83% effective at preventing pregnancy. However, a study published in the journal Contraception that examined the effectiveness of Essure in real-world conditions provided convincing evidence that this percentage is highly inflated.
Non-perfect placement of the device, as well as an incomplete blockage of the fallopian tubes, are some of the conditions that may increase the risk of an unexpected pregnancy. Also, Conceptus’ researchers did not examine women younger than 21 nor older than 45, neither did they follow up with patients after a five-year period.
Real-world data indicated that up to 96 women out of 1,000 (a little less than 10%) would get pregnant within ten years, which is four times more than the risk of pregnancy associated with laparoscopic sterilization (about 2.5%).
Essure Lawsuit Videos
Essure Lawsuit News
FDA mandates new warnings, new data for Essure contraceptive device: The U.S. Food and Drug Administration said it will require a new "black box warning" label for Essure, an implantable permanent contraceptive device. A black box warning in the labeling of products is "designed to call attention to serious or life-threatening risks," according to the FDA website. Monday's announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation. To read more, click CNN News
FDA sets February target for action on much-debated contraceptive implant: Federal health officials aim to release their findings on a much-debated contraceptive implant by the end of February. The Food and Drug Administration posted a brief statement online about its review of the metallic device, Essure, which has been subject to thousands of complaints by women reporting chronic pain, bleeding and headaches. To read more, click U.S. News and World Report
Essure Sterilization Device Causes 'Serious Safety Concern': Study: A new study appears to confirm what some women have said about a permanent birth control device called Essure. Researchers found that women who used the device had 10 times as many operations to fix problems as women who had surgery instead. The Food and Drug Administration is taking a look at the complaints about the device — a pair of metal coils inserted into the fallopian tubes. Thousands of women say they've had problems after being fitted with it, from allergies to the metal used to severe abdominal pain. To read more, click NBC News
Contraceptive implant alarm: Safety fear over popular NHS sterilisation device after women who use it are ten times more likely to need an operation later: Safety fears are raised today about a popular and convenient contraceptive implant provided on the NHS to 1,500 women every year. The Essure device offers permanent sterilization for those who no longer want to have children and takes only ten minutes to insert without needing surgery or general anesthetic. But research published today suggests there is a significant risk the implant can cause health problems. To read more, click The Daily Mail
Experts question safety of birth control implant linked to pain: A 13-year-old birth control implant came under new scrutiny Thursday as federal health experts discussed a host of problems reported by women implanted with the metallic device, including chronic pain, bleeding and fatigue. The Essure implant from German manufacturer Bayer is frequently pitched to women as the only non-surgical option for permanent birth control. But since 2013, the Food and Drug Administration has received thousands of complaints about the device from women and doctors. The agency convened a meeting Thursday to have its outside experts review Essure's safety and effectiveness. The panel's recommendations are not binding. To read more, click CBS News