The U.S. Food and Drug Administration (FDA) approved Essure in 2002 and promoted it as a safe and effective method of permanent birth control. It was initially met with great enthusiasm as it was a non-surgical procedure that could be done in a doctor’s office without general anesthesia, with a virtually non-existent recovery period. However, the FDA approval was based on studies that examined the cases of less than 1,000 women. At the time of approval, it is alleged that the FDA was not aware that Essure was potentially dangerous.
However, since its release on the market, it was reported that the FDA has received over 10,000 complaints of adverse effects including harsh pelvic pain, dangerous coil migration, serious allergic reaction causing autoimmune problems, among other issues allegedly due to Essure implantation.
How Essure Works
The Essure birth control device consists of two small coils, made of a polyester-like fiber and a nickel alloy. It is implanted in the fallopian tubes by way of a catheter through the vagina. The coils are designed to induce scar tissue to form that would block the tubes and keep sperm from reaching the eggs, thereby preventing pregnancy. This is a process that may take three months. During that three-month period, an additional form of birth control should be used to avoid pregnancy to ensure the scar tissue was sufficiently formed to successfully block the tubes.
National law firm Parker Waichman has extensive and successful experience in medical device litigation. Attorneys at the firm are available to answer questions for individuals seeking legal information for potential lawsuits.
Essure Complication Case History
The Washington Post cites a woman who had experienced pregnancy that was normal and uncomplicated. Since she and her husband already had eight children between them, the decision was made seven weeks after her twins were born, to have a “permanent contraceptive” device, Bayer’s Essure, inserted by her obstetrician-gynecologist. The woman originally thought to have surgical tubal ligation (known as having tubes tied), but her physician assured her that Essure was a less invasive and generally preferable form of permanent birth control.
She agreed to the Essure method and followed instructions to use an alternative form of birth control for the three months after the insertion of the device, until the scar tissue had time to form. During this time, she developed problems with her teeth, her hair was falling out in clumps, she was having abnormally heavy periods and severe cramps, she was gaining weight, and battling brain fog and severe fatigue, even after having slept, reports The Post.
However, the woman did not return for the follow-up doctor visit to confirm that the fallopian tubes were sufficiently blocked. When she missed a period, she was completely shocked to find herself, once again, pregnant.
Essure Problems Group
She researched online and found a Facebook group called Essure Problems. She began reading posts from its roughly 16,000 members (this was in 2015, today that number is estimated to be double that). The women in the group wrote of similar experiences, which they attributed to allergic or autoimmune reactions to materials, particularly nickel, in the device. Some women reported that their devices had migrated out of their fallopian tubes and embedded in the uterus or punctured other organs. Some women decided to have the coils removed surgically, and reported winding up with complications from the operations, and often had to have hysterectomies. There was even a sub-group who posted pictures of their “E-babies,” reports The Post.
Reading through the posts, the woman thought her problems might stem from her extreme sensitivity to nickel. She is so highly sensitive to nickel that she is unable to wear her white gold wedding ring for more than a few days at a time due to its nickel content. She notes that her doctor did not ask if she was allergic to nickel, when suggesting she opt for Essure.
Bayer Continues to Profit from Essure
Headquartered in Germany, Bayer says that more than 750,000 devices have been sold worldwide and that sales “continue to grow.” According to data from Essure clinical trials, device insertion fails anywhere from 4 to 12 percent of the time, making actual usage unclear.
The FDA has received over 16,000 adverse-event reports about Essure in recent years. These are official reports concerning symptoms, hospitalizations, or diagnoses that patients, doctors, hospitals or a device manufacturer believe are linked to the device. These reports can prompt the FDA to order a change in labeling, the addition of warnings or, in rare cases, the removal of a device from the market. Among the reports are close to 9,000 surgical removals of Essure, mostly by hysterectomy. “That’s a lot of surgeries for a device that’s considered minimally invasive,” says Madris Tomes, a former FDA analyst. Tomes and other experts in FDA law and regulation note that there is no “magic number” of reports that will trigger an investigation, but complaints can serve as an important sign to the FDA that it should revisit and reevaluate the safety and efficacy of a drug or device, The Post reports.
The FDA added the warning at the time, because it believed “that some women are not receiving or understanding information regarding the risks and benefits of permanent, hysteroscopically-placed tubal implants that are intended for sterilization.”
Legal Advice and Information Concerning Essure
If you or someone you know has been injured by a medical device, such as Essure, you may be eligible for compensation. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact the personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).