Essure Permanent Birth Control Device Presents Serious Health Risk To Women.
Bayer, the company which designed and manufactured the permanent birth control device known as Essure,is confronted with numerous lawsuits by women claiming that the device caused them severe and potentially life-threatening injuries. Women who suffered tremendous complications from the device have filed claims across the United States. Bayer adamantly denies any wrongdoing.
Parker Waichman LLP is a national lawfirm that represents women who sustainedinjuries from birth control devices like Essure. Parker Waichman’s birth control device lawyers zealouslyrepresent their clients and their families who were injured by the carelessness and indifference companies like Bayer demonstrate when they market products that have the potential to alter a woman’s life for the worse irrevocably. Parker Waichman stands committed to helping you find justice for your injuries and holding Bayer accountable for the damages they caused.
What is the Essure Device?
Essure is a small nickel-plated coil which bears a striking resemblance to a small spring. Physicians insert these coils into a woman’s fallopian tubes. The device irritates the fallopian walls to promote the growth of scar tissue. The scar tissue creates a barrier that prevents egg cells from descending to the uterine wall, prevent sperm from fertilizing the eggs, and, consequently, preventing pregnancy.To put it simply, the device renders the woman sterile.
Implantation of the device is quick and easy and can be done in a physician’s office. Essure does not require surgery to implant and may be accomplished with minimal invasion.Bayer marketed the product as a safe alternative to more traditional permanent birth control measures like tubal ligation (tied tubes) or a hysterectomy.
Unfortunately, ease of administration does not equate with the desired results. Many women suffered severe pain and complications from the implant. Complications included:
- Acute back pain,
- Acute abdominal pain,
- Chronic pain,
- Allergic reactions to nickel,
- Autoimmune responses,
- Undesired pregnancy, and
Removing the Device
Doctors found that Essure created problems that were not easily resolved. While inserting Essure was relatively easy, removing the implants proved to be incredibly complicated and risky. Doctors found that patients suffered complications when the implants disintegrated. Pieces of the device spread throughout women’s bodies within a year or two after insertion. Scar tissue grew as intended but the growth caused parts of the implant to be stuck in place. Additionally, some coils reportedly created a ball or fell out the fallopian tube and into the patient’s uterus.
One of the substantial barriers to relieving patients of the harmful product was the lack of medical literature which doctors could use to guide them through the removal process. Without documentation to guide the physicians safely through the removal process, the women were merely leftto hope that their doctors correctly performed the surgery.
Of course, complications can arise any time a person goes under the knife. The potential for complications increases exponentially when the surgeons are not certain of how to perform the procedure. Leaving a piece of the coil in the body is the most significant concern. Portions of the coil can break away from the largerpart—which is approximately an inch-and-a-half before insertion — and get left behind. The number of surgeons who can successfully perform the removal procedure increased to as many as 30 across the country.
The removal procedure is much more involved than the documentation providing by Bayer that accompanies the product. Bayer’s instructions indicate that the device is permanent and should be removed if the patient experiences problems. Bayer also consults that doctors should order imaging tests like x-rays to determine the cause of the patient’s complaints. Beyond that, doctors have few options. Doctors can remove the entire female reproductive system by performing a hysterectomy or remove the affected areas by resceting the fallopian tubes. Reaching up and pulling it out is not a viable option because that will force the coil to stretch and ultimately break. Such much for Bayer’s claim that Essure is the only “non-surgical,” permanent birth control option.
In January of 2017, the number of claims filed across the country reached 3,700. However, one database suggests that approximately 10,000 women have complained about Essure in one way or another. (One source indicates that perhaps 30,000 women suffered injuries from Essure.) These victims may choose to join the existing lawsuits or file their own. Complaints filed in court typically allege that the women suffered serious complications from using Essure and that the literature accompanying the device did not include any warnings about potential complications.
Bayer, a German company, defends its actions — and its product. Bayer claims that the U.S. Food and Drug Administration (FDA) approved the device and found it safe to use. Therefore, Bayer argues, they cannot be held responsible for the injuries patients suffered because the FDA said it was safe. Essentially, Bayer claimed it was immune from paying damages because it received FDA approval and moved to dismiss the case. A judge in California state court did not find Bayer’s argument on that point persuasive and denied Bayer’s motion to dismiss the action.
Many plaintiffs filed their cases in California courts. However, other cases are now pending in other jurisdictions across the U.S. For example, in North Carolina, a woman sued her doctor, the sales representative for Bayer, and Bayer for medical malpractice, wrongful death, and negligence. In that suit, the plaintiff alleges that she received the Essureimplant, but it did not perform as indicated because the scar tissue did not completely block her fallopian tubes. She became pregnant. Tragically, in or around her fourth month, she began experiencing pain and hemorrhaging. The woman gave birth to a stillborn baby girl.
The woman’s complaint alleges that the salesperson was present during the implantation procedure and coached the doctor on how to perform the procedure. Additionally, the woman alleges that the documentation accompanying the device did not specify the potential side effects while claiming the implants were “safe and effective” for preventing pregnancy.
Bayer continues to advance their defense that federal law pre-empts state law. If that is true, then the plaintiffs are essentially left without a case. Notwithstanding Bayer’s defense, the individual states have a vested interest in making sure that their constituents can seek redress of the grievances in state court, under state law. If a judge found the federal law controlled, then the plaintiffs would have a tremendously difficult case to prove, and Bayer could walk away without having to pay any damages.
Under most state’s laws, a company is liable for damages it causes to their customers from defective products. The plaintiff must prove that the company caused the injuries as a result of mislabeling, deceptive or misleading marketing, design defect, or manufacturing defect. Additionally, plaintiffs can claim that their doctors committed medical malpractice by failing to insert or remove the device properly and failing to discuss the possible complications and ramifications of using Essure.
Protect Your Rights
Parker Waichman LLP is a national law firm who stands ready to fight for you. Call Parker Waichman LLP to schedule a free, no-obligation consultation to discuss your claim, or if more convenient, you can fill out our online form. Time is of the essence, and any delay in contacting us could cause you to give up your rights forever. Call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) and speak with one of our experienced Essure lawyers about your rights.
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