An Essure lawsuit may be an option for women who have been seriously injured by the allegedly defective birth control implant. Lawsuits claim that the devices led to serious complications such as severe pain, nonstop bleeding, and perforated fallopian tubes. Affected women and their families may be able to recover compensation with the help of a defective medical device attorney.
For more information, contact Attorney Group today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
Have You Seen an Essure Lawsuit Commercial?
You may have seen an Essure lawsuit commercial on television and wondered whether you or a loved one have been affected by Essure and, if so, whether you are eligible to pursue a claim against the manufacturer or others. The purpose of this article is to provide you with additional information so that you have a better understanding of your options.
What is Essure?
Essure is a permanent, non-surgical birth control method for women originally developed by Conceptus, Inc., now a subsidiary of Bayer AG. Designed as an alternative to the standard procedure for surgical sterilization known as tubal ligation, the Essure implant procedure consists of small coil inserts that are placed into the fallopian tubes. Over a period of three months, tissue begins to develop around the inserts, creating a barrier that keeps sperm from reaching the eggs and preventing conception.
Essure is considered a permanent form of birth control and not intended to be removed. Since the product’s introduction in 2002, an estimated 750,000 women worldwide have undergone sterilization procedures with the Essure device.
What are the Risks of Essure?
According to the U.S. Food and Drug Administration (FDA), short-term risks associated with the Essure device reported in clinical trials include:
- Mild to moderate pain during and immediately following the Essure placement procedure
- Cramping, vaginal bleeding, dizziness, and pelvic or back discomfort immediately following the procedure
Long-term reported adverse events associated with the use of Essure include:
- Persistent pain
- Perforation of the uterus and/or fallopian tubes
- Intra-abdominal or pelvic migration
- Abnormal or irregular bleeding
- Allergic reactions
- In some cases, incomplete patient follow-up has resulted in unintended pregnancies
Other reactions following Essure placement not reported in clinical trials but included in medical device reports submitted to the FDA include:
- Joint or muscle pain
- Muscle weakness
- Excessive fatigue
- Hair loss
- Weight changes
- Mood changes
- Persistent fever
Although scientific evidence shows that Essure is an effective means of birth control when patients and health care providers follow the appropriate instructions for use, no form of birth control is 100 percent effective. Based on data currently available, the chance of unintended pregnancy for women who have successfully placed Essure is less than one percent.
Action Taken by the FDA
In a statement released by the FDA, the agency announced that it had been examining safety concerns regarding Essure raised by patients and cited in Medical Device Reports (MDRs).
On September 24, 2015, the FDA called a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss currently available scientific data related to the safety and effectiveness of Essure, hear expert opinions on the risks and benefits of the device, and hear concerns and experiences of women who have used the device.
After careful review of the information currently available, the FDA:
- ordered Bayer, the maker of the device, to conduct a post-market surveillance study to obtain more data about the benefits and risks of Essure;
- intends to require that a boxed warning and Patient Decision Checklist be added to the product labeling to help ensure that a woman receives and understands information regarding the benefits and risks of this type of device; and
- is in the process of completing its evaluation of the trade complaint.
According to a search of the Manufacturer and User Facility Device Experience (MAUDE) database conducted by the FDA, the agency received 9,900 medical device reports related to Essure from the product’s approval on November 4, 2002 through December 31, 2015.
Patient problems most frequently reported were pain/abdominal pain, menstrual irregularities, headache, fatigue, and weight fluctuations.
Device problems most frequently reported were patient-device incompatibility, migration of the device or device component, device operating differently than expected, device breakage, difficulty of removal, malposition of the device, and insertion difficulty.
There have been 26 correctly coded reports of death. Of those reports, six relate to four adult deaths; 18 reports related to 15 incidences of pregnancy loss; and two reports related to two incidences of a death of an infant after live birth.
Lauren A. on May 16, 2016
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Essure Risk of Reoperation
In a 2015 peer reviewed article published in The BMJ, researchers identified over 8,000 patients who underwent hysteroscopic sterilization with Essure and over 44,000 patients who underwent laparoscopic sterilization procedures between 2005 and 2013 in New York. Results indicated that patients who underwent hysteroscopic sterilization using Essure have more than a 10-fold higher risk of undergoing reoperation compared with patients who underwent laparoscopic sterilization.
Essure Lawsuit Claims
Lawsuits allege that Bayer, the manufacturer of the Essure sterilization device, failed to adequately train the plaintiff’s implanting physician, entrusted the physician with special hysteroscopic equipment he was not qualified to use and distributed the product in an unreasonably dangerous manner.
Plaintiffs indicate that had they known that Bayer was concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license, they would never have had the Essure device implanted.
According to one Essure lawsuit, the manufacturers of the Essure device have a duty to exercise reasonable care in warning patient physicians about the dangers of the device that were known or knowable at the time of distribution and have a duty to exercise reasonable care in the manufacture, development, design, marketing, labeling, distributing, and sale of the device after it was approved for sale by the FDA in 2002.
The lawsuit alleges that Bayer failed to do so and therefore violated federal and state regulations as well as Illinois state law. The lawsuit also alleges that the makers of Essure engaged in false and misleading sales and marketing tactics and failed to properly train and educate physicians on the use of the medical device.
Likewise, the Essure lawsuit alleges that the plaintiff suffered from heavy menstrual bleeding, cramping, and pelvic pain. Although the plaintiff underwent a hysterosalpingogram (HSG test) to confirm proper placement of the device, the lawsuit alleges that the plaintiff continued to suffer pelvic pain, and as a result, was required an explant by way of hysterectomy and bilateral salpingectomy (surgical removal of the fallopian tubes).
Has There Been an Essure Recall?
Although there has not been an Essure recall, lawsuits claim that the manufacturers of the sterilization device failed to disclose known side effects of the device and that patients suffered damages as a result. Failure to warn of side effects of a medical device can be a basis of drug company liability, regardless of whether the device or product has been recalled.
Is There an Essure Class Action?
To date, an Essure class action has not been certified on behalf of those injured by the devices. Essure lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the medical procedure. Instead, if multiple Essure lawsuits are filed against the device manufacturers alleging injuries and other damages caused by Essure and similar products, it is anticipated that these lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by pharmaceutical products.
Have There Been Essure Settlements?
Some cases settle early in the claims process, but it is not expected that there will be early Essure settlements. In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments. After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
It is expected that Essure settlements will follow this pattern, although the outcome of any case is never guaranteed and past results are not necessarily predictive of future outcomes.
Essure Lawsuit News
- March 2017Lawsuit alleges that the makers of the Essure device failed to warn about the serious health risks associated with the devices, including perforation of the uterus, chronic pain, prolonged bleeding and unintended pregnancies.
- November 2016FDA issues updated safety information about the addition of a boxed warning and a Patient Decision Checklist. The boxed warning includes information about the significant side effects or adverse outcomes associated with the devices. The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes.
- April 2016An Essure lawsuit was filed in Illinois alleging that the makers of the Essure device failed to warn patient physicians about the dangers of the device and engaged in false and misleading sales and marketing tactics.
- February 2016The FDA issued actions to provide important information about the risks of Essure. A new, mandatory clinical study was issued to determined heightened risks for particular women. Additionally, the FDA announced that it intends to require changes to product labeling, including a boxed warning and Patient Decision Checklist.
- November 2015Pennsylvania Representative Mike Fitzpatrick (R-PA) introduced a bill to congress to take Essure off the market.
- October 2015According to an article posted to NBCnews.com, researchers found that women who used Essure had 10 times as many operations to fix problems as women who had surgery instead.
- September 2015The FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee and reviewed all currently available information regarding Essure to examine the benefits and risks of the device. In their review, the FDA noted over 16,000 complaints submitted to Bayer by patients who had been placed with the Essure devices.
- September 2015An Essure lawsuit was filed in California alleging that the manufacturer knew that the Essure device was dangerous and defective; concealed the dangers and health risks from the Plaintiff, physicians, pharmacists, other medical providers, the FDA, and the public at large; and made misrepresentations about the safety and efficacy of the device.
- May 2014An Essure lawsuit was filed in Philadelphia alleging that the manufacturer failed to adequately train the plaintiff’s implanting physician and distributed the product in an unreasonably dangerous manner.
- September 2013According to an article posted to CBS Los Angeles, a woman in California experienced excruciating pelvic pain after receiving an Essure device in 2011. After a doctor performed a pelvic exam, the woman underwent a full hysterectomy, which included removing the Essure device.
How an Essure Lawsuit Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
Women who have been injured by the Essure birth control device may be entitled to compensation for damages resulting from injuries. Compensation can be based on factors including:
- Medical expenses
- The permanency of the injury
- Pain, suffering, and mental anguish
- Loss of income or ability to work
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
Patients who have suffered severe complications from the Essure birth control device, as well as the families of those who have died as a result of complications with the device, are encouraged to seek the advice of an Essure lawsuit attorney to learn more about their rights and remedies.