Report: Bayer to Discontinue Essure After FDA Restrictions, Decline in Sales

Attorneys are currently investigating allegations of adverse health events associated with a permanent form of birth control known as Essure. After continued monitoring and possible penalties imposed by the U.S. Food and Drug Administration (FDA), Bayer AG has decided to discontinue sales of Essure, a permanent contraceptive device that does not require surgery. Some women have reported serious complications to the FDA related to the birth control devices, including organ damage, migration of the devices, persistent pain and other types of reactions. Affected patients and their families may be able to pursue a claim and seek compensation with the help of an Essure implant lawsuit attorney.

If you or a loved one have been adversely affected by a potentially defective medical device, contact Attorney Group to learn about your options. We offer free, no obligation consultations. 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.

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What is Essure?

Essure is a permanent birth control implant. According to the manufacturer, German pharmaceutical company Bayer AG, Essure requires no surgical incision, leaves no visible scars, and can be completed in the patient’s doctor’s office. Small inserts are placed into a patient’s fallopian tubes, working to form a natural barrier to prevent pregnancy without the use of hormones. The devices were originally developed by Conceptus, Inc., now a subsidiary of Bayer AG.

According to the FDA, approximately 750,000 women use Essure worldwide. Essure may be appropriate for women who do want any more children, want a permanent form of birth control, seek a sterilization procedure that does not require surgery, or want a permanent birth control method that does not involve hormones.

Essure Risks

Some patients implanted with the Essure contraceptive device claim to have experienced serious and sometimes painful adverse events. According to the FDA, those events include “perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions.” Likewise, reports indicate that some doctors may have not always been telling women about the risks associated with the device’s risks.

Short-term risks reported in clinical trials include mild to moderate pain, cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, and pelvic or back discomfort. Long-term risks reported in clinical trials include unintended pregnancy; abdominal, pelvic or back pain; and perforation of the uterus or fallopian tubes. Some patients also reported that inserts were found to have migrated to the abdominal or pelvic cavity.

Women have also reported other side effects, including:

  • Headache
  • Fatigue
  • Weight changes
  • Hair loss
  • Mood changes (including depression)
  • Allergy or hypersensitivity reactions
  • Joint or muscle pain
  • Muscle weakness

According to the FDA, “scientific evidence shows that Essure is an effective means of sterilization when health care providers and patients follow the appropriate instructions for use.” However, no form of birth control is completely effective, and patients are advised to seek the assistance of their health care provider before having the device implanted.

FDA Warnings

The FDA has issued multiple warnings and orders with regards to the safety and efficacy of the Essure contraceptive device. Those warnings include:

  • In April 2018, the FDA issued an order “to restrict the sale and distribution of the Essure device to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions.” The order was issued after the agency became aware that some women were not being adequately informed of the device’s risks before getting the device implanted.
  • In November 2016, the FDA required Bayer to add a boxed warning noting specific adverse events associated with the devices, “including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.”
  • After carefully considering public comments, the FDA issued a final guidance titled, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants for Sterilization” in October 2016. The guidance sought to improve the medical device labeling for permanent birth control methods, including Essure and similar devices.
  • In February 2016, the FDA ordered Bayer to conduct a post-marketing study in order to determine increased risks for particular women. The FDA reported that the study, which Bayer will be required to develop and conduct, is designed to highlight important information about the risks associated with the devices, compare them to laparoscopic tubal ligation, and evaluate how such complications might affect a patient’s quality of life.
  • In September 2015, the 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 in order to better understand the benefits and risks of the permanent birth control implant. In their review, the FDA noted over 16,000 complaints submitted to Bayer by patients who had been placed with the Essure devices.
  • In 2013, patient labeling was updated to include risks of chronic pain and device migration.

Since Essure’s approval in 2002, the FDA has monitored the medical device’s safety and effectiveness in order to inform the public about developments related to adverse events associated with Essure.

Bayer to Discontinue Essure in the United States

After December 31, 2018, Bayer will no longer market or sell Essure contraceptive devices in the United States. According to multiple reports (including one issued by the FDA), Bayer made the announcement due to declining sales of the product. The company said it would continue to implement the restriction on the sale and distribution of the device although it maintained that its product was safe to use. Bayer’s decision to halt sales was reportedly not due to any issues related to the FDA’s restrictions or product safety, rather a decline in the amount of women choosing to use the device for their contraceptive needs.

Bayer Contraceptive Lawsuit Claims

Thousands of women have reportedly filed lawsuits against Bayer claiming that the permanent birth control devices led to serious health complications. According to Bloomberg, the number of lawsuits has “surged” since the manufacturer added additional safety warnings to the device labeling. The report also indicates that the largest group of lawsuits has been consolidated in California state court, and that some lawyers plan to hold discovery proceedings in that court as soon as 2019.

Lawsuits also allege that Bayer failed to adequately train the plaintiff’s implanting physician, entrusted the physician with special surgical equipment he was not qualified to use and distributed the product in an unreasonably dangerous manner. Likewise, plaintiffs claim to have suffered serious health complications, including heavy menstrual bleeding, cramping and pelvic pain.

Although a number of lawsuits have been filed against Bayer, it is not expected that there will be early Essure settlements. Complex cases that involve multidistrict litigation or state court consolidated proceedings may be followed by a set of initial trials, known as bellwether trials. 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 could follow this pattern, although the outcome of any case is never guaranteed and past results are not necessarily predictive of future outcomes.

Deadlines associated with the Essure litigation may develop due to the discontinuation of the device.

Has There Been an Essure Recall?

Since the devices’s approval in 2002, the FDA has not notified the public of an Essure recall. Recalls may be conducted by the drug manufacturer, by FDA request, or by FDA order, and in March 2015, more than two thousand women signed a petition calling for a recall of the Essure permanent birth control device. The FDA responded by stating that it would not initiate a recall and considered the petition closed.

Potential litigation could possibly claim that the medical device manufacturers failed to disclose known risks and complications associated with the birth control implants and that patients suffered damages as a result. Failure to warn of side effects of a medical device can be a basis of medical device liability, regardless of whether the device has been recalled.

How an Essure Implant Lawsuit Attorney Can Help

Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they are required to provide adequate warnings. If a device maker or manufacturer fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

People injured by Essure or other similar contraceptive devices may be eligible to recover money for:

  • Medical Expenses
  • Lost Wages
  • Pain and Suffering

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.