Essure Birth Control Implant Lawsuit
On April 9, 2018, the Food and Drug Administration (FDA) announced it was restricting the sale and distribution of the birth control device, Essure, to ensure that women receive important information on the risks of using the device.
This is one of many actions the FDA has taken over the past few years in response to growing concerns over the serious nature of potential Essure side effects. Because of these issues, the manufacturer—Bayer AG—is now defending about 15,000 Essure lawsuits in courts around the country. Chaffin Luhana is investigating cases in which patients suffered serious injuries or even death because of Essure.
What is the Essure Implant?
Essure is a permanent form of birth control or female sterilization. It is a soft metal spring-like device wound with synthetic fibers that is placed inside a woman’s fallopian tubes. The FDA approved its use in 2002, and since then, the Essure website reports that over 750,000 women have been implanted with it.
The device itself looks like a small spring, like one might find on the inside of a ballpoint pen. The coils are made of nickel, steel, nitinol (an alloy of nickel and titanium), and PET (polyethylene terephthalate) fibers. One of these devices is placed inside each of the fallopian tubes through a minimally invasive procedure called “hysteroscopic sterilization.” The procedure is performed without the patient having an incision made. Instead, the doctor uses a catheter and camera threaded through the vagina and cervix to insert the devices in place. No anesthesia is required, though doctors may use a local numbing anesthetic.
Once the devices are in place, scar tissue forms inside the fallopian tubes. Over a period of about three months, this scar tissue builds up to create a blockage that prevents any eggs from being released and prevents sperm from reaching the eggs so the woman does not become pregnant.
The Essure device was first developed by Conceptus, Inc., which was later bought out by Bayer AG in 2013. Originally the device was called the “Selective Tubal Occlusion Procedure (STOP)” permanent contraception device. Bayer bought out the company in 2013 and added Essure to their women’s health products, which includes the Mirena IUD—another birth control device that has been linked with serious side effects.
Essure is meant to reside permanently in the body, but women who have suffered complications sometimes need to have it removed. Because it’s not designed to be taken out, removal can be difficult and complicated.
Essure Side Effects
Thousands of women have reported problems with the Essure device. It may migrate from the tubes, perforate organs, break into pieces, and corrode (because of the metal content), causing further bodily damage. The FDA notes that some women implanted with the device may be at risk for serious complications, including persistent pain, perforation of the uterus or fallopian tubes, abnormal bleeding, and allergy or hypersensitivity reactions.
Between November 4, 2002—the date the device received FDA approval—and December 31, 2017, the FDA received 26,773 medical device reports related to Essure. The most frequently reported problems were abdominal pain, heavier menstrual periods and menstrual irregularities, headaches, fatigue, and weight fluctuations. The most frequent problems reported with the device included:
- possible nickel allergy
- migration of the device or pieces of the device
- dislodged or dislocation of the device
- device breakage
- device operating differently than expected
- difficulty implanting or removing the device
- malposition of the device
There were 40 reports of deaths, including 10 adult deaths, 20 incidences of pregnancy loss, four infant deaths, and two ectopic pregnancies. The FDA has also received over 1,800 reports of pregnancies in patients receiving the Essure devices between 2002 and 2017. Of those, 365 live births were reported, and 875 pregnancy losses. Over 600 didn’t indicate in the reports whether the pregnancy resulted in a live birth or not. Of the losses, 327 were ectopic pregnancies. The FDA noted that confirming whether the device caused these events is difficult based solely on the reports.
FDA Takes Action to Warn Doctors and Women About Essure
When the FDA first approved the Essure device in 2002, it required the manufacturer to conduct two additional post-approval studies. The first study looked at data from participants in the premarket clinical trials to evaluate how effective Essure was preventing pregnancy, how safe the implanting procedure was, and show safe the device was after it was implanted.
Results showed that some of the women experienced complications, including perforations and expulsion of the device. The FDA, however, stated that “overall results from this study did not demonstrate any new safety problems or an increased incidence of problems since the time of device approval.”
The second study evaluated the implantation procedure, to evaluate training procedures and updating the labeling.
Despite the outcomes of these studies, the FDA remained concerned about the increasing number of medical device reports submitted to the adverse event database. In September 2015, the FDA held a public meeting of the Obstetrics and Gynecology Devices Panel to discuss data pertaining to Essure’s safety and effectiveness.
At the meeting, scientific and medical experts and women who had suffered from problems with the device were heard. The committee was then asked to provide recommendations regarding the appropriate use for the device, product labeling, and the potential need for additional studies.
In a summary of the meeting, the FDA noted that the panel discussed a range of events associated with Essure, including persistent pain, perforation of the uterus and/or fallopian tubes, device migration, abnormal bleeding, allergic reactions, pregnancy, and device removal.
The FDA talked about a need for “better patient materials to support their decision-making process,” and expressed a desire for additional post-market data to better understand the risks. It also suggested that patients with known sensitivities to metal, those with autoimmune diseases, and those with a history of pelvic inflammatory disease may be at a higher risk for developing side effects.
On February 29, 2016, the FDA took additional action to find out more about Essure by issuing a new, mandatory clinical study to determine risks for particular women. The FDA also made clear its intent to change the product labeling to include a boxed warning, the most serious type of warning, “to help to ensure women receive and understand the benefits and risks of this type of device.” It further released a draft guidance for public comment.
On September 2, 2016, the FDA approved an additional study plan to help better understand certain Essure complications. Then on October 31, 2016, it issued the final guidance for the device, taking into account the advice from the 2015 panel meeting, as well as public comments. The FDA also advised that certain new information should be added to the patient and physician labeling, including:
- a boxed warning on the product to help increase awareness of potential Essure side effects and complications, and
- a “decision checklist” with key items about the device, its use, and safety and effectiveness outcomes, “which the patient should be aware of as they consider permanent birth control options.”
Finally, on April 9, 2018, the FDA announced that they were restricting sales of Essure to only doctors and healthcare facilities who use the aforementioned discussion checklist: “Sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation.” These changes were instituted to ensure that every woman was informed of the risks before deciding whether to have the device implanted.
Specifically, doctors must give women the Essure patient brochure. This document includes the patient-doctor discussion checklist, which the patient must review. Once she has read it, she must sign it, and the physician must also sign it before implanting the device.
They also approved Bayer’s new labeling for the product, which includes the checklist and an alert that sales are restricted to facilities that provide the risk/benefit information to patients.
According to CBS News, some public health advocates still don’t believe these changes are enough to protect women, particularly because the product brochure is lengthy and technical, which may discourage some women from reading it before signing their agreement to implantation.
Time to File is Limited
Bayer Halts Sales of Essure in Countries Other than the U.S.
In September 2017, Bayer AG said in a statement that they were no longer going to sell Essure in countries other than the U.S. The company stated that it was making the move for commercial reasons, and denied that it had anything to do with the reported safety issues connected to the product.
Typical Injuries Associated with the Essure Birth Control Implant
The Essure has been associated with the following side effects and complications:
- Abnormal bleeding
- Persistent pain
- Irregular or heavy menstrual periods
- Device migration from the tubes
- Perforation of organs
- Allergic reactions including rashes, fatigue, headaches, and hair loss
- Ectopic pregnancy
- Fetal death
- Migration of the device requiring surgery and possible hysterectomy
Judge Denies Preemption and Allows Essure Lawsuits to Move Forward
Though thousands of women have filed Essure lawsuits, there was concern for a while that these cases may not be allowed to have their day in court. In the Superior Court of California, County of Alameda, Bayer had requested immunity in the lawsuits, stating that because Essure was a Class III medical device approved by the FDA in 2002, the manufacturer was immune from lawsuits concerning the device.
Essure received FDA approval through the rigorous premarket approval (PMA) process, which requires clinical studies to show safety and efficacy. Unlike the less-stringent 510(K) process, which only requires a product be shown to be significantly similar to another product already on the market, the PMA process requires a showing that the device is safe and effective.
Thus, bringing a lawsuit in state court on a product approved via the PMA process is difficult, because the device was subjected to FDA (federal) approval requirements. A Supreme Court ruling in 2008 established that federal preemption applies to devices approved via the PMA process.
Bayer argued that this precedent granted them immunity from having to defend Essure lawsuits. But on August 2, 2016, Judge Winifred Y. Smith in the Superior Court of California denied Bayer’s request, and allowed 11 Essure lawsuits involving 14 women to proceed. The judge found that certain claims were not preempted and allowed some including failure to warn, fraud, negligent misrepresentation, and breach of warranties to move forward. Claims of manufacturing defect and negligent physician training were ruled to be preempted.
This decision has opened the door for other women to bring claims of Essure injuries to court.
Earlier, in March 2017, a Pennsylvania judge allowed Essure claims of failure to warn and negligent misrepresentation to move forward, though he determined that claims of negligent training and manufacturing, fraudulent misrepresentation, breach of warranties, and others were preempted.
Essure lawsuits filed in California have been consolidated in Alameda County for pre-trial proceedings. There are hundreds of lawsuits proceeding there, as well as thousands more throughout the country.
If you or a loved one were implanted with an Essure sterilization product and suffered from a serious injury, you may be eligible to file an Essure lawsuit. Our firm is investigating these cases and we urge you to call us today at 1-888-480-1123.