Essure Lawsuit FAQs – Birth Control Complications
If you have developed serious complications as a result of an Essure birth control implant and are considering a lawsuit, contact our product liability lawyers for a free and confidential consultation by filling out the online form below by calling my office directly at (215) 948-2718. You can read more about our Essure lawyers at the bottom of this page.
This website answers frequently asked questions about Essure complications and the law, including:
- What happened?
- What steps has the Food and Drug Administration taken regarding Essure?
- Are there class action lawsuits? Have there been any settlements?
- Who might have a claim?
For more about Essure removal, click the link. Or, keep reading for more about Essure lawsuits.
The Essure System, a form of permanent birth control originally manufactured by Conceptus and then bought by Bayer, was first submitted to the FDA in April 2002 and then swiftly approved by the FDA in November 2002. Essure works by inserting a nickel-titanium and stainless steel coils (which are wrapped in polyethlene terephthalate) into the fallopian tubes, where the devices irritate the area into developing fibrous tissue, which blocks the fallopian tube and prevents eggs from descending. Notably, when approving the device, FDA imposed several requirements on the manufacturer, including requirements that the manufacturer create an adequate training program for physicians, that the warning label include information about failure and success rates, and that the manufacturer continue carefully gathering and evaluating data about women’s injuries from clinical trials and from use by physicians. The first Essure lawsuit relating to perforation and migration was filed in 2013. Starting in 2015, Essure lawsuits started to be filed at an accelerating rate, as sales grew, as well as awareness of the problems.
Although FDA had required Conceptus study the safety and effectiveness of Essure within five years of approval, which would have been 2007, those results were, incredibly, not published until April 24, 2015, nearly eight years too late. Even that late study wasn’t done properly: only 70% of women had actually been followed for five years. This shocking delay is sadly common in the medical device industry: as I’ve discussed before, medical device manufacturers routinely game the FDA by not doing the post-approval studies they promised.
Over time, even without the benefit of Conceptus and Bayer doing the studies it promised FDA, it became clear that the stainless steel could rust, the nickel could form an oxide that would cause an immune reaction, and that the device could leak toxic byproducts. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database found that there have been thousands of reports from injured women:
The most frequently reported patient problems during this period were pain/abdominal pain (3353), heavier menses/menstrual irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient device incompatibility (941) (for example, possible nickel allergy), migration of the device or device component (482), device operating differently than expected (301), device breakage (259), and malposition of the device (133).
The hundreds of nickel allergy reports are particularly appalling because, in August 2011, Conceptus convinced FDA to remove the warning against use of the patients with a known hypersensitivity to nickel, then gloated about it in a press release. But the problems continued: in 2013, for example, a group of dermatologists reported a case of “Nickel-induced systemic contact dermatitis” caused by an Essure implant. The dermatologists argued that the release of nickel was likely due the Essure corroding, and that the corrosion and reaction can occur within days after implantation.
The reports also included “one death due to Group A Strep infection post-procedure, one death reportedly due to uterine perforation during device placement, [and] one death related to an air embolism during device removal surgery.” Those are the same types of complications usually seen in conjunction with major surgery, and are not what should be seen in a “nonsurgical procedure,” as Bayer claims about the implantation. (Bayer also makes Mirena. The FDA issued Bayer multiple warnings over its misleading television and internet commercials.)
In November 2014, a team of doctors in Italy reported a case in which an Essure “migrated” from a woman’s fallopian tubes into her abdomen, requiring a follow-up surgery. They then reviewed the available literature and found her case was not unique, leading them to recommend “removal of the migrated device should be performed as soon as possible” and “during presterilization counseling, the patient should also be correctly informed about the risk of this rare but relevant complication, as well as about the surgical interventions that could be required to solve it.”
In October 2015, a study in the British Medical Journal found that, when compared to laparoscopic sterilization, which is the most common form of permanent birth control, women “undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation.” In other words, Essure provides no better birth control for women than a tubal ligation, but has ten times the risk of requiring another surgery within just the next year. But perhaps the most shocking part is that we are just learning about these risks: traditional tubal ligations have long been proven by clinical studies to be generally safe, whereas the British Medical Journal study from just a few months ago was the first serious scientific investigation into the safety of Essure, 13 years after the device started being used on the public. For even more information, see this collection of links I posted at Medium.com.
What steps has the Food and Drug Administration taken regarding Essure?
The problems started early: in July 2003, FDA sent Conceptus a warning letter, noting that Conceptus had failed to do proper quality control in its manufacturing. As complaints about the device began to mount, in December 2010, the FDA performed a two-week inspection of the manufacturing plant, and, soon after, warned the manufacturer that it had failed to report to the FDA and act upon reports of serious injuries potentially caused by the device, including bowel perforations and perforation of the fallopian tubes. (Many of these reports can be found in a heavily-redacted file produced by the FDA.)
In September 2015, the FDA convened an “Advisory Committee” to “review and discuss available data regarding the benefits and risks associated with the use of the Essure System.” Those Advisory Committee meetings are common when a medical device produces an unexpectedly high number of reported side effects and complications. Before the meeting, the FDA produced an 89-page review document, which it summarized on this webpage. The FDA expected to complete its review in February 2016, but actually completed it in October 2016, with a new proposed label. On November 16, 2016, FDA approved a black-box warning that includes:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.
That is a step in the right direction, but I don’t think it’s enough. The warning still suggests to patients that these risks and complications are rare, when the evidence shows that they are disturbingly common. Given the FDA’s slow and inadequate response to transvaginal mesh, I have serious doubts that the FDA would do much further to address the situation, such as by recalling Essure or declaring it to be misbranded under federal law.
Frankly, ABC15 in Arizona deserves more credit than the FDA, given their dogged investigations going back to 2013. Media attention grew in 2015. In April 2015, a woman involved in the clinical trial told the press she believed her medical records had been altered. The New York Times published a thorough review in May 2015, reporting that the FDA “has received more than 4,000 reports of serious complications related to the device, including severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged in other organs.” In July 2015, NPR also published a report, noting “In more than 400 accounts, patients or doctors have reported that Essure coils migrated from the fallopian tubes to other parts of the reproductive system.”
Are there Essure class action lawsuits? Have there been any settlements?
There are no class actions against Bayer. These days, because of a variety of court rulings, it is rare to see class actions involving medical devices. For example, although they each involved tens of thousands of plaintiffs, the DePuy ASR hip lawsuits and transvaginal mesh lawsuits were not class actions. Instead, they were individual lawsuits that were then “consolidated” by court order for case management. That’s usually better for injured people. In a class action lawsuit, the lawyers in charge determine what happens with the case, including when to settle. In consolidated lawsuits, each injured person retains control over their own lawsuit.
As of late 2016, there are numerous cases against the manufacturer of Essure in the federal court in Philadelphia, Pennsylvania (where I am located) and several cases that were just filed in the state court in Santa Clara, California. None of the cases have gone to trial or have reach a settlement. Unlike with many other medical devices, such as DePuy hips and transvaginal mesh, there is no consolidated “multi-district” litigation for the lawsuits.
Many Essure lawyers have taken a “wait and see” approach to these cases. Like all lawsuits involving a medical device that had FDA’s “premarket approval,” Essure lawsuits will have to overcome a legal doctrine known as “preemption.” In short, the Supreme Court has ruled that, when an injured person sues the manufacturer of a “premarket approved” medical device, the injured person must prove that the manufacturer was not only negligent, but also negligent in a way that violated federal law. In every medical device case, the manufacturers try to convince the court that, no matter how negligent or reckless they may have been, they didn’t violate federal law. The arguments over “preemption” are so complicated that the briefs filed by the lawyers can go on for hundreds of pages. In the cases in Philadelphia, Bayer’s “preemption” motion was 63 pages long, and Bayer’s follow-up brief was another 55 pages. The court heard arguments then asked for even more briefing.
Many Essure lawyers are waiting to see if courts decide that these initial cases are “preempted” before filing their own cases. Our firm has decided to move forward and pursue the cases; we believe the evidence is there to overcome preemption, and we believe Essure victims deserve an opportunity to have their cases fought in court. We are also typically filing our cases in Philadelphia state court instead of in federal court. Bayer is based in Philadelphia and so cannot object to injured people filing their lawsuits in Pennsylvania state court.
Who might have an Essure claim?
Based on our review of the complications reported, we believe there are two main types of Essure injury claims.
- Essure lawsuits for additional surgery beyond the implantation. Women have reported a wide variety of surgical complications, including the failure to properly place the implant, tearing or perforation of the fallopian tubes or other nearby organs, movement or migration of the implant afterwards, and the need for subsequent surgeries like a total hysterectomy. We believe the materials provided to patients and to doctors do not adequately warn about these complications, and that Essure was defectively designed, leading to an increase in these complications. If you needed another procedure after the implantation of your Essure, even so-called “minimally invasive” procedures like laparoscopic, then we believe you may have a claim.
- Essure lawsuits for unusual reactions. Women have also reported a wide variety of allergic and immune reactions to Essure, such as metal toxicity, recurrent pelvic pain, and recurrent inflammation. If, after the implant of Essure, you suffered continuing pain or other unexpected complications that were so bad you went back to the doctor, we believe you may have a claim.
Who are the Essure lawyers behind this website?
I wrote everything you see on this website myself. I’m not a an actor on a television commercial or someone in a call center, and this isn’t one of those misleading websites that doesn’t even tell you who is behind it. I’m a real lawyer who has successfully tried serious injury and wrongful death cases in front of juries, and a five-time winner of the American Bar Association Journal’s award for legal writing online. For years, I’ve represented women in gynecologic and obstetrical malpractice cases and women injured by transvaginal mesh implants, recovering millions of dollars for them in compensation.
If you use the contact form below, the email goes to me. If you call (215) 948-2718, it will be answered by me or by my receptionist. But it’s not just about me. I am of counsel with TorHoerman Law, the nationwide product liability firm that negotiated the $2.4 billion Actos settlement and the $650 million Pradaxa settlement. We will bring to your Essure case the same resources, perseverance, and exceptional legal representation.