Article at a Glance
- Essure is a form of permanent birth control on the market since 2002. Generally, it’s been without incident, but a growing number of women have reported injuries and are discontinuing Essure use. Side effects range from severe cramps to tooth infections, device failure, and autoimmune reactions.
- The FDA has taken at least five actions over the years against Essure, the most recent in 2018, when it announced it would be restricting sales of Essure.
- More than 16,000 lawsuits have been filed against the manufacturer of Essure. If you think you’ve been injured by Essure and you live in Ohio, contact one of our experienced medical device attorneys today.
Essure is a permanent, irreversible birth-control device for women that was put on the market in 2002 by Conceptus, Inc. Essure is made of two sets of small coils that are inserted through the vagina and cervix into the fallopian tubes in a medical procedure that takes about 10 minutes. It does not rely on releasing hormones, but rather causes scar tissue to form that is a barrier to prevent pregnancy.
It takes about three to six months after insertion before Essure can prevent pregnancies. In 2013, the multinational German conglomerate, Bayer, acquired Conceptus. Most women have used Essure without incident. However, a significant number suffered extremely serious injuries without adequate warning.
This post will discuss those injuries and other potential Essure side effects, FDA actions and litigation against Essure, and how to get help if you have been injured by Essure.
The History of Essure
Initially, Essure was warmly welcomed by the medical community. Before Essure, the only permanent way to prevent pregnancy was through tubal ligation, which is major surgery that involves external scarring, anesthesia, and all the other attendant risks of surgery.
Many saw Essure as a godsend for women who wanted no more children, did not want an accidental pregnancy, and did not want to take hormones for years. Essure could be placed in a doctor’s office in about 10 minutes, and it reduced the risk of pregnancy to about 0.1% when the procedure was done properly. (However, note that Essure insertion failed 4-12% of the time, according to Essure clinical trials.)
Instead of needing days to recover from major surgery, women could walk out of the doctor’s office after Essure implantation and go about their normal day. Expectations for Essure were so high that the FDA granted it an expedited review, saying it was because the device offered “significant advantages over existing approved alternatives.”
Women Begin to Report Alleged Essure Injuries
Women began to report serious medical symptoms and injuries after they had Essure implanted. In April 2018, the FDA reported that from the date Essure was approved — November 4, 2002 — until the end of December 2017, there had been 26,773 reports of problems. Women had reported teeth getting so infected they had to be pulled, hair falling out in clumps, pain, joint problems, muscle weakness, skin rashes, severe cramps, weight gain, fatigue, brain fog, headaches, and device failure resulting in pregnancy.
Many of the symptoms appeared related to autoimmune reactions. Sometimes the Essure device migrated from the fallopian tubes and became embedded in the uterus or punctured other organs. Many women who wanted the device removed after suffering problems had to have hysterectomies.
The FDA also received reports of the deaths of eight women that were claimed to be related to Essure.
What caused Essure’s dangerous side effects?
Essure is manufactured using Nitinol, a nickel-titanium shape-memory alloy. Once inserted, the coils would expand, and fibers made of polyethylene terephthalate (PET) would cause acute inflammation that caused the scar tissue that would stop pregnancy.
Nitinol had been used in previous devices, but there had been extensive publication on the hypersensitive reaction to the nickel in it by some people, many of the same reactions experienced by Essure users. An additional concern was that perhaps the inflammation caused by the device triggered an increase in autoimmune disposition.
FDA Actions Regarding Essure
Before putting Essure on the market, Conceptus had to submit it for review by the FDA’s Center for Devices and Radiological Health. Standards for approval of devices are less than for drugs which must go through more stringent clinical trials.
The FDA took the following actions through the years regarding Essure.
Essure was given an expedited review before being granted approval as a Class III medical device, a designation generally reserved for the highest-risk medical devices. Class III devices are supposed to be put through premarket approval, the strictest application process for devices. But Class III devices such as Essure are protected from most lawsuits because of a 2008 Supreme Court decision.
Women using Essure were only followed for one year before Essure was put on the market, but Conceptus was ordered to follow women from the study for five years as a condition of the expedited approval. Conceptus submitted the data to the FDA in 2008, but the FDA did not make it public until 2014. But 30% of the women in the study were not followed for five years because if they got pregnant or developed a complication, their data was not reflected in results.
As time went on, more and more women complained of symptoms after being implanted with Essure. Doctors often dismissed the women and told them it was all in their heads. It should be noted that it was more lucrative for doctors to implant Essure than to perform tubal ligations. Conceptus estimated a doctor would net $1,100 for each Essure implant but only $510 for each tubal ligation. Due to women’s growing activism and demands for meeting with the FDA, in 2015, the FDA held a hearing on Essure.
That 2015 hearing resulted in the FDA issuing a “black box” warning in 2016. This is one of the strongest warnings the FDA issues and it is rarely given for devices. The warning was issued because the FDA believed that some women were not adequately being informed of the risks attendant with Essure implantation. In the two years since adding the warning to the box, U.S. sales of Essure have dropped 70%.
The FDA also ordered Bayer to conduct another clinical trial using a control group. Initially, no control group was used, because the FDA assumed there was no need, citing ample existing data on women who had undergone tubal ligations, the alternative to Essure. The trial was to be conducted over three years, and the results will be due in 2023.
In April 2018, the FDA announced that it was restricting sales of Essure to health care providers and medical centers that could guarantee women would be fully informed about Essure’s risks by reviewing a checklist of side effects before the device was implanted. Both the patients and the doctors must sign this checklist. This is new, because though the black box warning was ordered by the FDA in 2016, there was no order for doctors to conduct a review of side effects with patients.
The FDA commissioner said this action was needed because some patients were still not being properly informed of the risks of Essure.
Essure Litigation and Settlements
According to a recent financial report from Bayer, Essure users have filed over 16,000 lawsuits against the manufacturer. There have been no large publicized settlements to date and no verdicts. Bayer has claimed some losses due to lawsuits, but these losses do not involve compensation paid to plaintiffs for injuries. They merely reflect a change in the market as women have become more reluctant to use Essure.
All lawsuits are individual actions for now, but that could change. Bayer has tried to get lawsuits dismissed due to preemption laws that shield companies from lawsuits for medical devices that have gone through rigorous Class III tests before FDA approval. However, some judges have allowed lawsuits based on specific incidents of negligence in the manufacture, risk management, and breach of express warranty of the product. Many lawsuits, however, have been dismissed on procedural issues. For example, in January 2018, a Missouri judge threw out 92 of 95 plaintiffs in an Essure product liability case because the plaintiffs were from out of state. The judge said they should not have filed in Missouri even though that was the location of the Essure clinical trials.
Can I sue if I suffered an Essure injury?
Litigation against Bayer for Essure injuries and Bayer’s failure to adequately warn patients about the risks of using Essure is ongoing. If you have suffered pain, an injury, or symptoms you feel are due to Essure implantation, you should contact an experienced Ohio products liability attorney like Plevin & Gallucci immediately. The law limits the amount of time in which you have to file a claim, so act quickly.