Essure Permanent Birth Control

Essure Permanent Birth Control

Essure is a birth control system designed to permanently prevent pregnancy without the need for surgical incisions. The procedure can be performed in a doctor’s office in as little as 30 minutes and women can get back to their daily activities within days. Essure is supposed to be a safe alternative to tubal ligation and claims to be over 99% effective in preventing pregnancy. But thousands of women say the device has caused life-altering side effects and are fighting to get Essure off the market.

Essure Birth Control Lawsuits

If you were harmed by the Essure System, you may be entitled to financial compensation. There may be significant payouts and cash settlements awarded to those affected by the Essure device.

Women injured by Bayer’s permanent birth control Essure first began filing lawsuits against the healthcare giant in late 2015 and early 2016. Some Essure cases have been certified as mass tort programs in state courts. Mass torts are different from class action lawsuits, in that cases are filed on an individual basis and not by one plaintiff on behalf of others.

Essure lawsuits are especially difficult to bring to court because of one major obstacle: federal preemption. Essure was granted federal preemption when it was approved through the U.S. Food and Drug Administration’s (FDA) Premarket Approval (PMA) Process. Class III medical devices, such as Essure, must be approved through the PMA process and are therefore subject to stricter and more rigorous premarket clinical studies. It is precisely this requirement that grants PMA-approved devices “federal preemption” and effectively shields the devices from product liability lawsuits.

Essure lawyers and attorneys are working hard to bring Essure claims to court despite federal preemption that supposedly shields Essure from litigation. Numerous battles have already been won in several states where judges have allowed Essure Lawsuits to survive preemption and move forward in the system. This brings women harmed by Essure on step closer to a fair trial.

Essure lawsuits allege a number of legal claims against Bayer, including:

  • Designing a defective product
  • Failing to warn about Essure’s potential risks
  • Breach of implied and express warranty
  • Negligence
  • Fraud
  • Misrepresenting the safety and effectiveness of Essure
  • Willfully concealing the dangers of Essure

Essure Lawsuit Updates

August 2016 — A California state judge allowed the claims of 14 women harmed by Essure to move forward in court, despite Essure’s federal preemption status. The ruling was a positive sign for others trying to bring their own Essure claims against Bayer.

Aug. 30, 2016 — An Idaho federal judge allowed an Essure lawsuit to move forward on one count after striking down the remaining claims on the basis of federal preemption. The lawsuit was brought by a woman who became pregnant with twins after being implanted with Essure.

Sept. 27, 2016 — A judge in California’s Alameda County ruled to create an Essure mass tort program in the state, consolidating about 50 cases pending in California’s state courts at the time.

Oct. 12, 2016 An Illinois federal judge ordered an Essure lawsuit involving 95 plaintiffs back to Illinois state court after Bayer attempted to remove the case to federal court. The judge also denied Bayer’s motion to dismiss the claims of out-of-state plaintiffs.

Nov. 9, 2016 — A New Mexico federal judge sent an Essure lawsuit back to state court, following Bayer’s attempt to remove it to federal court. The lawsuit was brought by a woman who became pregnant following her Essure procedure.

Nov. 14, 2016 — A lawsuit involving more than 180 plaintiffs was sent back to California state court after Bayer attempted to remove it to federal court. A California federal judge remanded the lawsuit back to Los Angeles Superior Court, saying the lawsuit was not removable under the Class Action Fairness Act.

Dec. 2, 2016 — A federal judge in Missouri remanded an Essure lawsuit back to state court in St. Louis after Bayer tried to remove it to federal court. The lawsuit was brought by in- and out-of-state plaintiffs and Bayer argued the out-of-state plaintiffs were improperly joined in the lawsuit.

New Black Box Warning

Essure now comes with a new Black Box Warning to ensure women are better informed about the possible risks associated with the permanent birth control.

The FDA announced it would require the warning following a September 2015 Advisory Meeting regarding the safety and effectiveness of Essure. The FDA signed off on the new warning in November 2016 and the warning was included on the label the following month.

Black Box Warnings are the FDA’s strongest warnings for drugs and medical devices and call attention to the products’ risk of serious injury or death.

What is Essure?

Essure is the only nonsurgical form of permanent birth control (sterilization) on the market today.  The Essure System consists of two metal coils that are inserted into the fallopian tubes to prevent pregnancy. The coils are made from polyester fibers, nickel-titanium, platinum, silver-tin and stainless steel.

Essure was developed by the California startup Conceptus Inc. in the 1990s. The company received approval from the FDA to market the sterilization device in 2002. Because Essure was the first nonsurgical form of permanent birth control of its kind, it received fast-track approval from the FDA through the agency’s PMA process.

Essure is now marketed and sold by global conglomerate Bayer Healthcare. The company  purchased Conceptus Inc. and the rights to the Essure System in 2013 for $1.1 billion. Since its approval, Essure has been used by more than 750,000 women worldwide.

Bayer advertises that Essure is a safe option for women who desire permanent birth control and is over 99.3% effective in preventing pregnancy. There are many women who say the birth control caused unwanted side effects, including pelvic pain, heavy bleeding, migration of the device, perforation of nearby organs, as well as unintended pregnancies.

The FDA held an advisory meeting in September 2015 after thousands of adverse event reports flooded the agency’s MAUDE (Manufacturer and User Device Experience) Database. The FDA now requires a Black Box Warning — the agency’s strictest warning short of a recall — on the Essure label and a Patient Information Booklet that is signed by both the patient and her doctor.

Many women injured by Essure continue to call for the device to be recalled from the market and have urged Congress to introduce legislation that would do just that. Ariel Grace’s Law (H.R. 5403) and the Medical Device Guardians Act (H.R. 5404) are pending in the House of Representatives as of 2016.

How does Essure work?

Essure works to prevent pregnancy by blocking the fallopian tubes to keep sperm from reaching an egg. Essure’s metal coils incite an inflammatory response within the tubes that creates a barrier of scar tissue. This prevents sperm from entering the tubes to fertilize an egg.

Essure is non-hormonal and women will continue to release eggs after Essure is placed. It usually takes about 3 months for scar tissue to form and women must use an alternative form of birth control during that time.

Essure Insertion Procedure

The Essure Insertion Procedure is performed in a doctor’s office without any surgical incisions and is usually completed in less than 40 minutes. This is why Essure is such an attractive option for many women.

Doctors use a small tube to insert the Essure coils into the fallopian tubes through the vagina and cervix. Over the next few months, scar tissue will begin to form around the Essure coils, closing the fallopian tubes and blocking sperm from entering.

About 3 months after the initial Essure procedure, women must return to their doctors for an Essure Confirmation Test to make sure the device is working properly. The Essure Confirmation Test consists of a modified HSG (Hysterosalpingogram), which uses contrast dye and an X-ray of the uterus and fallopian tubes to ensure the tubes are blocked.

Essure Reversals & Removals

Essure is a sterilization device intended to prevent pregnancy indefinitely, but some women may decide they want to remove or reverse their Essure System. The decision to remove or reverse Essure is a personal one. Some women may decide they want more children, while others may find the possible side effects caused by Essure warrant removal of the device.

There are several different procedures doctors use to remove or reverse Essure. The most common procedure is hysterectomy, but this does not restore a woman’s fertility and it takes with it some of women’s most intimate organs. The procedure also carries its own potential risks. During the procedure, doctors typically remove the uterus and cervix (total hysterectomy), along with the fallopian tubes (bilateral salpingectomy).

Hysterectomies increase a woman’s risk for pelvic organ prolapse, which occurs when pelvic organs drop from their original place and push against the walls of the vagina. Hysterectomies may also send women into early menopause even if the ovaries are not removed.

For women who want to try and restore their fertility or who do not want to undergo a total hysterectomy, there are some specialists in the United States who perform Essure removals and reversals that leave the woman’s reproductive organs relatively untouched.

These procedures remove the Essure coils from the fallopian tubes intact without having to remove the entire tube or other organs. However, these procedures risk leaving fragments from the coils behind, which can cause further complications, and should only be performed by an experienced specialist. There are few specialists in the United States who have extensive experience performing these procedures.

Problems & Side Effects

More than 750,000 women have relied on Essure for birth control since it was approved 15 years ago. Thousands of those women have reported side effects from their Essure devices that include chronic pelvic pain, heavy or prolonged menstrual bleeding, migration of the coils, autoimmune reactions and the need for hysterectomy to remove the coils.

One premarket clinical trial used to support Essure’s approval — called the Pivotal Study — involved 544 women who underwent the Essure procedure. The most commonly reported side effects in the study included:

  • Cramping (29.6%)
  • Pain (12%)
  • Nausea/vomiting (10.8%)
  • Dizziness/lightheaded (8.8%)
  • Bleeding/spotting (6.8%)
  • Fainting (1.3%)
  • Fluid buildup in the blood, called hypervolemia (0.4%)
  • Device migration (0.4%)

Other side effects reported included aches, hot flashes, shakiness, feelings of discomfort, feeling weak, profuse perspiration, bowel pain, sleepiness, skin itching, loss of appetite and bloating.

Adverse Events Reported to FDA

Many women who were injured by Essure and their doctors have reported these adverse side effects to the FDA.

The FDA conducted a search of its MAUDE Database and found that between 2002 and 2015, 9,900 adverse event reports related to Essure were submitted. The majority of reports were received after 2013 and were submitted voluntarily by women injured by the device. Many of these reports listed multiple adverse events.

The reports also included many side effects that were not documented during early clinical trials, including extreme fatigue, depression, weight gain, allergy and hypersensitivity reactions.

The most commonly reported adverse events included:

  • Pain/abdominal pain (6,989)
  • Heavier or irregular menstrual periods (3,210)
  • Headache (2,990)
  • Fatigue (2,159)
  • Weight Fluctuations (2,088)
  • Patient-device incompatibility (2,016)
  • Migration of device (854)
  • Unintended pregnancy (631)
  • Device operating differently than expected (490)
  • Device breakage (429)
  • Device difficult to remove (280)
  • Malposition of device (199)
  • Device difficult to insert (187)

Deaths Linked to Essure

A number of deaths have also been linked to the Essure System, including the deaths of 4 women, 2 infants and 15 fetuses. These deaths were reported to the FDA’s MAUDE Database and were revealed in the agency’s search of the system.

Questions Surround Clinical Studies

Essure was approved in 2002 based on 2 premarket clinical trials — the Phase II Study and the Pivotal Study. The studies recruited a total of 926 women to participate, but only 745 women actually underwent the Essure procedure.

The studies found Essure to be both safe and effective for the majority of women, but only followed participants for up to 2 years. At the time of Essure’s approval, the FDA required its manufacturer (then Conceptus Inc.) to carry out a postmarket approval study to ensure the longterm safety and effectiveness of the device.

The study was intended to follow women for up to 5 years and was supposed to include all of the women who participated in the Phase II and Pivotal studies. However, only 80% of Phase II participants and less than 90% of Pivotal participants were followed-up at 3 years, and those numbers fell even further to 75% of Phase II and 82% of Pivotal at 5 years.

Another postmarket study was also required at the time of Essure’s approval and documented whether doctors newly trained in Essure placement were able to insert the coils successfully on their first try.

Since 2002, Essure has been the subject of 6 postapproval studies and 1 postmarket surveillance study.

Questions also surround the early clinical trials that led to Essure’s approval. The Phase II and Pivotal trials did not report some side effects that were later reported by women implanted with the device. The early trials also found that Essure was nearly 100% effective at preventing pregnancy, but since Essure’s approval, the FDA has received more than 600 reports of unintended pregnancies in women with the device.

Allegations that some data from these early clinical trials had been altered by the study sponsor have also been raised. A Citizens Petition sent to the FDA in February 2015 claimed patient data concerning pain and discomfort had been altered to reflect more favorable data for Essure. The FDA investigated these claims and in February 2016 announced it did not find evidence that patient data were purposely altered in Essure’s favor.

FDA Actions on Essure

The FDA held an advisory meeting of its Obstetrics and Gynecology Devices Panel on Sept. 24, 2015 to address issues and concerns raised by women implanted with Essure.

As part of the meeting, FDA and its advisory committee discussed available data on the safety and effectiveness of Essure, heard expert scientific and clinical opinions on the risks and benefits of Essure, and heard from women who were injured by the device.

Meeting participants also discussed recommendations about actions the FDA should take moving forward. This included collecting additional clinical data, improving physician training and education, improving patient counseling and label modifications.

Following the September 2015 Advisory Meeting, the FDA began implementing the following actions:

  • Mandatory Postmarket Surveillance Study The FDA required Bayer to conduct a postmarket surveillance study (also called a “522 study”) to obtain more information about the safety and effectiveness of Essure. Bayer submitted its study plan on March 26, 2016 and the FDA approved it on Sept. 6, 2016. The study is expected to be completed in 2023.
  • Black Box Warning The FDA required Bayer to include a Black Box Warning on the Essure label to better inform women of the potential risks of the device. Black Box Warnings are the agency’s strictest warnings short of recalling the product from the market. The FDA opened up a public comment period regarding the language of the warning to include input from women harmed by the device. The comment period was closed May 3, 2016 and the FDA approved the final language for Essure’s new warning on Nov. 15, 2016.
  • Evaluation of Trade Complaint — Concerns surrounding the clinical trials that led to the approval of Essure were brought to the FDA’s attention in a Citizen Petition. The petition claimed patient records and data had been altered by the study sponsor, including information about certain side effects reported by women in the study. The FDA conducted an investigation into the complaint and announced its findings in February 2016. The agency concluded that less than 1% of patient data had been altered and that it did not find evidence the reports were purposely modified to reflect more favorable data for Essure.

Sources

Bayer, Essure Patient Information Booklet. Retrieved from

http://labeling.bayerhealthcare.com/html/products/pi/essure_pib_en.pdf

 

Bayer, Essure Permanent Birth Control Website – www.essure.com

 

FDA, “Summary of Safety and Effectiveness Data,” Essure PMA (2002). Retrieved from

https://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014B.pdf

 

FDA, 522 Postmarket Surveillance Study. Retrieved from

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=356&c_id=3854

 

FDA, “Re-Evaluation of Case Report Forms Supporting the Initial Approval of the Essure System for Permanent Birth Control” (Feb. 29, 2016). Retrieved from

https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/UCM488062.pdf

 

Bayer, Press Release, “Bayer to acquire Conceptus, Inc.” (April 23, 2013). Retrieved from

http://www.prnewswire.com/news-releases/bayer-to-acquire-conceptus-inc-205177941.html

 

FDA Activities, Essure Permanent Birth Control. Retrieved from

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm