Essure “Permanent” Birth Control Lawsuits
Have you or a loved one ever used the Essure birth control device? If so, have you suffered failure, perforation, implant migration, nickel allergic reactions, blood clots, hemorrhages or other complications from the device that required surgery or removal?
What is the Essure Birth Control Device?
The Essure birth control device, invented by Conceptus, purchased and now sold by Bayer, is a four-centimeter metallic coil with a polyethylene terephthalate (PET) fiber core. The coils are designed to be inserted into the fallopian tubes where they cause intense inflammation. This inflammation blocks the fallopian tubes causing “permanent” sterilization of the patient. Scar tissue forms over the coils, completing this “permanent” sterilization.
The device was approved, via dubious FDA actions, on November 4, 2002. Due to its nature as an implanted medical device intended to “protect, maintain, and enhance” a patient’s health and life, the FDA classified the Essure device as a Class III medical device. However, the FDA website also explains that Class III devices are those that “may present a potential unreasonable risk of illness or injury” or “for which there is insufficient information to make such a determination.” Further, “neither general nor special controls would provide a reasonable assurance of safety and effectiveness.”
What is the Problem with Essure?
If Conceptus, during the FDA approval process, had reported the almost 17,000 adverse events for which it had received reports, perhaps the device would not have been approved. If one of the members of the FDA review board wasn’t also consulting with Conceptus, perhaps the device would not have been approved. If the FDA had done its job and ensured that the eight-plus violations for which it cited Conceptus were corrected, perhaps the device wouldn’t be such a hazard. However, due to a “profits over patients” mindset, as well as a blatant conflict of interest, the device was approved and hit the market.
Essure has been aggressively marketed as the only non-surgical sterilization option, in that it requires neither incision, nor general anesthesia. It is also a non-hormonal sterilization method. The procedure, performed in your doctor’s office, is done via vaginal/cervical insertion with no or minimal pain mitigation.
Women are advised to continue their normal birth control practices for three months post-implantation. At the end of this three-month period, women must undergo a radiological confirmation test to determine whether the fallopian tubes have been fully blocked. This Essure Confirmation Test with a modified hysterosalpingogram (HSG) involves a dye (contrast agent) injected through the cervix. Following the injection, an x-ray is taken to confirm that the dye doesn’t get past the Essure coils. If no dye passes the coils, the implantation is considered successful and patients can stop using other forms of birth control.
The Essure coils are made of titanium and nickel, along with the PET fibers. While titanium is a common metal used in implanted medical devices, nickel is not. In fact, it is well known that nickel often causes serious allergic reactions in many women. Think of the skin irritation that many women experience from nickel jewelry; now, imagine that material implanted in a woman’s fallopian tubes. It’s a horrific thought.
The PET fibers have an unintended effect in that they often engage the body’s immune system to fight what is seen as a foreign body or an infection. This immune response can cause a host of other problems, ranging from kidney, adrenal and thyroid disorders, neurological issues, autoimmune conditions, hair and tooth loss, cancer and even death.
Additionally, the Essure coils have been known to migrate. When this occurs, the fallopian tubes are perforated. In some instances, the coils also perforate the uterus, colon and other organs. They can also cause adhesions (unrelated tissues becoming joined together), which can require surgical correction.
The FDA states that the short-term risks of the Essure device are mild to moderate pain, cramps, vaginal bleeding and pelvic/back pain. The long-term risks include:
- Pelvic pain
- Device migration (fallopian tube perforation, allowing the device to embed in the lower abdomen and pelvis
- Severe weight gain (women report that they are often mistaken as being pregnant)
- Itching and rashes, possibly caused by nickel allergy or PET fiber-induced autoimmune response
- Hemorrhaging, including prolonged heavy menstruation
- Pregnancy (including ectopic pregnancy where the embryo attaches to the inside of the fallopian tube)
- Fetal deaths due to placental abruption – the detachment of the placenta from the womb (over 300 fetal deaths reported)
Pregnancy? After “Permanent” Sterilization?
Yes, pregnancy. While Bayer insists that the Essure device is 99.83% effective in permanently sterilizing those women who have the device implanted, independent data proves that this is a blatant lie.
The journal Contraception published a study in which it was shown that roughly 10% of women with the Essure device would still become pregnant within ten years. This is four times the failure rate of traditional laparoscopic sterilization (tubal ligation), which is approximately 2.5%. The study suggested that this 10% failure rate may be due to improper device placement and/or incomplete blockage of the fallopian tubes. It also stated that Conceptus failed to examine women less than 21 years of age and over 45 years of age. The company also failed to conduct follow-up with implanted patients after a five-year period.
Two different pieces of legislation have been introduced that would permit women injured by the Essure device to pursue legal action. One is Ariel Grace’s Law, inspired by the loss of an “E-Baby,” as babies born to women with Essure have come to be called. Ariel Grace, like many E-Babies, was born prematurely and did not survive.
Another piece of legislation is the E-Free Act. This bill would also allow injured women to pursue legal action against Bayer. Currently, due to Essure’s status as a Class III medical device and its level of FDA approval (PMA or pre-market approval), no legal action can be brought against the company due to a legal mechanism called “preemption.”
A U.S. Supreme Court decision in Riegel v. Medtronic, Inc. shored up preemption, much to the satisfaction of medical device manufacturers. According to the defendants in Riegel, “Federal preemption remains one of the most powerful defenses available to a medical device manufacturer facing a tort lawsuit involving a product approved by the FDA’s Premarket Approval (or PMA) process. It has the potential to dispose of product liability claims regarding the design, manufacturing and labeling of a medical device early in a lawsuit, such as by a pleading-stage motion to dismiss or on an early motion for summary judgment, without the need for extensive (or any) discovery.”
FDA Response (or lack thereof)
The agency got 5,093 adverse event reports on Essure from November 4, 2002 to May 31, 2015. Most of the reports since 2013 have been from patients, with some coming from health care providers. The number of reports has jumped to over 10,000 since 2015.
The FDA held a safety review of Essure in 2013. The reports behind the review came from patients and health care providers and documented the following:
- Abnormal menstruation
- Device fragmentation
- Pelvic pain
- Device migration
- Hysterectomies due to Essure complications (it should be noted that women as young as their 20s are having hysterectomies)
On September 24, 2015 the agency held a public hearing to help an advisory panel issue recommendations to the agency as to what its next steps should be. Despite the following, the Essure device was allowed to remain (and still remains) on the market.
“Post-Market Regulatory Violations
Eight FDA 483 citations:
- Significant objectionable conditions
- Violations of good manufacturing processes
- Post-market adverse event reporting issues
Violations of Good Manufacturing Practice
- Failure to report adverse events on multiple occasions, including failing to report 16,047 complaints to the FDA
- Failure to consider reports of adverse events in their risk analysis for design of the product (migration of coils and perforation of peritoneal cavity)
- Failure to document CAPA activities
- Failure to report on post-approval studies in a timely fashion
- Failure to follow quality control procedures for ‘potential causes of non-conforming product and other quality problems’
- Failure to obtain valid state license prior to manufacture and distribution of product
- Operating facility without a license
- Failure to submit PMA supplement for new facility
- Erroneously used non-conforming materials
- Failing to use pre-sterile and post-sterile cages
- Post-market surveillance failures
- Advertising inaccuracies”
What did the FDA finally do? Not enough, according to many women’s health advocates. The agency demanded, on February 29, 2016, that Bayer include a Black Box Warning on Essure and ordered the company to conduct another safety and efficacy study of 2,000 women. The study will also examine results between patients who opted for traditional tubal ligation and those who had the Essure device implanted.
The final version of the warning now includes the following language: “…patients have experienced numerous adverse events.” The agency also warns about surgical removal of the Essure device, saying, “…if the device needs to be removed to address such an adverse event, a surgical procedure will be required.” Sadly, these surgical procedures often include total hysterectomies.
The FDA also changed the patient checklist, intended to provide patients more information so as to enable them to make the best decision for their health care. This list, formerly lengthy, confusing and not very helpful, has now been broken into individual headings. Each heading addresses a unique topic, such as possible long-term side effects, failure rates and other forms of birth control. The language used has been simplified for easier understanding and the list is now only half a page long.
Yes. Even though the Essure device is still protected by its FDA PMA approval status, over 1,000 lawsuits have been filed against Bayer. Though many of the claims in these suits have been dismissed, two federal judges held that certain claims can proceed. These claims include:
- Negligent misrepresentation
- Negligent failure to warn
- Negligent training
- A different negligent risk management count, and
- Another negligent manufacture count (XI)
These rulings also open the gates to the legal system for injured women everywhere.
Why You Need Qualified Legal Representation
The Essure litigation is complex, as is most medical device litigation. You need attorneys experienced in handling these complexities. The attorneys at Justinian and Associates have this experience and are committed to getting you the help and compensation you deserve.
We are able to navigate the maze of jurisdictional and Statue of Limitations issues you’ll face in Essure product liability litigation. What do we mean by this? At present, Essure cases have been filed in numerous jurisdictions, each with their own rules. Failure to be aware of these rule differences could mean the difference between your case being heard or dismissed.
Some differences include:
- No bright-line rule (meaning no consistently applicable rule)
- Injury only (must show actual injury)
- Injury plus causal link (must show actual injury and must prove that Essure was the cause)
- Discovery rule (When should you, the plaintiff, have become aware of your injury? This impacts how long you have to file your case.)
- Fraudulent concealment
- Need to know which will apply (state of implant, treatment, or removal)
- Preemption concerns
- Statute of limitations (SOL)
SOL Triggers (when does the clock start ticking on your ability to file a case?)
- Implant Date
- First diagnosis or treatment
- Removal or revision (first, second, third)
- FDA hearings (9/15)
- FDA announcements
- Social media posts (Note: most attorneys advise that those with active cases NOT post about Essure on social media)
Don’t Wait! The Time to Act is now!
The experienced attorneys at Justinian and Associates are standing by ready to help you get the compensation and justice you deserve. Contact us today!