When most people think of medical malpractice, they think of a surgeon leaving a sponge in a patient during a surgical procedure. However, malpractice can occur in far more situations than that. Doctors who negligently misdiagnose a medical condition can commit malpractice, as can nurses and anesthesiologists who hurt a patient after acting negligently. Even hospitals and other healthcare facilities can commit medical malpractice if they follow policies that put patients at undue risk of harm while getting medical attention inside their doors.
Even the companies that produce medicines or medical devices can commit medical malpractice. When the equipment they create is defective, it can amount to both medical malpractice and also subject them to products liability. One example of this happening in real life is the Essure Birth Control System, which has been linked to numerous complications, serious medical conditions, and even a handful of deaths.
The Essure Birth Control System
The Essure Birth Control System is a permanent birth control device for women that is implanted into the fallopian tubes a non-surgical procedure. The device was created by the company Conceptus, who first submitted it to the Food and Drug Administration (FDA) for approval in April 2002. It was quickly approved by the FDA and entered the markets in November 2002.
The Essure System consists of a coil of stainless steel and nickel-titanium that is wrapped in synthetic polyethylene terephthalate fiber. The coil is then implanted into a patient's fallopian tubes, where the coil sits tightly and is meant to irritate the surrounding tissue. Over the course of a few months, the irritation from the implant creates scar tissue, which forms around the coil and blocks the fallopian tube, preventing eggs from descending from the fallopian tubes into the uterus. This effectively blocks the conception process, providing a permanent form of birth control.
According to Bayer, the company that purchased Essure creator Conceptus in April 2013, for $1.1 billion, the Essure Birth Control System is 99% effective. Perhaps even more enticing for women, though, the Essure System does not require the extensive “tube-tying” hysterectomy that is the traditional way of performing permanent birth control. Instead, according to Bayer, the Essure System can be implanted in a matter of minutes in the patient's doctor's office.
FDA Approval of the Essure Birth Control System
Despite the Essure Birth Control System being a unique and self-proclaimed revolutionary way of permanent birth control, the FDA approved the device for use in the U.S. in fewer than eight months.
However, perhaps because of the novelty of the Essure System, the FDA required a handful of warning labels to be used for the implants to notify doctors and their patients of the potential risks associated with the new device. Additionally, the FDA attached two important conditions to Essure's approval:
- Post-approval clinical trials needed to be conducted that would track Essure patients for five years after the received the implant, with reports filed annually. These trials needed to include a control group, and would track data of pregnancy outcome, adverse events, and samples from any extirpative surgeries that followed the implant, and
- A post-approval study to document whether physicians, who were newly-trained at implanting the Essure System, were able to successfully perform the implant on their first try.
Those post-approval reports, however, were not done. The clinical trials that the FDA had required were not published until April 24, 2015, more than twelve years after they had been ordered on an annual basis. Worse, the clinical trial that eventually was conducted was not even done properly: Many of the women who were included in the trial were not followed for the full five years, so the data from the study was inconclusive and skewed.
Complications Arise With Essure Birth Control System Implants
Despite the lack of reporting from Conceptus and, later, Bayer about the outcomes of Essure patients, it quickly became clear that the device was defective.
Soon after the device became popular, complaints from patients started to pour into the Manufacturer and User Facility Device Experience (MAUDE) database. This database collects voluntarily proffered patient experiences with medical devices, including the Essure Birth Control System. In the fourteen years between its approval in November 2002, and the end of 2016, the MAUDE database had received 14,919 reports of complications that are related to the Essure device, nearly three per day. Many reports included numerous symptoms or other medical complications, with the five most common patient problems being:
- Abdominal pain or pain in general (10,746),
- Heavier menses or menstrual irregularities (5,377),
- Headaches (4,396),
- Fatigue (3,560), and
- Weight fluctuations (3,270).
These symptoms, however, were often only the outward signs of something far more serious. Many of the MAUDE reports included descriptions of how the Essure Birth Control System had failed or proven to be defective. Among these, the top five defects were:
- An incompatibility between the Essure device and the patient, including allergies to the nickel that was in the device's metallic coil (941),
- The Essure implant migrating out of the fallopian tubes (482),
- The Essure device not operating the way it was supposed to, including allowing eggs to descend from the ovaries, through the fallopian tubes, and into the uterus and allowing conception (301),
- The Essure device breaking while inside the fallopian tubes (259), and
- Incorrectly positioned Essure devices (133).
Some of these device malfunctions are quite serious and create further medical conditions that, in some cases, are life-threatening.
Nickel Allergies from Corroding Essure Birth Control Systems
The leading problem from the MAUDE database was a “patient/device incompatibility.” These included numerous instances of the nickel in the Essure device triggering an allergic reaction to the patient inside their fallopian tubes. Allergic reactions to nickel can cause dermatitis, which is not always a severe symptom when it is on someone's skin. When it is internal in the patient's fallopian tubes, however, it can be very painful and debilitating.
To make matters worse, the potential for nickel allergies had been something that the FDA had suspected would happen during its brief approval process. They had even required Essure devices to have a warning label on them, detailing the possibility of a serious nickel allergy to alert patients and to signal to doctors to perform an allergy check before implanting one of the devices in a patient. However, Conceptus had managed to convince the FDA to retract the warning label from Essure's instructions back in 2011.
The potential for a nickel allergy in some patients led to the rapid onset of some serious health problems. In one study, conducted by a group of dermatologists, dermatitis from the Essure device was found to come from corrosion of the metallic coil implanted in the fallopian tubes. This corrosion began occurring very quickly, in many cases within a few days of the implant.
Corrosion Causes Other Health Problems
Dermatitis, unfortunately, was not the only medical condition linked to the corroding metal in the Essure Birth Control System. Other infections, like the group A strep infection, were also linked to corrosion of the Essure System soon after it was implanted.
Migrating Essure Devices Cause Serious Health Conditions
In addition to corroding rapidly, the Essure Birth Control System has shown a propensity to “migrate” out of the patient's fallopian tubes and into other areas of their body. There have been numerous reports of Essure devices migrating from the fallopian tubes and into a patient's abdomen. This migration comes with the high possibility of internal perforation injuries along the way, especially to the patient's reproductive organs, and requires follow-up surgery to remove the wandering device.
Essure Devices Break, Causing Health Issues
One of the most reported issues with the Essure Birth Control System was that the metallic coil had a tendency to break while implanted inside a patient's fallopian tubes. If broken, the coil could then puncture the walls of the fallopian tubes and cause serious injuries and lots of pain.
Improperly Placed Essure Devices Fail
Precisely because the Essure Birth Control System can be done in a non-surgical setting, the chances of it being improperly placed during the procedure are alarmingly high. However, if they are improperly placed, Essure Birth Control devices stand a higher chance of migrating or failing to prevent conception.
The FDA was aware of this issue during its approval process, and so required creator Conceptus to do post-approval work to train and instruct doctors on how to properly implant the device in a patient's fallopian tubes. However, reports from after the device's explosion in popularity showed that the training that was provided was far from adequate.
Criticisms of Essure Birth Control System
Because of the wide variety of problems that the Essure device has had in its years on the market, and because of the number of women who have been hurt by these issues, the Essure Birth Control System has been widely criticized.
One study that was published in the British Medical Journal in October 2015, found that, when compared to women who had a traditional laparoscopic hysterectomy, patients who had the Essure device implanted were ten times as likely to need a revision surgery, but still had the same chance of an accidental pregnancy.
Other investigations found similar problems. An investigation by National Public Radio chronicled the numerous medical conditions that spawned from the Essure implant, while the New York Times found that the FDA had received over 4,000 reports of serious complications from the Essure device.
The criticisms called the FDA to review the Essure device with an advisory committee in September 2015. The committee investigated the numerous problems that the Essure Birth Control System had created with patients and ended up approving a prominent black-box warning on Essure's packaging, to warn potential patients and their doctors of the issues that past patients have had with the product.
Refusal to Recall Essure Device Leads Congress to Threaten Action
Despite the medical problems that the Essure device has caused for a significant portion of its patients, Bayer, the current owner of the device, has refused to issue a recall, and has claimed that it cannot be sued for compensatory damages in a medical malpractice or products liability claim because they bought the Essure device after its approval by the FDA. This has led Washington politicians to introduce a bill that would prevent medical device manufacturers, including Bayer, from claiming that federal approval of their device preempted state law claims for compensation.
Essure Faces Litigation in Numerous States for Medical Conditions It Has Caused
Numerous lawsuits have been filed against Bayer, the current owner of the Essure Birth Control System. These cases are all individual cases, not class actions, that have been consolidated into a small handful of courts, including the federal district court in Philadelphia, to make them easier to manage.
However, Bayer's claim that it should be protected from lawsuits because of the FDA's prior approval is slowing the progress down to a crawl. Bayer's argument, called “federal preemption,” is that it would be unfair to Bayer to lose money in a lawsuit after they relied on the FDA's approval of the Essure device when they decided to buy it from its creator company, Conceptus.
Maryland Medical Malpractice Attorneys at Gilman & Bedigian
Between Bayer's culpability and the losses of the victims of the Essure Birth Control System, it seems clear who should have to bear the risk of loss. That is why the personal injury and medical malpractice attorneys at Gilman & Bedigian strive to represent victims of the Essure device both in and out of court.
If you or a loved one has had an Essure device implanted and have faced the pain, suffering, and medical complications that so many others have had to go through, you need a lawyer. Reach out to Gilman & Bedigian by contacting them online or calling their law office at (800) 529-6162 for a free consultation.