The FDA’s analysis also revealed several frequently-cited device complications including:
- Patient-device incompatibility such as metal allergies (2016)
- Migrated implants or implant fragments (854)
- Device operation differing from patient expectations (490)
- Breaking of device (429)
- Device removal difficulties (280)
- Incorrectly-placed devices (199)
- Challenges in device insertion (187)
Though these represent the most frequently-mentioned problems, victims have described over 100 additional Essure-related adverse effects and complications. The organizers of Essure Problems, a grassroots anti-Essure movement and victim support group, have compiled a comprehensive list of Essure side effects on their official website.
Essure Complaints On The Rise
In recent years, the volume of adverse Essure reports has increased dramatically. Over 4,000 were submitted in only 2 years (between October 2013 and June 2015) and the FDA is constantly receiving new complaints through its MedWatch Program, which is open to manufacturers, physicians, and patients who witness or experience any problems with Essure.
Furthermore, adverse event reports for medical devices are currently only mandatory for manufacturers. If physicians were also required to inform the FDA whenever they encounter Essure-related problems—which may come to pass if the recently proposed Medical Device Guardians Act is enacted—it’s likely that the rate of Essure complaints submitted would climb even higher.
Essure Death Count Higher Than Previous Estimate
Shockingly, some reports reveal that Essure complications can prove fatal. The FDA has acknowledged at least 9 Essure-related deaths so far, including adult deaths from:
- Post-implantation infection
- Accidental puncturing of the uterus during placement
- An air embolism that occurred during Essure removal surgery
- Suicide of a patient suffering from Essure side effects
The other five fatalities involved fetal deaths, according to the FDA. However, a recent analysis of adverse Essure reports suggests that this number is a gross underestimate.
Madris Tomes, founder and head of the data analysis company Device Events, performed an independent analysis that uncovered almost 300 more fetal deaths while evaluating the FDA’s database of MedWatch reports. Pivotal to Tomes’s analysis strategy was her use of a wider-than-usual variety of keywords—such as including terms like “stillborn and “miscarriage”—rather than just searching for “deaths.”
Tragic Impact On Patient Well-Being
Sadly, in some cases, health problems believed to be caused by Essure become severe enough to affect nearly every aspect of a patient’s existence. Many women have posted on Essure Problems and other victim support groups, describing how Essure side effects virtually ruined their lives:
- Career problems. Severe fatigue and constant pain, two of the top complaints in reports to the FDA, can drastically limit a woman’s career and earning potential. Such debilitating side effects make it difficult to concentrate, carry out normal workday tasks, handle social interactions, or even to commute a reasonable distance for work.
- Medical expenses. Naturally, patients suffering side effects go to their doctors to try and identify the causes of their health concerns. Diagnosis often requires a series of costly tests and examinations. Patients may also need medication for pain and other treatments, which only adds to the expense.
- Long-term or permanent health conditions. Some women believe that Essure caused them to develop chronic illnesses, particularly autoimmune disorders. Bayer representatives have even admitted that this can occur, while dismissing the incidence rate as insignificant – even though the large total number of Essure users still suggests hundreds of women could have experienced these debilitating effects.
- Impact on mental health. Victim advocacy groups point out that Essure’s influence can extend beyond physical deterioration and financial loss. Especially alarming is how pressure and strain from other adverse Essure effects may cause patients to fall into depression and even start to have suicidal thoughts.
- Relationship strain. Pain and suffering from side effects can make it extremely challenging for victims to care for their children and offer companionship to their spouses, extended family, and friends. Tragically, loved ones may not always be able to truly comprehend the weight of hardships endured by victims of Essure. This can lead to misunderstanding and unrest that tears families apart and causes other significant relationships to crumble, leaving the Essure patient even more distressed.
Victims Step Forward To Share Their Stories
Tired of being dismissed by Bayer representatives and members of the medical community who claim that the ”low” percentage of patients suffering severe Essure side effects doesn’t justify banning the device entirely, many Essure victims are bravely sharing their heart-breaking personal experiences in news interviews, press conferences, and other prominent media events.
Angie Firmalino. Firmalino, one of the founding members of Essure Problems, received Essure implantation in 2009. She suffered from “severe pain and nonstop bleeding” for years before her doctors finally honed in on the likely cause—Essure implants that had moved from their proper place in her fallopian tubes to her uterus and broke. To remove the device and its fragments, she needed to undergo hysterectomy and several additional surgeries. Unfortunately, it’s all too common for women seeking Essure removal to undergo hysterectomy rather than removal of just the implants, due to the widespread lack of access to removal specialists.
Amanda Dykeman. Dykeman says Essure “permanently ruined [her] body inside and out.” After implantation, she experienced an onslaught of devastating symptoms, including painful migraines, joint aches, bloating so extreme that she looked pregnant, hair thinning, tooth erosion, fatigue and loss of concentration. Though she had Essure removed via hysterectomy years ago, the surgeon’s report noted that one of the implants had migrated, which she believes caused her to suffer lasting internal damage. Indeed, after further examination, her doctor informed her that some of the organs in her abdomen had melded together “bands of scar tissue,” causing her recurring digestive issues.
Carrie Hirmer. Shocked by the level of pain she experienced within only two weeks of getting implanted with Essure, Hirmer returned to her doctor for an early checkup. It turns out that her pain most likely stemmed from an abscess “the size of a softball” that had spread infection from her left fallopian tube all the way into her abdomen. She had to be hospitalized for treatment and later decided to have a hysterectomy. Sadly, not all of her side effects were alleviated after her operation, and Hirmer says that Essure brought her from being a successful business owner and graduate student to “permanently disabled in less than a year.”
Gabriella Avina. A registered nurse who served as a well-known spokesperson for Essure around the time of the device’s launch, Avina began experiencing adverse effects in less than 6 months after implantation. Over the next 12 years, she would be diagnosed with five autoimmune diseases she believes were caused by Essure. These include acute onset of immunologic thrombocytopenic purpura (where cells responsible for blood clotting are attacked and destroyed, resulting in excessive bruising and blood loss) and myasthenia gravis (where antibody activity interferes with smooth muscle function) — potentially life-threatening conditions that required hospitalization and chemotherapy treatments.
Did Essure Slide Past The FDA’s Usual Scrutiny?
The FDA is responsible for ensuring that any medical devices available for sale to the public pose no unreasonable health risks for potential users. How did Essure, with all its reported side effects, manage to gain the FDA’s approval? Let’s look closer into the FDA’s approval process for devices like Essure.
The FDA uses 3 classification groups for medical devices that are numbered according to relative risk, from Class I, which contains the lowest risk devices (such as dental floss, according to the FDA website) to Class III, which contains devices that sustain or pose a significant danger to human life. Essure, as a medical device that functions by being implanted in the body, is categorized in “high risk” Class III.
Naturally, Class III devices are subject to the strictest regulations , especially concerning their initial market release to the public. New Class III devices must go through a strict “Pre-Market Approval” (PMA) process in order to be deemed fit for the market. The approval application requires manufacturers to perform rigorous safety testing, clinical trials, and other medical studies to help demonstrate that their new device is reasonably safe for consumers.
An Exception To The PMA Process
However, Essure was granted an “Investigational Device Exemption” (IDE) which allows for less rigorous data to be submitted. IDEs are supposed to be used when a new device seems likely to become a medical breakthrough that may help save lives or have some other considerable benefit for the public. Because Essure was presented as a “non-surgical” form of sterilization that many women might consider to be a preferable alternative to tubal ligation, the FDA decided to speed up its approval with an IDE.
Essure Approved On Biased Or Altered Studies?
Some critics believe that the clinical data that the FDA used as justification for approving Essure was unreliable, either because of poor study design, researcher bias, or even from outright tampering with data.
In the FDA’s 2015 panel meeting for Essure safety concerns, the early Essure clinical trials, which produced resoundingly positive results that clash with the later flood of adverse postmarket reports, were a major topic of discussion. Some experts denounced the lack of randomized, controlled studies, which are generally acknowledged as the “gold standard” in medical research. Others pointed out that Essure’s clinical trials were sponsored by the manufacturer, an obvious source of possible bias.
The FDA is also in the process of investigating accusations from a citizen’s petition signed by over 2,000 patients that say medical records and clinical trial surveys were modified in order to depict Essure in the best possible light. Though the FDA has stated that it hasn’t found solid evidence for “systematic tampering” so far, some clinical trial participants have come forward to describe possible incidences of researchers attempting to manipulate data.
For example, early clinical trial participant Kim Hudak relates in an interview how she was “heavily coached” to fill out questionnaires in a way that reflected positively on Essure despite the fact that she was experiencing various health problems after being implanted with the device. Later, she says, she found questionnaires from her file in which doctors had apparently “crossed out” her original responses and “circled new answers.”
Recent Study: Essure Approved On “Flawed Data”
Whether or not the Essure clinical trial accusations are true, some researchers suspect that the FDA isn’t evaluating gynecological medical devices for safety / efficacy as closely as one would hope.
A study conducted by a team of researchers from Northwestern University, published in Obstetrics and Gynecology in May 2016, suggest that the FDA may be approving a significant number of Class III devices based on “flawed data.”
Looking at the regulatory history for 18 devices released between 2000 and 2015, the study authors found that
- 22 percent (4 devices) were approved despite clinical trials showing limited efficacy
- 33 percent (6 devices) weren’t required to be monitored through post-market studies
- 3 devices were approved but later recalled by the FDA
- One recalled device had not received a majority vote of recommendations for approval by the FDA’s advisory panel committee
- The other 2 recalled devices had not even gone through a panel review
Essure was one of the devices examined, with the authors expressing dismay at how the “permanent” device was approved based on “short term evidence” and limited postmarket follow-up. In discussing their results, the researchers underline the need to enforce more stringent, consistent requirements for the use of randomized, controlled studies and sufficient postmarket surveillance, rather than the “case-by-case” strategy uncovered in the study. The senior author, Dr. Steve Xu, questions the logic behind regulations that hold drugs to higher standards than high-risk devices.
Victims Of Essure Side Effects Are Filing Lawsuits
As we’ve seen, in contrast to the overwhelmingly positive results from Essure’s early clinical trials, thousands of women report experiencing serious, sometimes life-threatening adverse effects from the device. And though the FDA’s approval process may be in dire need of change, many patients who say they were harmed by Essure believe that Bayer, Essure’s manufacturer, is the one largely responsible for their injuries.
Hundreds of women across the country have already filed Essure lawsuits, leveling accusations against Bayer of misleading marketing and failure to give patients proper risk warnings. These plaintiffs claim that if they had been accurately informed about common Essure side effects earlier, they would have never gotten the implants in the first place and would have likely avoided deleterious effects on their health and well-being.
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