Essure Problems Subject Thousands Of Women To Excruciating Pain

Essure Problems Subject Thousands Of Women To Excruciating Pain 2016-11-23T09:35:57+00:00

silhouette of mourning womanEssure sterilization implants are commonly presented to women seeking permanent birth control as an easier, supposedly non-surgical alternative to getting their tubes tied. The promise of effortless, lifelong contraception through a quick outpatient procedure appeals to many patients, and about 750,000 women worldwide have elected to receive the implants so far.

But according to thousands of Essure users, instead of simplifying life as promised, the implants have turned their lives into a veritable nightmare with a host of severe, health-destroying side effects.

Adverse Effects Linked To Essure

Based on data from clinical trials and complaints filed through MedWatch, the FDA’s official reporting system, as well as those from patient comments in traditional and social media, Essure has been linked to over 120 side effects.  Some of the most frequently-cited problems include:

  • Abdominal and pelvic pain that is often described as intense and /or persistent
  • Chronic headaches
  • Fatigue
  • Hypersensitivity reactions that may be caused by metal allergies
  • Heavy or otherwise abnormal bleeding

You can find a full list of recorded side effect symptoms for Essure on the official website for Essure Problems, a major grassroots victim advocate group .  Note that the side effects are so numerous that they can grouped within larger categories, such as gynecological problems, psychological effects, gastrointestinal issues, etc.

Were Complaints From Study Participants Ignored, Altered?

doctor fills out Essure side effects formDespite the large volume of adverse reports regarding Essure–at least 10,000 so far, according to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database–as well as constant online complaints about Essure posted by harmed patients, Bayer continues to advertise Essure as a safe, “worry-free” device.  Advertising materials often mention high levels of satisfaction among patients from clinical trials.

However, participants from the early clinical trials that Bayer used as part of Essure’s application for Pre-Market Approval are saying that their complaints were either altered or went unrecorded by the Bayer-sponsored researchers. Kim Hudak, a clinical trial participant who later provided sworn testimony indicating that her follow-up interviews regarding her experience with Essure were manipulated, says that her complaints of pain and other side effects were dismissed as “unrelated” to the device.

Hudak says even the instruction and wording on provided questionnaires seemed to be designed to steer patients towards favorable answers. For example, she was told that as long as the device was preventing her from getting pregnant, she should give it “excellent” marks on her questionnaires. Other participants report seeing their questionnaires physically altered, with negative responses “crossed out.”

Though the FDA declared that it hasn’t yet seen solid evidence of systematic tampering of records, the matter is still under investigation.

Complications Patients May Experience

Some examples of the shocking complications related to device failure or procedural errors that patients have reported include:

Unplanned pregnancy. Though Bayer, Essure’s current manufacturer, advertises an efficacy rate of over 99%, recent studies suggest otherwise. For instance, a 2014 study conducted by Yale and UC Davis found that Essure users were more than 3 times more likely to get pregnant than women who were sterilized via tubal ligation, with a pregnancy incidence of almost 10%.

Worse yet, patients who become pregnant while implanted with Essure are likely to have an ectopic pregnancy, which is when a fertilized egg stays in the fallopian tubes rather than moving to the uterus. Ectopic pregnancies are medical emergencies that usually must be treated with surgery. Though the growing egg cannot be nourished properly outside the uterus, it can cause the fallopian tubes to stretch and eventually rupture, causing potentially-deadly bleeding. Treatment typically involves retrieving the egg and repairing or removing the fallopian tubes.

Patient-device incompatibility. Sometimes patients have unexplained allergic reactions to Essure implants, such as severe rashes or hair loss, that may be due to metal allergies or some other form of hypersensitivity to the device. Some have even developed chronic autoimmune diseases such as eczema, celiac disease or lupus after receiving the implants. Bayer was heavily criticized by medical experts during the the FDA’s recent Essure panel review meeting for not conducting research on metal allergies, especially considering that metal sensitivity is relatively common in women.

Incorrect placement. Doctors can rarely achieve a clear visual of the implantation site, leading to many misplaced implants, which necessitates re-operation. Even doctors who routinely perform Essure implantation can still find the placement procedure difficult and unreliable. For example, Dr. Charles Monteith, a former Planned Parenthood director who placed over 200 Essure devices, told the FDA that he greatly disliked the inconsistency of the procedure, saying that he was “never sure” it would go as planned despite extensive experience with it.

Device migration. If the device is poorly positioned or ill-fitting, or if the metal is somehow damaged or weakened, the implants can fall out of the fallopian tubes and migrate through the pelvic cavity. As they are designed to cause inflammation at the implantation site, the implants can cause widespread internal damage after migration, including organ adhesions and uncontrolled scarring.

Uterine or intestinal perforation. The sharp ends of Essure coils can pierce through organs or other internal structures, whether during the placement procedure or after device migration. The damage caused can require extensive and / or repeated surgeries to fix. Often, patients don’t find out about a perforation until they go to their Essure follow-up appointment (a radiologic test, performed about 3 months post-procedure, for confirming that the fallopian tubes are closed off). Other patients may remain unaware that their implants are puncturing organs until they undergo Essure removal surgery or hysterectomy to treat pain or other symptoms.

Death. According to the FDA, at least 9 Essure-related deaths have been reported so far, including 3 adult deaths attributed to placement or removal surgery complications, a case of suicide, and 5 fetal deaths from Essure pregnancies.

However, the FDA’s fetal death count may be vastly underestimated. In mid-February 2016, a private data analyst named Madris Tomes announced that after analyzing Essure adverse reports from the database on the FDA website, she uncovered a total of 303 fetal deaths. She believes she was able to find a greater number of deaths in her analysis because she included a wider selection of relevant search terms—rather than only looking for “deaths,” she included terms such as “stillbirth” and “stillborn.”

Removal Can Be Hard To Obtain — And For Some, It’s Too Late

Patients who suffer intensely from side effects and need to have the implants removed promptly may be forced to go as far as undergoing hysterectomy, unless they happen to live near one of the few doctors trained in proper removal of Essure coils or have the resources to travel for the operation. Also, patients may not be able to afford removal surgery as it’s often not covered by insurance even in cases where the original placement procedure was. During the September 2015 FDA panel meeting regarding Essure effectiveness and safety, multiple speakers showed dismay and disapproval at the glaring lack of available options for women to have their implants safely removed. As patient advocate Cynthia Chauhan puts it, “[I]f you do not have access to someone who can remove successfully, you should not be implanting.”

Furthermore, though for some patients adverse Essure effects are alleviated after device removal or hysterectomy, for others, the nightmare continues. Especially because of the scarring response that the coils are designed to elicit, it can be next to impossible to retrieve lost coils or broken fragments, and these objects can continue to exert deleterious effects on the patient. For women who develop chronic autoimmune disorders from Essure, life may never return to normal.

Victims Of Side Effects Unite Against Bayer In “Essure Problems”

After struggling to get doctors to take her complaints of joint / pelvic pain and heavy bleeding seriously, Angie Firmalino from Tannersville, NY, started the Essure Problems Facebook group in 2011. Implanted in 2009, Firmalino eventually underwent a hysterectomy in 2014 after discovering that the Essure coils had migrated and became embedded in her uterus. She originally founded Essure Problems to warn her loved ones of the device’s potential dangers, but with the help of other impassioned survivors, the group evolved into both a large, vital support network for victims and a powerful grassroots movement for an Essure ban / recall.

Today, the group has an active, steadily-growing membership numbering over 27,000 and has achieved significant strides in raising public awareness of Essure’s risks through numerous print and television interviews, Essure-related petitions, and correspondence with government officials.

Women Share Their Tragic Stories

The Essure Problems administrators describe reading new posts and messages daily from women suffering through adverse Essure effects, and a growing number of these stories are coming to national attention through news outlets:

Gabby Avina. A gynecological nurse, Avina served as a participant in early Essure clinical trials and even acted as a spokesperson for Essure’s original designer/manufacturer, Conceptus, Inc. during speaking engagements and on the product website. But after being implanted in 2000, she developed 5 different autoimmune diseases over a period of 12 years, including:

  • Hashimoto’s thyroid disease. Avina was diagnosed with this disease, in which the immune system mistakenly attacks healthy thyroid tissue, in April 2001—just 6 months after implantation.
  • Immunologic thrombocytopenic purpura. A disorder characterized by excessive bruising / bleeding due to immune cells destroying platelets (blood cells necessary for clotting). Avina had the acute onset form of the disease and needed several blood transfusions. She hospitalized for almost 2 weeks in 2003, and was later given chemotherapy in order to kill off the malfunctioning antibodies, eventually going into remission in 2005.
  • Celiac disease. In this disease, any gluten-containing foods ingested causes damage to the lining of the small intestine, resulting in pain and malnutrition from poor absorption. Avina was diagnosed in 2007.
  • Myasthenia gravis. In 2008, Avina found herself starting to “lose control over [her] ability to chew and swallow” due to this disorder, which can be caused by antibodies blocking receptors necessary for muscle contraction.  Again, she needed chemotherapy treatments, as progression of the disease can result in death if it reaches the point where the lung muscles become too weak to function.

These disorders also caused Avina to suffer from extreme fatigue and clinical depression, with disastrous effects on her career, marriage, and family life.

Amanda Dykeman. After her placement procedure in 2010, Dykeman suffered from a variety of distressing symptoms, such as pain (in her joints, abdomen, and back, as well as from migraines), chronic fatigue, bloating severe enough that she appeared pregnant, digestive problems, hair loss, and dental issues. She eventually underwent hysterectomy in 2013; a surgical report revealed cervical inflammation and a coil that had migrated out of her left fallopian tube.

Some of Dykeman’s symptoms have persisted after her hysterectomy, which could be due to internal damage from the migrated coil. Her doctor said that her abdomen was populated with “adhesions that attach [her] organs together with bands of scar tissue, making it hard for [her] food to digest.”

Sarah Payne. During her implantation in 2010, Payne was shocked at how painful the procedure was, describing it as “the most excruciating pain [she’d] ever felt.” Afterwards, the pelvic pain continued, and other adverse symptoms such as hair loss and migraines soon followed. Payne now believes that Essure is causing her to experience early menopause, as she suffers from hot flashes and excessive nighttime sweating, and has been advised to undergo hysterectomy.

Carrie Hirmer. In less than 2 weeks after receiving Essure in 2013, Hirmer went back to her doctor for intense pain and discovered that her left fallopian tube was infected due to an abscess that was “the size of a softball and…leaking infection into [her] abdomen.” She was hospitalized for 4 days and eventually obtained a hysterectomy, but some side effects have persisted and left her disabled. Hirmer laments that because of Essure, she “went from running a successful business and being in grad school to becoming permanently disabled in less than a year.”

Side Effects May Cause Device To Be Pulled From The Market

After constant pressure from the public and activist groups like Essure Problems, the FDA initiated a major review on the safety and efficacy of Essure in 2015, which will conclude by the end of February 2016. Many victims hope that the FDA will recall or at least severely restrict sales of the device in order to protect more women from being harmed.

Yet even if the FDA merely issues warnings instead of a recall, Congress may force the agency to pull Essure from the market by enacting the “E-Free Act,” a bill proposal calling for the retraction of its approval. Though it’s still early in the legislative process for the “E-Free Act,” which was introduced in November 2015 by Pennsylvania Representative Mike Fitzpatrick, the proposed bipartisan bill is co-sponsored by 5 other Congresspeople and has already inspired hundreds of citizen support letters.