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Remember that cheap ring your first love got for you, that turned your finger green? Keep that in mind.
I will start off by saying I have a deep-seated bias toward anything that the FDA lists as “safe.” Upon hearing about Essure my research came up with some startling revelations, nothing less than criminal from my perspective. As with new and innovative healthcare procedures all have their failings but Essure has been on the market since 2002. It only recently made it’s way into headlines in 2013 when a small percentage of women reported searing pain in their backs, nether regions and a host of life-altering symptoms.
Essure was created by a German company called Conceptus Inc., and was approved for usage by the FDA in 2002, after 2 and a half years of study. Recently acquired for $1.1 billion, it’s now a daughter company of Bayer Healthcare Pharmaceuticals. It has been advertised as an irreversible birth control method for women that “works with your body to create a natural barrier against pregnancy.” and “cheaper and safer than getting your tubes tied.” It’s pretty-in-pink-esque website boasts the procedure as nonsurgical, nonhormonal, “no downtime to recover,” 99% effective, FDA approved and may be available for free or minimal of charge—depending on your insurance carrier.
The procedure sounds simple enough: Small, flexible coils are placed in the fallopian tubes by way of the vagina and cervix, hence the “nonsurgical.” During the procedure you may not feel pain—if you opt for local anesthesia. The doctor may not be able to insert the device correctly, and there’s a chance the coil could pierce the fallopian tube upon insertion thus requiring additional surgery. After an successful insertion, the coils form scar tissue around them in about 3 months (on a small percentage of patients, it took up to 6 months). A second form of contraceptive should be used until the patient’s Essure Confirmation Test. A patient engaging in sexual activity, before this test is reviewed by her doctor, may be putting herself at risk for pregnancy. After the procedure, patients may or may not experience pain in back and / or pelvis, vaginal bleeding, nausea and fainting.
In the “Contact Us” section of Essure’s website, they list a headquarters office in Whippany, NJ (Morristown). The toll free number for Essure’s information center yielded no results because it was out of service. Naturally, I wasn’t surprised that the number for surgeons wishing to buy supplies and receive Essure training sessions was working without a hitch. I decided to go the long way, which was to contact Bayer Pharmaceuticals where I got a little closer to my goal. The number listed for product information on Bayer’s Pharmaceuticals directed me to a vacationing representative’s voicemail, that voicemail directed me to Rose Talarico, of the Whippany, NJ Office. Her voicemail rattled off her cell number and after calling and texting — maybe a bit persistently—she finally called me back. Talarico then informed me that she was the wrong person to contact, and said she would give representative Tara Camp my information. Three weeks later, I’m still waiting for a call back. Personally, I’m weary about any service or product that is advertised but doesn’t have a direct line to humans at the other end, to voice my concerns.
Despite some users who claim Essure is as safe and effective as advertised, there have been reports of “stabbing pain” while sitting, standing, laying down and pain during sexual activity. A woman named Betty O’Brian, living in the Atlanta metro area, claimed the pain she endured was so excruciating that she actually considered signing herself into a psychiatric ward! Later, O’Brian opted to have the Essure coils removed but was told by her doctor that the only way to remove the coils, was to have a complete hysterectomy. O’Brian claims after the hysterectomy, all of her symptoms vanished.
Most disturbing are the reports of the Essure coils falling out of the vagina, some migrating out of the fallopian tubes into the lower abdomen and puncturing internal organs. Some report depression, heavier cramp laden periods lasting up to 6 weeks and even fainting spells. Despite the horrific symptoms aforementioned the FDA still deems Essure safe to use. As a “Class III device,” Essure has “received FDA’s most stringent and rigorous review prior to marketing,” thus making it impossible for damaged parties to sue.
As to date, upwards of 750,000 women have received the Essure device worldwide. 946 plus doctors and patients have made complaints with the FDA itself. A FaceBook group called “Essure Problems” with a head count of 9,683 members encourages users to share their experiences with Essure. Even famed consumer advocate, Erin Brockovich — yeah, from the movie—got on the case, calling for the FDA to pull Essure off the market.
While some women may feel their families are complete, don’t want to have children at all or suffer from a condition where pregnancy may be fatal, I, personally, wouldn’t advise anyone to put nickel titanium metal springs in their fallopian tubes. I have no medical experience but I do know about cheap metal jewelry (nickel titanium); it turns your finger green. As a potential patient, I wouldn’t be too assured about a possible nickel allergy, perforated organs, migrating coils, metal toxicity or the myriad of painful and debilitating side effects described by users. True, 1,000 out of 750,000 users reporting severe side effects doesn’t seem like much but given the severity of the side effects, I wouldn’t risk it.
Words by Gia Shakur
