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When Essure debuted in 2002, it was touted as an effective, efficient contraception solution. Yet, thousands of reports dating back over a decade indicate many patients experienced painful side effects and in response, many have come together to file a lawsuit.

Background

Essure involves implanting metal coils via catheter inside the fallopian tubes. A stainless steel inner tube and nickel-titanium material with polyethylene fibers then expand, causing scar tissue to develop inside and prevent fertilization.

Patients given Essure allege doctors declared the system to be safe. However, not long after its introduction, patients started experiencing:

  • Pain
  • Hemorrhaging
  • Menstrual irregularities
  • Headaches
  • Weight changes
  • Migrating devices
  • Nickel allergies
  • Cramping
  • Bloating after surgery that never subsided
  • Autoimmune diseases
  • Perforated organs
  • Pelvic pains
  • Hot flashes and night sweats
  • Brain fog
  • Itching and burning sensation

In more extreme cases, the pain and other associated symptoms caused plaintiffs to experience employment difficulties, prevented them from doing activities they enjoy or put strain on their marriages. For others, the symptoms were so unbearable they were forced to get a hysterectomy, which comes with its own series of complications, such as infections and injuries to the bowel and bladder.

As a result of these factors, the FDA started receiving adverse reports beginning in 2002, with 5,000 more sent over the years. However, after Bayer Health Care took over Essure from Conceptus, reports surged, with the FDA receiving roughly 1,000 since 2013.

Since multiple women began complaining openly online, the New York Times decided to investigate. Their researchers found that pain and other serious complications emerged in clinical trials. In one early study, 200 out of 269 women were given the device and nine women in this group had the coil perforate a fallopian tube, expel or migrate somewhere else within the body.

Another study involving 558 women had 21 reports of similar occurrences. Eight women from this group had to undergo surgery to remove Essure.

The New York Times further uncovered that the FDA initially expressed doubts about the data. Particularly, the government organization was concerned that Conceptus, a medical products manufacturer and developer, only followed up with women for a couple of years. Yet, the FDA went ahead to approve Essure, under the assumption Conceptus would track the women for another four years. However, after its approval, the developer only followed up with 171 participants from the smaller study, while 270 in total reported adverse side effects. From this group, five women had hysterectomies and one became pregnant.

By 2015, the FDA launched an investigation after women who used Essure put together a recall petition. In the document, they asserted Conceptus used fraudulent data, went against the FDA’s approval process and further violated multiple laws with its manufacturing and marketing practices.

Since patient struggles have come to light, a study published in the British Medical Journal in October 2015 discovered that women given Essure are 10 times more likely to require post-procedure surgery than those who undergo laparoscopic sterilization for birth control.

As a follow up, the FDA has since requested current manufacturer Bayer AG conduct additional studies on Essure. Furthermore, the FDA has recommended the product include a black box warning and has started providing doctors with a checklist to discuss the risks of implanted birth control with patients.

Lawsuits

In the process of coming forward, patients have started filing lawsuits in which they claim Bayer failed to warn them about the risks. While plaintiffs claim the manufacturer is guilty of negligence, Bayer AG is currently protected from product liability lawsuits; however, plaintiffs are currently seeking to remove that measure.

As Bayer continues to claim Essure is safe and 100-percent effective, it remains on the market, already used by 750,000 women across the globe. On the other hand, many who have taken it say that if they had been warned about the risks upfront, they would have opted for a hormonal contraceptive instead.