What is Essure and How Safe and Effective is It?

What is Essure and How Safe and Effective is It?

May 15, 2018 | Pharmaceutical Litigation

Essure is a specialized form of permanent birth control. Essure is not appropriate for all women but is typically used or prescribed for women who:

  • Do not wish to have more children
  • Are looking for a permanent form of birth control
  • Need birth control sterilization without invasive surgery
  • Seeks a permanent birth control method that doesn’t use hormones

Anyone considering Essure should be aware that the procedure is not immediately effective in preventing pregnancy. For the first few months after placement of the Essure device, another form of birth control will need to be used. At three months after Essure placement, it you will need to see your doctor for a confirmation test to verify the inserts are placed correctly and that you have full protection. Using a supplemental birth control method during this time is important as pregnancy can still occur but with the Essure device in place it can be risky and dangerous to both mother and fetus if this was to occur.

 

Benefits of Essure Birth Control

  • Essure is intended to provide women with permanent birth control with a minimally invasive procedure that needs no surgery, anesthesia, or hormones.
  • Essure inserts are easy to place and can typically be done as an outpatient procedure right in the doctor’s office.
  • Essure inserts offer some of the highest levels of protection against pregnancy for most women who have the procedure done,

 

Risks Associated With Essure Birth Control

Short-term risks can include:

  • Mild to moderate pain during the placement of the inserts
  • Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort in the hours and days following the inserting of Essure

 

Long-term risks to patients reported in clinical trials include:

  • Unintended pregnancy before Essure implants are properly placed
  • Abdominal, pelvic, or back pain due to the inserts hitting major nerves
  • Perforation of the uterus or fallopian tubes during or after placement
  • Inserts that can drift into the abdominal or pelvic cavity causing serious damage

 

Other reactions that have been reported to the FDA include:

  • Headaches
  • Fatigue
  • Weight gain
  • Weight loss
  • Hair loss
  • Mood changes
  • Depression
  • Upset stomach or IBS
  • Allergy reactions
  • Joint or muscle pain
  • Nerve damage or numbness
  • Muscle weakness

It is important to remember that no form of birth control can be 100 percent effective all the time and there is always at least some chance of pregnancy occurring. Based on currently available data, the chance of someone using Essure becoming pregnant is less than 1 percent when test subjects were observed for a period of 5 years. The ease of use and the high success rate continues to make Essure one of the most popular choices for permanent birth control options.

 

Weighing the Risks and Making the Decision That is Right For You

“All pregnancies carry some risk to women and their fetus. The risks to women and their fetus if pregnancy occurs after Essure placement are unknown. While successful pregnancies with healthy deliveries have been reported with Essure devices in place, neonatal or pregnancy complications have also been reported. Also, the FDA has received reports of pregnancy losses in women who became pregnant following Essure placement. If a woman becomes pregnant with Essure, there may be a risk for the pregnancy to occur outside of the uterus (ectopic pregnancy), which may result in serious complications. The FDA will continue to monitor the safety of this device to ensure that its benefits of continue to outweigh its risks” (FDA).  With this information in hand, you can talk to your doctor about whether you are a good candidate for the Essure implants

 

Essure Lawsuits

Essure has been available in the U.S. since 2002. However, the birth control device has been linked to serious side effects and complications. Studies show that Essure can allow pregnancy and cause abdominal pain, bleeding, vaginal infection and, in severe cases, death. Initially, Essure was FDA approved and was available in stores all over the U.S. The device was approved based on how well it prevented pregnancy, how safe the procedure to implant the inserts was, and how safe the inserts continued to be for the patient after implantation. Now, the FDA is currently reconsidering their approval after a large number of patients reported that they experienced adverse complications because of Essure. So talk to an attorney about your fears, wishes, concerns, and thoughts and together you can make a decision if you’ve had any health issues that you feel may have resulted from using the Essure device.

 

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CATEGORY: Pharmaceutical Litigation

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