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Essure  Lawsuit

Essure Birth Control Lawsuit Information

 

Thousands of women who have used Essure permanent birth control implant have filed lawsuits against the device’s manufacturer, Bayer.  The device has been linked to uterine and fallopian tube perforation and other serious injuries and has been the subject of numerous FDA safety warnings.  Most recently, Bayer has announced that they will discontinue sales of Essure but may expect more lawsuits.

Essure Permanent Birth Control Lawsuit FAQ

What is Essure?


Essure is a birth control implant that was marketed as a marketed as “non-surgical permanent birth control."




How was Essure designed work?


Essure features two metal coils implanted into a woman’s fallopian tubes. This procedure could take place during a woman's regular doctor’s visit. Once the coils expanded, they would cause scar tissue to form. This scar tissue would then block the fallopian tubes and prevent pregnancy.




What are the risks of using Essure?


According to the FDA, the following risks are associated with Essure: Short-term risks to women with Essure as reported in clinical trials include:

  • Mild to moderate pain during and immediately following the Essure placement procedure.
  • Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure.
Longer-term risks to women with Essure as reported in clinical trials include:
  • Abdominal, pelvic, or back pain
  • Tear or hole (perforation) of the uterus or fallopian tubes
  • Unintended pregnancy
  • Allergy or hypersensitivity reactions
  • Essure inserts unexpectedly moved to the abdominal or pelvic cavity
  • If a patient and health care provider decide to remove Essure, another surgery may be required.
Other reactions included in medical device reports submitted to the FDA include:
  • Headache
  • Feeling tired (fatigue)
  • Weight changes
  • Hair loss
  • Mood changes, including depression
Also, It s important for women considering Essure to know that based on clinical studies, approximately 8 percent of women who undergo attempts at Essure placement are not able to rely on the deviceExternal Link Disclaimer for birth control. https://www.fda.gov/medical-devices/essure-permanent-birth-control/essure-benefits-and-risks




Can Essure be removed?


Essure, by the manufacturer's design, creates scar tissue in the fillopian tube which it also grows into and becomes intertwined with. This makes it nearly impossible to remove a Essure implant on its own. The danger of a Essure implant breaking during the removal process makes the only way to guarantee the entire Essure length is removed to have hysterectomy with bilateral salpingectomy. This is a removal of the uterus, cervix, and both fallopian tubes at once.




Has anyone gotten pregnant while using Essure?


Yes, in fact after first being implanted with a Essure device, women are told they can not rely on the device for at least 3 months. According to the FDA, roughly 8% of women who were implanted with a Essure device are never able to rely on the device to prevent pregnancy. The FDA also says that Essure is a reliable form of birth control that meets the 99% effective rate used to market the product. However, this 99% effective rate only applies to Essure devices that have been "succesfully" implanted for 5 years or more....




Was Essure FDA Approved?


Yes, in fact the FDA gave Essure pre-exemption status to sheild it from liability. However, serious questions have been raised about the testing performed on Essure and the FDA approval process. You can view recordings of the serious concerns raised at the FDA approval hearing here: https://www.youtube.com/playlist?list=PLbHvTUbmc6zxo7-sjtk9DqxgrCESBYO2X




What should I do if I have a Essure IUD?


Doctors say that if you are not experiencing problems with your device that you should not have it removed due to the risk associated with removal. However, if you have a Essure device and are experiencing symptons that could be related to Essure or begin to, you should contact your doctor immediaetly to so you can find the best medical treatment for you to. Unfortunately, thousands of women are not able to afford the procedure to have Essure removed and continue to suffer as a result of this product. If you have suffered from any of the symptoms above and have a Essure device or had a Essure device removed, call us today so we can show that this sort of disregard for the saftey of women will not be tollerated. Use any ofthe mehods for contacting us available n this site and speak to an attoney about yor claim now.





 

Essure, created by Conceptus Inc. in 1998, was first approved for sale in the U.S. in 2002. The device features two metal coils implanted into a woman’s fallopian tubes during a regular doctor’s visit. Once the coils expand, they cause scar tissue to form which blocks the tubes.

 

Bayer's decision to discontinue Essure comes just before the release of a damning documentary which focuses on Essure and the questionable FDA approval process.  The documentary also questions Bayer's practice paying millions of dollars to doctors, as "consulting fees", who frequently recommended Essure to their patients over other safer and more effective methods of permanent birth control.

 

You can see the Trailer for the documentary "The Bleeding Edge" from Netflix below as well as Essure news stories and even videos of the actual FDA approval hearing where serious concerns were raised and ignored.

 

Essure, a birth control implant, was approved in 2002 and was marketed as “non-surgical permanent birth control”.  Since that time, about 30,000 serious adverse event reports have been filed with the U.S. Food and Drug Administration for injuries caused by the device. Thousands of women who used Essure have filed lawsuits against its manufacturer, Bayer, for serious injuries caused by the device.

Over a three-year-period starting in 2002, more than 5,000 women filed complaints with the U.S. Food and Drug Administration, saying they sustained injuries or suffered unwanted pregnancies, still births and miscarriages while using the Essure device.

The number of Essure suits has skyrocketed over the last two years after U.S. regulators forced Bayer officials to beef up warnings about the device’s risks -- including bleeding, pain and organ damage -- and put sales restrictions on the product. Bayer announced July 20 that it would stop selling the implant in the U.S. at the end of the year because of declining sales. The company had already pulled the product from all other countries.

If you have experienced complications after having an Essure IUD implanted, call Langston and Lott, PLLC today to speak with an experienced attorney or complete our online case evaluation form below and let our law firm get to work for you.

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