Sterilization Implant Essure Side Effects
These side effects have led to pain and serious complications in some cases even fatalities leading some to question whether essure should even be on the market at all.
Sterilization implant essure side effects. Since then the device has had a tumultuous history. The procedure is an alternative to surgical sterilization. The fda concluded its essure investigation in february 2016 with plans to issue an urgent black box warning and a standard checklist to help. Food and drug administration approved essure permanent birth control in 2002.
Reported side effects range from mild pelvic pain to death. In response to an increasing number of complaints about essure side effects and complications the fda initiated a thorough safety review of the high risk sterilization device in 2015. Potential disadvantages of the system include the fact that not all women will achieve successful placement of both inserts. Essure is a permanently implanted birth control device for women female sterilization.
As women spoke out about their essure complications the magnitude of the problem became increasingly clear. Side effects during or immediately following the procedure may include mild to moderate cramping nausea vomiting dizziness light headedness bleeding and or. It was reported that 8 of the population with the implant were not able to rely on the device for birth control. Severe side effects led some women to file essure lawsuits against the device s maker bayer.
The essure device has a reported effectiveness of 99 8. Speak with your doctor or other care provider about any safety concerns you may have about the device. It warns that some side effects are serious and may require surgery. Between november 2002 and december 2019 the fda received 47 856 adverse event reports for essure.
Thousands of women in the united states and other countries have reported serious side effects. Other studies show that a successful essure implant can reduce the risk of pregnancy to less than 1. This is an exciting development for women looking for an alternative to surgical sterilization but the side effects of using essure have so far harmed thousands of women. Health side effects from essure sterilization.
If you already have the device in place and don t have any side effects you can continue to rely on essure to prevent pregnancy. Essure side effects created legal problems for bayer. Conceptus originally manufactured the female sterilization implant and bayer bought the company in 2013. The essure implant is a permanent form of birth control where metal coils are inserted into the fallopian tubes causing scar tissue to develop that is supposed to prevent sperm from fertilizing the eggs.
The fda placed a black box warning on essure in november 2016. The essure facebook group boosted media coverage of device side effects.