The FDA approved Essure in November 2002 as a means of permanent contraception for women. Essure is currently marketed and sold by the pharmaceutical giant, Bayer Corporation.
More than 750,000 women have undergone surgery to implant the Essure device, which until recently had been hailed as the next generation of permanent birth control. Although the device is regarded as a “permanent” implant, it is considered to be reversible, theoretically offering more flexibility than the alternative tubal ligation surgery.
Unlike tubal ligation surgery, which requires surgery and can therefore be more costly, Essure devices are implanted via catheter insertion as part of an in-office procedure. Essure has been marketed as a less expensive, easier and safer alternative to the permanent contraception/sterilization methods of the past. Additionally, Bayer advertised that Essure patients are able to resume their normal lives just a few days after the procedure and boasts that many women claim to be able to return to work (or their daily routine) the following day with mild cramping and light spotting as their only complications. Although this may be true for some women, many others have experienced considerable complications as a result of their Essure implant.
Although the complications associated with Essure are quite extensive, the following list includes the most common problems reported:
- Device migration and puncturing fallopian tubes, uterus, intestines or other organs
- Doctors complaining of the device breaking during insertion
- Reporting severe Essure side effects following the procedure, causing many to opt for a hysterectomy.
- Periods that are not normal. Some may last for weeks at a time.
- Cramping and bloating long after the procedure has been performed.
- Skin rashes- this may be due to a nickel allergy from the springs that were inserted.
- Unexplained pains near and around the stomach. Some women complain of sharp pains where the Essure devices actually are.
- Unexplained weight gain, which dieting and exercise do not help.
- Dizzy spells feeling like you are going to pass out at any moment.
- Joint, back and pelvic pain and uncomfortable intercourse that is unexplained.
- Chronic low-grade fever
- Numbness and tingling
- Hair thinning
- Extreme fatigue
- Reports to FDA of difficulty in removal of device
- Miscarriage or fetal death as a result of pregnancy occurring after Essure Implant
The FDA has received over 5093 medical device reports related to the implant; the vast majority of all reports submitted since 2013 have been submitted voluntarily, mainly by women who received Essure implants. It is estimated that just 1% to 10% of all adverse events are ever reported to the FDA, which suggests that the 5093+ reports made to date may be indicative of tens of thousands of women who may have also experienced problems related to Essure.
The medical device failure attorneys at Allen & Nolte are committed to protecting the rights of Essure victims and their families. Our team of dedicated attorneys will put their years of experience to work for you if you or a loved one have suffered health problems after Essure. Please contact us today and tell us how we can help.