On November 4th, 2002 the FDA approved Essure as a means of permanent contraception for women. Although originally designed and manufactured by Conceptus, Essure has since been acquired by the pharmaceutical giant, Bayer Corporation.
Since 2002, it is estimated that 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 also considered to be reversible, theoretically offering more flexibility than the alternative tubal ligation surgery.
Unlike tubal ligation, which requires surgery and can therefore be more costly, Essure devices are implanted via catheter insertion as part of an in-office procedure that does not require the use of anesthesia or incisions. The functionality of the device relies upon the formation of scar tissue around the implant which acts as a blockade, thus preventing insemination. Because of these fundamental differences, Essure has been marketed as a less expensive, easier and safer alternative to the permanent contraception/sterilization methods of the past. Additionally, Essure often advertises that 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. To complicate things further, many doctors are forced to recommend extreme measures to circumvent the issues caused by Essure, including full hysterectomies in women who did not require nor desire such a surgery before 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 of fallopian tubes, uterus, intestines or other organs.
- Device breaking during insertion.
- Severe side effects following the Essure procedure, causing many to opt for a hysterectomy.
- Abnormal menstrual cycles, for example some may last for weeks at a time.
- Cramping and bloating long after the procedure has been performed.
- Skin rashes, potentially due to a nickel allergy from the inserted springs.
- Unexplained pains near and around the stomach. Some women complain of sharp pains where the Essure devices are located.
- Unexplained weight gain, not helped by dieting or exercise.
- Dizzy spells or feelings of faintness.
- Joint, back and pelvic pain and uncomfortable intercourse that is unexplained.
- Chronic low-grade fever
- Numbness and tingling
- Hair thinning
- Extreme fatigue
- Difficulty removing the device.
- Miscarriage or fetal death as a result of pregnancy occurring after Essure Implant.
Since its approval in 2002, the FDA has received over 5093 medical device reports related to the implant 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.
Essure Lawsuit Lawyers
Wexler Wallace LLP is committed to pursuing claims against the manufacturer of this harmful medical device, and will be providing case evaluations for women who may have been injured as a result of their Essure implant. All consultations are free and completely confidential. Our experienced attorneys have successfully and aggressively pursued countless medical device cases in the past, and have succeeded in obtaining substantial compensation for our clients. If you or someone you know has experienced any of the complications listed above as a result of Essure, you may be eligible to pursue a claim. Please contact us or complete our Online Form as soon as possible. Wexler Wallace also welcomes inquiries from other counsel considering referring a case with respect to Essure injuries.