Essure is a kind of permanent, less-invasive sterilization procedure that women who want to avoid pregnancy have the option to use. The device is a coil designed to cause fibrosis and block the fallopian tubes to prevent fertilization. Many women who decided to use this option wanted to have a less invasive alternative to hysterectomy, or a complete removal of the uterus. However, thousands of women have complained of adverse side effects resulting from the device.
According to Essure’s Physician Training Manual, in its clinical trials, Essure had a perforation rate of 3.4% (meaning Essure poked a hole through fallopian tubes in some cases) and a 0.5% expulsion rate. Only 9 out of 14 patients underwent a successful second placement after the expulsion, which happens when the body rejects a foreign body. However, later the manual contradicts itself by saying perforation and adverse events associated with surgery were not observed in clinical trials.
Essure also has a relatively high failure rate. While one study indicated a 99.74% effectiveness rating, one study showed a failure rate close to 11%. Part of the reason it fails is perforation. Outside clinical settings, the perforation rate increased to 14% in the United States and 5% in other countries. Damage caused by perforation could also require women to undergo a hysterectomy if there is no way to repair the injury.
As of May 2015, the U.S. Food and Drug Administration (FDA) received 4,000 reports of serious complications related to Essure, including some of the following:
- Severe back pain
- Severe pelvic pain
- Heavy, prolonged menstrual periods
- Perforation that pierced fallopian tubes
- The coil lodging in other organs
A citizens’ petition to the FDA stated an inspector was given records of 16,047 complaints made to the original manufacturer of Essure, Conceptus, between 2011 and 2013. However, both the FDA and Bayer says Essure’s benefits outweigh its risks.
There are about 750,000 Essure devices in use worldwide. If you have been affected negatively by one of these products, don’t hesitate to call us. Kaiser Gornick, LLP has more than 50 years of combined legal experience to offer your case. We have been representing individuals who have been harmed by defective medical devices of years. Our experienced San Francisco product liability attorneys have helped people obtain hundreds of millions of dollars in settlements for their injuries. We also have a proven track record of providing the highest level of client service. Let us see what we can do for you.
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