Ennis & Ennis, P.A.
Essure Recall Advocates Rally in California
05/05/2015 - Women from around the country who have been harmed by Bayer's Essure birth control/sterilization device rallied today in San Fransisco to raise awareness about the Essure procedure and injuries the device can cause. Essure is advertised as a form of nonsurgical tubal ligation, but it is in fact, a painful surgical procedure. The group made their voices heard in front of the annual ACOG (American Congress of Obstetrics and Gynecology) meeting held at the Moscone Center in San Fransisco. The group hopes to meet with the ACOG board of directors to share concerns regarding the damages the device can cause as well as proper removal techniques and OBGYN patient care. The group will also rally tomorrow outside of Bayer's headquarters in Berkeley. Bayer is the manufacturer of Essure as well as two other highly controversial birth control products; Yaz birth control pills and the Mirena IUD. The group's goal for this event is to spread awareness and to demand that Bayer begin to put people over profits.
The rally is particularly relevant as troubling long-term data on women implanted with the device was released last Friday after an eight-year delay. Ongoing data was supposed to be gathered after the FDA approved Essure following a fast-track review in 2002. Since that time, the FDA has received more than 4,000 complaints of serious complications related to the device. Even more troubling is that an FDA inspector wa allegedly given record of over 16,000 complaints made to the original manufacturer, Conceptus between 2011 and 2013, when Conceptus was bought out by Bayer. It appears that over 20,000 complaints regarding the device have been completely ignored by Bayer and the FDA.
This will soon be changing. A formidable group of women called the E-Sisters have taken on Bayer and the FDA to have the device removed from the market or strong warnings added regarding the potential dangers and complications of the device. The group, which started out with a single member on a Facebook page has grown to over 17,000 strong intentioned women who are determined to be heard by Bayer.
The Essure device is a small coil placed with a special surgical instrument into a woman's fallopian tubes. The coil is made of a nickel titanium alloy and a fiber called polyethylene terephthalate (PET). This triggers an inflammatory response in the tubes causing scar tissue to develop and block the tubes preventing fertilization. However, the inflammatory process which creates the scar tissues can cause a systemic inflammatory and immune reactions as well. Additionally, many women have had severe allergic reactions to the nickel contained in the coils as well. Finally, significant problems have resulted as result of the coils migrating from the fallopian tubes and perforating the uterus or other organs, requiring many women to undergo complete hysterectomies. Problems with the device were noted from the beginning. In a safety trial that enrolled 269 women, the device was successfully implanted into only 200 of these women. In nine of them, a coil perforated the fallopian tube, was expelled or was lodged somewhere else in the body, causing injury.
Subsequent studies regarding Essure's efficacy are also troubling. A recent study by Yale University professor, Dr. Aileen Gariepy calculated that nearly 1 in 10 women will become pregnant on Essure over a ten year period, a much higher rate than with a tubal ligation. Dr. Gariepy is also troubled that Essure's long-term studies published last week did not include data on 30% of the participants. She stated, "In clinical trials, the most common reason patients are lost like this is because they had problems." The one thing that remains clear and certain regarding Essure is that the E-Sisters will continue their efforts against Bayer until the device is recalled or strong warnings place on the products.
If you or a loved one has been injured by an Essure device, contact attorney Holly Ennis at Ennis & Ennis, P.A. for a free confidential consultation.