The campaign for the recall of Bayer’s Essure contraceptive device is gathering strength online among women who claim the device caused them severe pain and injuries. The women have created Facebook support pages, Twitter campaigns, and petitions, and their actions have generated considerable media attention.
The movement uses Twitter to organize women rallying to press Bayer to recall the device, MassDevice.com reports. They have also organized real-world events, including street-corner picketing.
The group has enlisted the assistance of famed consumer activist Erin Brockovich, whose organization responded to appeals for help from women who told Brockovich of injuries and complications they blame on Essure. Reports on Brockovich’s website note instances of chronic pain, colon perforations caused by movement of the device, implants that have migrated and are no longer visible on scans, pregnancies occurring despite the presence of the implants, and debilitating headaches.
The anti-Essure activists have called on Bayer to release its full clinical study reports and have reproached the U.S. Food and Drug Administration (FDA) for failing to initiate a recall of the device. But last month the FDA said its review of adverse event reports and the five-year post-approval study doesn’t support a recall over the issues the women say are associated with the implant, according to MassDevice. The agency added that Essure is 99.83% effective as a means of permanent sterilization, and that rare cases of sterilization failure, as well as certain post-treatment problems, are known issues listed in the product’s labeling.
Essure is a permanent form of birth control. Flexible inserts are implanted in the fallopian tubes. Scar tissue forms around the implants and prevent fertilization. The procedure is done on an outpatient basis and takes about 10 minutes to perform, according to Bayer’s online materials.