Patients Claim Their Records Were Altered in Premarket Approval for Essure Birth Control DeviceJan 12, 2016
According to patients involved in the clinical trials submitted in support of the premarket approval application (PMA) for the Essure birth control device, their records were altered to show favorable results although they had reported pain and other problems, according to Qmed.
Essure, a permanent form of birth control, is a nonsurgical alternative to the traditional sterilization procedure tubal ligation ("tying" the tubes). The device consists of a small pair of flexible metal coils that are inserted into the fallopian tubes to create scar tissue that blocks the tubes, preventing pregnancy. Essure is inserted in a doctor's office, and the speed and convenience of insertion has been a strong marketing point for the device. Essure was developed by Conceptus and is now marketed by Bayer.
Essure received Food and Drug Administration (FDA) approval in 2002. During the PMA process, only one- and two-year contraceptive efficacy data was available for the device, according to Qmed. But a later Yale study showed that women with Essure are more than four times as likely to become pregnant as women who undergo the traditional tubal ligation.
Since Essure has been on the market, women have reported a variety of complications including pelvic pain, painful sex, metal allergies, organ perforation, device migration, unplanned pregnancies, and ectopic pregnancies. An ectopic pregnancy, where the embryo implants outside the uterus, can be life threatening if not detected early.
Conceptus, the original Essure maker, was cited by the FDA for multiple deficiencies in 483 documents, including failure to report adverse events. The documents contain at least 41 reports of perforation—primarily of the uterus and fallopian tubes—from July 12, 2010 to December 10, 2010. As of January 6, 2011, there were 508 complaints of perforation, Qmed reports. Some of these were bowel perforations during Essure insertion.
Kim Hudak, a patient involved in the clinical trial, says her medical records, which she obtained in 2013, were clearly altered. At least two other women make similar claims, saying reports of pain and other problems had been deleted from their records, according to Qmed. One patient said she reported severe pain but researchers noted her comfort level as "excellent." Records for another woman indicate her comfort level as "very good," though she said she had reported "sharp pain." Hudak says most problems she reported never got documented. "In all, about 75% of the symptoms I mentioned to the nurses didn't make it onto the Conceptus form. When I mentioned a problem, they would say: ‘oh, we don't think that was related to the device.'" Some of the patients involved in the clinical trials say researchers coached their answers, according to Qmed.
In response to 5,000 reports of complications and injuries from Essure, the FDA convened its Obstetrics and Gynecology Devices Panel in September 2015. The panel collected information from doctors and researchers and they heard accounts from women about their experiences with Essure. Members of the Facebook group Essure Problems urged the FDA to remove Essure from the market. The women say they were never warned about Essure's risks. Next month, the FDA will announce its decision about what action it will take.