Patients involved in the clinical trials conducted in connection with the premarket approval application (PMA) for the Essure birth control device say that patient records were altered to show favorable results despite patient reports of problems. The Food and Drug Administration (FDA) approved Essure in 2002.
Essure is considered a permanent form of birth control, a nonsurgical alternative to the traditional tubal ligation (“tying” the tubes) procedure. Essure consists of a small pair of flexible metal coils that are inserted into the fallopian tubes to create scar tissue that blocks the tubes and prevents pregnancy. Essure can be inserted in a procedure in a doctor’s office. Essure was developed by Conceptus and is now marketed by Bayer.
When the Essure application was being considered, only one- and two-year contraceptive efficacy data was available for the device, Qmed reports. A more recent Yale study determined that women with Essure are more than four times as likely to become pregnant than those who undergo the more traditional tubal ligation.
Women have reported complications including pelvic pain, painful sex, organ perforation, device migration, metal allergies, unplanned pregnancies, and ectopic pregnancies, which can be life threatening if not detected early.
The FDA had cited Conceptus for multiple deficiencies in 483 documents, including the company’s failure to report adverse events, including two reports of bowel perforation related to insertion of the device. 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.
Kim Hudak, a patient involved in the clinical trial, says that when she obtained the medical records related to the device in 2013, the records were clearly altered. At least two other women report that their records were altered to delete reports of pain and other problems, according to Qmed. One patient reported severe pain but researchers reported that her comfort level was “excellent.” Another reported “sharp pain,” but the clinical trial documents indicate that her comfort level was “very good.” Hudak says she reported problems that 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 said the researchers coached their answers, according to Qmed.
In September 2015, in response to some 5,000 reports of complications and injuries from Essure, the FDA convened its Obstetrics and Gynecology Devices Panel to gather information from doctors and researchers and to hear women’s experiences with Essure. Members of the Facebook group Essure Problems spoke at the panel meeting, urging the FDA to pull the device from the market. The women say they were never warned about the risks. The FDA is expected to announce its decision about what action it may take in February 2016.