Bayer Healthcare (OTC:BAYRY) last week cited a study published in the Journal of Minimally Invasive Gynecology with 5-year results for its Essure female sterilization procedure, which has become a lightning rod for patient activists since the FDA approved it 13 years ago.
Bayer said the study, a prospective 5-year follow-up of the initial 364-patient cohort from its Phase III trial for Essure, showed no pregnancies after 5 years and that the Essure inserts were "generally well tolerated." The Phase III trial enrolled fertile women ages 21 to 40 in monogamous relationships who were willing to use a temporary contraceptive for the 1st 3 months after Essure implantation, Bayer said.
Essure is part of the product portfolio Bayer acquired in the $1.1 billion buyout of Conceptus in 2013. Conceptus won FDA approval for Essure in 2002 under an expedited pre-market approval process. The device is a permanent form of birth control, comprised of flexible inserts that are implanted in the fallopian tubes where scar tissue forms around them. Essure is the only permanent contraceptive option that requires no incisions, the FDA has said, and the device contains no hormones and can be placed without need for anesthesia.
"The results of this study, which are consistent with other published literature on Essure, document the extended 5-year effectiveness, safety, and tolerability of Essure inserts," trial investigator Dr. John Nichols Jr., of the Piedmont Reproductive Endocrinology Group in Greenville, S.C., said in prepared remarks.
Bayer said there were 3 serious adverse events there were "possibly related" to Essure in the trial, including a woman with irregular menstrual bleeding, another with lower abdominal pain and very heavy periods and a 3rd with continuous bleeding. The latter 2 women ended up having hysterectomies, the company said.
Pelvic pain was reported in no more than 7% of study participants at any visit, but no study participants reported persistent pelvic pain of any kind at the 3-, 4-, and 5-year follow-up visits, according to Bayer.
"Essure is supported by more than a decade of science and real world clinical experience," vice president Dr. Edio Zampaglione said in a prepared statement "Bayer is strongly committed to providing access to a wide range of safe and effective contraceptive options for women, and we look forward to continued research on Essure."
Patients and a prominent activist struck up a hue and cry almost immediately after Bayer’s buyout of Conceptus, agitated for the device to be taken off the market and for Bayer to launch a complete investigation into patient injury claims. But in October 2013 the FDA said that real-world results don’t support reports of extreme fatigue, depression, weight-gain and other issues associated with the implant.
In February a citizens petition lodged with the FDA asked the safety regulator to take Essure off the U.S. market, alleging that the clinical data the FDA used to approve the device was fudged and that the company concealed adverse events associated with Essure.
Bayer has denied the allegations and pledged an aggressive legal defense against the accusations.