|Essure--Screenshot courtesy of Bayer|
Bayer is facing more bad news for its contraceptive implant Essure, as a new study shows that women outfitted with the company's device are more likely to need follow-up surgeries compared to individuals who undergo a traditional sterilization procedure.
Scientists analyzed coding data on medical records of about 52,000 women from outpatient ambulatory surgical centers in New York state between 2005 and 2013, and found that one year after receiving an implant, 2.4% of Essure patients required follow-up surgery. Only 0.2% of women who underwent minimally invasive laparoscopic sterilization required an additional procedure.
When all is said and done, the 2.4% number translates into about 21 additional surgeries per 1,000 patients getting an Essure implant, the researchers said in the study. Scientists published their findings a recent issue of The British Medical Journal.
"Small risk in large numbers of patients translates into large numbers," study leader Dr. Art Sedrakyan, professor of healthcare policy and research at Weill Cornell Medicine in New York, told Reuters. If the New York stats for Essure were applied to the rest of the U.S., it would mean about 150,000 patients need follow-up surgery, Sedrakyan said. And "(i)n some instances, these re-operations are quite major surgeries" such as hysterectomies, he added.
Unsurprisingly, Bayer is not buying the researchers' numbers. The study was "based on a single database of one U.S. state" and doesn't take into account patients who may have had Essure implantations in doctors' offices, the company told Reuters in a statement.
Still, the findings do not bode well for Bayer as it contends with mounting pushback over its device. The FDA has received more than 5,000 complaints about Essure since it was approved in November 2002, with most of them from after Bayer acquired the device through its $1.1 billion deal for Conceptus in 2013. About 750,000 women use Essure worldwide, and 70% of them are in the U.S., according to the Reuters story.
In 2014, the FDA said it would investigate the product. Bayer then released data from a 5-year follow-up study showing that Essure caused pelvic pain in only 7% of participants. But some experts in the field struck back, saying that only some participants in the original study were followed for the full 5 years and that some women still experience serious problems with the device. Essure consists of two flexible metal fiber coils placed in the cervix and is partially made from nickel, a material that could trigger allergic reactions in women who received the implant, some critics say.
Last month, the FDA convened an independent panel of experts to discuss Essure's risks and benefits and to see whether it should face heightened scrutiny. The panel urged the agency to review additional studies examining the device's safety, and chastised regulators for approving the product without a gold-standard, randomized clinical trial. While the FDA is not bound by its panel's advice, it generally follows its recommendations.
Special Report: Med tech M&A gets much, much bigger during the first half - Bayer doesn't conceive with Conceptus