MASSDEVICE ON CALL — The anti-Essure movement, launched by women who claim the permanent contraceptive implant left them with severe pain and injuries, doesn’t look likely to die down, having spawned Facebook support pages, Twitter campaigns and lots of media attention.
The movement has attached itself to the Twitter hashtag ‘#EssureRally’, through which women are calling on Bayer to recall the device, posting pictures of the ralliers in action and organizing real-world events, including street-corner picketing and conference calls with famed consumer advocate Erin Brockovich.
The story has even driven passionate reactions here on MassDevice.com, where ralliers have called on Bayer to release its full clinical study reports and chided the FDA for failing to issue a recall on the device.
The FDA late last month commented on the growing anti-Essure movement, saying that real-world results don’t support reports of extreme fatigue, depression, weight-gain and other issues associated with the implant. The FDA said that it reviewed adverse event and complications reports, 5-year post-approval study results and clinical literature on Essure, concluding that there was no reason to believe that the device was connected to new complaints.
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.
Anti-Essure ralliers challenged the 5-year study, saying the results have been under wraps for too long and that their conclusions are inevitably biased, having been reported by "manufacturer paid consultants," according to one commenter.
The movement also took issue with medical device industry analyst Joseph Gregory, who came out against Brockovich’s recent interest in Essure, saying that the device helps thousands and bears a less-than-1% apparent major adverse event rate.
"While the reported adverse cases are very serious and represent potential issues with the Essure device, or the procedure itself, they have to be considered in reference to how many patients in total have utilized and benefited from this procedure," Gregory said in an official statement sent to MassDevice.com. "Although the adverse event profile may seem immensely large when highlighted, it isn’t large enough to surpass 1%."
"This doesn’t mean that Ms. Brockovich should stop being a resource for women who are interested in undergoing the procedure, or who have a medical story to share," he added. "However, her resources would be better directed to where the evidence supports her argument."
Brockovich, the activist made famous by Julia Roberts’ portrayal in a 2000 blockbuster film, announced last month that she was taking an interest in Bayer and the Essure device after her organization was inundated with hundreds of inquiries from women who claimed the device had left them with serous issues. The reports included chronic pain, including colon perforations caused by movement of the device, implants that have been lost and are no longer visible on scans, pregnancies despite the presence of the implants and debilitating headaches, according to Brockovich’s website.
Essure is a permanent form of birth control, comprised of flexible inserts that are implanted in the fallopian tubes where scar tissue forms around them to prevent fertilization. The procedure is incision-free, is done on an outpatient basis and takes all of 10 minutes to perform, according to Bayer’s online materials.
Essure is part of the product portfolio that Bayer acquired in the $1.1 billion buyout of Conceptus (NSDQ:CPTS), which the companies announced earlier this year. Conceptus won FDA approval for Essure in 2002.
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