GlobalData analyst Joseph Gregory says public advocate Erin Brockovich's patient safety claims against Bayer's Essure contraceptive implant are "inappropriate" and "unsubstantiated."
Healthcare giant Bayer (PINK:BAYRY) has another ally in the battle over its Essure contraceptive implant, with medical device analyst Joseph Gregory coming out against high-profile public advocate Erin Brockovich and her new interest in a growing outcry against the Essure procedure.
Gregory called Brockovich's claims against Essure "inappropriate" and "unsubstantiated," saying that the arguments against Essure fail to appreciate the less-than-1% apparent major adverse event rate and the thousands of patients helped by the device.
"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 benefitted 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."
There are some 800 reported cases of adverse events associated with Essure, among around 16,300 physicians who have performed the procedure at least once, Gregory said. Even assuming that each of these physicians had only performed ten of these procedures in total, this provides an estimated US procedural volume of 163,000. That suggests an adverse event rate of about 0.5%, a figure that falls in line with more than 200 published reports on Essure's performance.
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.
Brockovich called for a wide-scale recall of the Essure devices and for Bayer to conduct a thorough investigation into patient injury claims, a move that Gregory chided.
"For Ms. Brockovich to suggest that the device 'does not work' is to deprive it of its excellent performance in the estimated 15,500 patients who were adverse event-free," Gregory wrote. "Decisions to recall must be made on evidence-based results, not anecdotal information."
Gregory's support joins comments made by FDA regulators, who said last month that the rising tide of Essure complaints of extreme fatigue, depression, weight-gain and other issues associated with the implant aren't supported by real-world results.
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 the 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.
Essure is part of the product portfolio that Bayer acquired in the $1.1 billion buyout of Conceptus, which the companies announced earlier this year. Conceptus won FDA approval for Essure in 2002.
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. Essure is the only permanent contraceptive option that requires no incisions, the FDA said, and the device contains no hormones and can be placed without need for anesthesia.
The FDA slaps Spacelabs Healthcare with a Class I recall of its Arkon anesthesia system due to a...
Here's a look at some of the top funding stories for medical device companies this week.
FDA officials warn against the use of "laparoscopic power morcellation" for the removal of uterine...
Bio-artificial liver maker Vital Therapies takes its IPO even lower, now planning to open at $12 per...