Critics of Lucine and our e-journal Hormones Matter often suggest that we are biased against the pharmaceutical and medical device industries and that, we should trust the FDA on all matters of women’s health. After all, we wouldn’t want to be considered one of those wacky conspiracy, alternative health blogs or a bunch of mommy bloggers (for reference, I rate moms as some of the best arbiters of BS when it comes to health). Admittedly however, much of the information on the blogosphere is horribly slanted or so devoid of actionable intelligence that it offers no more than pablum – even from the more reputable sources. But I digress.
With those criticisms come claims that begin with the ‘FDA approved…’ a particular treatment or device, or ‘after reviewing the data, the FDA found no merit to’ research suggesting that a certain drug or device was indeed dangerous. I have to admit that it often feels like I am biased. Perhaps I am little less apt to trust this industry or the regulatory oversight than others. I am certainly wary of the magic pills (oral contraceptives, HRT, anti-depressants) that are marketed as cures for all that ails the female population (without supporting data). But then, just when I think it is safe to trust again, reports like this come to light.
J&J Sold Vaginal Mesh Implant After Sales Halt Ordered
Bloomberg News reported last week that Johnson and Johnson (J&J) continued to sale Gynecare Prolift, a vaginal mesh implant, for a full nine months after FDA ordered it to halt sales. Prolift is a surgical mesh device used to treat pelvic organ prolapse, a common condition in women who have had children.
The basis of the complaint was the five-fold increase in death and serious injury associated with this product.
Bloomberg News reports:
J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.
J&J determined the safety of this product on its own. Called ‘equivalence’ this is a common form of FDA approval requiring the applicant show merely that a device or test is ‘equivalent’ to some older, previously approved device or test. With low risk devices or tests this is a mostly reasonable way to garner approval. In higher risk devices, however, such as those that are surgically implanted, meeting equivalence is hardly sufficient for approval, especially if the older devices are themselves, dangerous or otherwise inadequate.
While the FDA ultimately “…disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter…” to halt sales, this was 2 years after J&J had already been selling the products to surgeons. By then hundreds of millions of dollars had been made and tens of thousands of mesh products had been implanted in women. J&J ignored the letter and continued to sell Prolift.
What’s worse than J&Js blatant disregard for the human safety is that the FDA ultimately caved and cleared the product in 2008, despite the fivefold increase in death and serious injury. Even a halted clinical trial failed to incite sufficient motivation to remove this product from the market. In 2009, the clinical trial designed to evaluate the safety of Prolift was halted when researchers found that >15% of women experienced erosion. Erosion of the mesh caused “pain, scarring, painful intercourse, bleeding scarring and closing of the vagina eroding into the bladder and bowel. Mesh erosion through the vagina is also called exposure, protrusion or extrusion. Many of these problems required additional medical or surgical treatments and further hospitalizations.” Despite the findings of the clinical trial, the products remained on the market.
As of 2010, J&J had reported sales of $295 million in the US alone. J&J did agree to re-label the device and in 2011 the FDA began considering re-classifying vaginal mesh products from a moderate risk product to a high risk product. I guess we should be grateful (insert snark). In the mean time, women continued to suffer and die. It is only recently, after hundreds of lawsuits, that J&J applied to recall Prolift and other vaginal mesh products. According to a J&J spokesperson:
“We came to this decision after carefully considering numerous factors” including “the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regulatory environments in which we operate, and the availability of other treatment options for women,”
Notice, that it was market factors, not product safety, behind the decision. The report goes on to say that products will be phased out on a region by region basis over the next year. I guess there is no rush to recall these products since J&J admits no health or safety concerns and the FDA approved the product. I sure would hate to be the last region in the recall.
So no, I do not trust the FDA to protect my health. I am afraid many other women, some of whom are mommy bloggers (yes, I am a mom and I blog), scientists and proponents of better health don’t either. Yet, we still must make decisions that affect our health and our family’s health. To all the women responsible for family health decision: verify, then trust.
Resource to Verify Medication Safety
AdverseEvents.com : this is a fantastic site run by a private company that allows individuals to list and view adverse events and side effects for every medication on the market. It is free to the user. If you are an Yaz, Yasmin or Ocella user, I encourage you to look up those medications and compare their side effect profiles to other drugs. This site does not list medical devices. If any of our readers know of a similar site for adverse events associated with devices, please share.
Dear Doctor Chandler, would you be willing to help support Patients of Failed Implant Devices and Materials Alliance by visiting our facebook organizational page, and if in agreement with our alliance mission and vision mission allow your name to be added to a supporting physicians list ?
Hi Nonie, I am not a physician but a PhD. If you send me the info, I would be happy to review and support. Also, we host patient stories on a regular basis, if you’d like encourage patient stories on this blog, we’d be happy to publish and share broadly to get the word out. Contact me directly via the Write for Us link in the right column of the blog and we can chat. Thanks for reaching out.
Were these products cleared for women with genetic tissue diseases? I suffer from ehlers danlos syndrome and was told it would be the best thing for my tissues to hold. I am 38 years old and a single mother with three young daughters who has lost everything. I finally had removal surgery on march 4th and now i use a constant catheter. I was a healthy active mom, police officer, skating and gymnastics coach and i had a future being active with my children. I live in a small town and have been nicknamed razor crotch and have lost my self esteem and my love of life. I have had addiction, depression, anxiety and my father died a week before my surgery. I spent 8 years seeing specialists at the mayo clinic for fevers that could not be explained until now. Polypropelene is warned not to be heated or frozen so what does it do in a female body who’s temperature is always 101 degrees and gets to 104 degrees weekly. I am scared to know what the polypropelene has leaked into me. What kind of cancer it will cause. I would be veru interested in being in touch with women who have suffered elevated ace levels, fuo (fevers of unknown origin) torticollis, bronchitis and chronic pneumonias and granulomad in the lungs as well as lymph node problems. God bless all of the suffering and i hope those bastards pay for stealing innocent lives!
Would you be interested in writing a blog post to share your experience? Perhaps, then we can see if other women experienced the same symptoms.
More on equivalence and the IOM’s review of the FDA’s 510k process:
“The law states that a moderate-risk device that is substantially equivalent, or similar, to any previously 510(k)-cleared device or any device that was on the market when the Medical Device Amendments were enacted—referred to as a predicate device—can be cleared for marketing with some exceptions. When the FDA assesses the substantial equivalence of a device, it generally does not require evidence of safety or effectiveness; and when a device is found to be substantially equivalent to a predicate device, the new device is assumed to be as safe and effective as the predicate because of its similarity. Devices that were on the market before the Medical Device Amendments were never systematically assessed for safety and effectiveness—but they are being used as predicate devices. This leads the committee to find that 510(k) clearance is not a determination that the cleared device is safe or effective. The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one.”
http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/Report-Brief.aspx
Are all vaccines considered “Medical Devices”? Why wouldn’t it be considered a medication? I’ve got some work cut out for me on this one – I’m determined to get to the bottom of this!