Once again, the FDA is lax on safety, allowing industry to rack up a few extra sales

Nickel for your thoughts

It’s almost like a rite of passage here at HSI…

The day it clicks and you realize the FDA is definitely not here to protect you.

The day you learn that the FDA is a shill for the drug and medical device companies…more concerned with protecting corporate profits than mere people like you and me.

For some it takes weeks. For some months. But that same light bulb goes on for everyone.

And last week, when we heard Lynn’s story in our own weekly staff meeting, it was like a light show here.

No worries…for them!

“I thought you were all a little over the top. Until I clicked through the Google search. At first, I thought ‘See…the FDA got it right.’ But then I clicked all the way through.”

Lynn shared this personal story with us…and said it was okay to share it with you.

She had gotten Essure, a permanent birth control method. It’s an outpatient procedure where your doctor inserts a spring-like device into your fallopian tubes. The device contains Nitinol, a nickel titanium alloy.

But just weeks after her Essure procedure, Lynn was feeling lousy. After digging deeper, she wondered… “Could I have a nickel sensitivity? Could this be a reaction?”

So… To Google. Right away she found this partial sentence in the queue of search results… “Conceptus Announces FDA Approval to Remove Nickel…”

See…there it is! The FDA…protecting women.

But when she clicked through on the link to the 2011 press release, the full title turned out to be quite different… “Conceptus Announces FDA Approval to Remove Nickel Contraindication From the Essure Procedure Instructions.”

That’s right. The nickel sensitivity warning had been there. But after what I assume was a good deal of lobbying, begging, and cajoling the agency gave in and said the manufacturer could remove the warning.

They weren’t removing the nickel, just the warning.

Conceptus 1; Lynn and other women 0

The FDA apparently based this decision on a study that found nickel sensitivity reactions to be rare.

I’m not sure where they got that study but my research shows 10-15% of women have some level of nickel allergy. It’s one thing when a ring turns your finger green and you can take it off. It’s another issue entirely when you have it implanted in your fallopian tubes every minute of every day.

I wonder if anyone at the FDA has seen the “Essure Problems” page on Facebook. It’s for women who “are suffering or have suffered” from Essure side effects. The group has nearly 1,500 members so far.

Or I wonder if they’ve looked at any of the blogs that feature personal stories behind Essure side effects.

Picking one of these blogs at random (essureproblems.com), one woman describes her nickel sensitivity reaction. Her symptoms included chronic pain, bleeding, weight gain, abdominal burning, headaches, dizziness, nausea, and brain fog.

Many of these symptoms would show up in cycles…along with a nickel taste in her mouth.

After enduring months of anxiety, her story finally ended well. She returned to good health when her surgeon removed the Essure device.

Meanwhile, the Essure website describes Essure as, “Worry free.”

Hmmm… Maybe that’s supposed to describe the way Conceptus executives felt when the FDA cut them loose from that annoying nickel sensitivity warning.

Lynn is deciding what to do about her Essure. But her FDA light bulb is glowing pretty brightly these days.

Sources:
“Adverse events due to suspected nickel hypersensitivity in patients with essure micro-inserts” The Journal of Minimally Invasive Gynecology, Vol. 18, No. 4, July 2011, jmig.org

“Conceptus(R) Announces FDA Approval to Remove Nickel Contraindication From the Essure Procedure Instructions” Conceptus, Inc., 8/4/11, investor.conceptus.com

“Essure Problems and Survival — A Woman Gives Her Story” Essure Problems, April 2012, essureproblems.com

“Essure Problems Continue Among Women” 3/6/10, vervilledeb1.wordpress.com