Thousands petition FDA to take dangerous birth control device off the market

Talk about passing the buck.

Thousands of women around the country have reported intense pain and horrible side effects from a birth control device called Essure. It’s a small coil that doctors implant inside a woman’s fallopian tubes to prevent pregnancy.

There are have been four deaths associated with the device. Women across the country have signed a petition asking the FDA to take Essure off the market, alleging fraudulent clinical trials.

Oh, and 4,500 patients and doctors have reported serious problems with the device to the FDA. Problems like splitting headaches, nausea, allergic response to the nickel in the device, perforated colons, and hundreds of women who were forced to have hysterectomies.

So what did the FDA do about it?

Well, it took the petition, bundled it up and sent it to their Office of Compliance to be handled as a “trade complaint.”

That’s something the FDA typically does when a company is accused of a marketing or promotional violation.

But not when people are dying. It’s like trying a murder in traffic court.

The Office of Compliance will be conducting its “investigation” in secret – and Essure victims (and the rest of us) will never get the results.

And if it looks like the FDA is trying to make the Essure controversy disappear, you’re right. In fact, they’re desperate to make it disappear.

The FDA didn’t just approve Essure – they did so under a special exemption that makes Essure’s maker, Bayer, impossible to sue.

These exemptions are supposed to be used to bring medical breakthroughs to market quickly – but they’re regularly exploited by companies to introduce unnecessary products that will never save a single life.

Now the FDA has egg on its face and is giving some lip service to Essure victims – even agreeing to meet some recently. These women told how Essure had “ruined” their lives, and put them in constant pain and suffering.

Even the official Essure website offers a glimpse at the horrors of the device. The site includes “Real stories from women with Essure,” and even those cherry-picked accounts aren’t problem-free.

Those “testimonials” mention pain, nausea, vomiting, fainting, vaginal bleeding and back pain.

“Don’t forget to check back for new stories as we hear more,” adds the copy on the product site.

I think we’ve heard enough.

Source:

“FDA opening investigation into permanent birth control device Essure after reported health problems” Heather Catallo, April 2, 2015, ABC 7, wxyz.com