FDA Restricts Sale of Birth Control Device

FDA Restricts Sale of Birth Control Device

The FDA will restrict sales of Bayer’s Essure birth control device. This new safety measure is being enforced because the agency discovered that some women were getting the birth control device implanted, but weren’t adequately informed about the risks.

“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA Commissioner Scott Gottlieb said in a statement.

“Despite previous efforts to alert women to the potential complications of Essure,” he continued, “we know that some patients still aren’t receiving this important information. That is simply unacceptable.”

Because of this, the sale and distribution of Essure will now be limited to healthcare professionals who agree to review and discuss the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement.”

This checklist will be used to verse patients and doctors on the risks and benefits of the birth control device. Patients will be required to sign the decision checklist before they move forward with the procedure.


Alanna McCatty

Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.


Did you find this article helpful?

No votes so far! Be the first to rate this post.


Latest News

Belviq, ActiPatch, Free Samples, Dollar Tree Drugs

Belviq, ActiPatch, Free Samples, Dollar Tree Drugs

We knew it was too good to be true – free and cheap drugs aren’t worth it. Also, taking a magic pill to lose weight could give you cancer (!). One ray of sunshine: a pain therapy device using shortwave is now available over-the-counter. Have a lovely Valentine’s Day! Be…

Flouride, PPIs, Breast Density and Prostate Cancer

Flouride, PPIs, Breast Density and Prostate Cancer

Startling news about fluoride, a study encourages more limites use of PPIs, does knowing the density of your breasts matter, and vegetables aren’t helpful in warding off prostate cancer (darn).  Be Well.  Fluoride and Pregnancy The medical community was shocked at the conclusions of two new studies on fluoride’s effect…

  • Advertisement