The permanent birth control device known as Essure has raised various concerns with women across America. The contraceptive implant has shown recent risks of chronic pain, bleeding, damages to the fallopian tube and even possible post operative surgery.
When originally introduced by Bayer, Essure was advertised as a surgery-free substitute to minimally invasive laparoscopic surgery as it can simply be implanted through the vagina.
However, more and more women whom have been regular users of this product have allegedly ended up in the hospital for further operations to fix the problem.
Dr. Art Sedrakyan of Weill Cornell Medicine in New York released the following statement in the British Medical Journal, “the risk of having a second procedure was 10 times higher in women who got Essure than among women who got laparoscopy.”
With all of that, Bayer, stands firm with belief in their product, claiming that “over a decade of research and development and a decade of real world experience supports the safety and efficacy of Essure.”
The product was allegedly nearly removed off the market by the FDA as they received numerous petitions from women everywhere. Obviously, women want non-surgical contraceptives.
Rather the FDA announced on Monday that a boxed label warning would be added to the product to alert its users and prescribers. They are currently probing for public input for the proposed label.
Bayer has also been directed to conduct more assessments for risks in different groups of woman. They have also been advised to study factors such as “unplanned pregnancy, pelvic pain and surgical removal of the product.
Now we all known how lengthy research can be. It may take Bayer years to conclude such research, and possibly more years to complete it. Let’s add the time in which it will take the FDA to release the warning label, now that surrenders the users of Essure at their own risk.