Pharmaceutical giant Bayer is in hot water over their “permanent” birth control product, Essure. This is an implant that was originally approved by the FDA back in 2002, which claims to be an effective and non-invasive alternative to surgical procedure.
As promising as the product seemed to be at that time, the consequent problems from using Essure has now surfaced, with claims that it is not as safe as the manufacturers made it sound to be. Essure has two small metal coils that are designed to be inserted into the woman’s fallopian tubes. This is meant to block the eggs from traveling through the fallopian tubes by wrapping these coils around the tube and closing off the pathway.
The idea is to actually create a permanent scar tissue using this implant by breaking through the skin of the fallopian tube. What tends to go wrong, though, is that the metal coil parts can break. Broken metal can cause allergic reactions, and not to mention have solid parts actually moving from one part of the body to another.
Prolonged exposure to heavy metals can lead to auto-immune diseases. This is on top of the usual discomfort and pain that women with the Essure implant experience, such as abdominal pain.
There have also been reported cases wherein the woman’s uterus and fallopian tubes have been perforated by the broken implant. For some, the metal parts have migrated to the pelvic region, which results to even more pain. And for all that pain, it doesn’t even work effectively as a birth control.
The question then is, if Essure isn’t safe, then why did the FDA give its seal of approval? Apparently, FDA gave a pre-market approval based on the details provided by Bayer alone. As for the actual testing, it never really happened.
With all these details coming out about Essure, critics are now hitting at the FDA for supposedly failing to guarantee the protection of the consumers against faulty drugs and related products in the market. What makes it worse is that this pre-market approval apparently makes it difficult for claimants to build a case against Bayer
Getting Legal Help
Law firms like Gordon & Doner are needed to help represent women who may have suffered, or are suffering, from the side-effects of Essure.
Building a case against the pharmaceutical giant may be a great challenge, but recompense must be given to those who deserve it.