On July 20, drug manufacturer Bayer formally announced the discontinuation of sales of their controversial Essure permanent birth control device. This comes months after the FDA issued a landmark order to the company, restricting sales and distribution of the device only to doctors who adequately communicate to their patients all the risks associated with use of the Essure device.
What is Essure?
Essure is a birth control device that is implanted into a woman’s fallopian tubes – the only permanent birth control that doesn’t require surgery or any incisions. Two metal coils are placed in the fallopian tubes, triggering scar tissue build-up in these areas. This acts as a physical barrier to prevent fertilization and pregnancy.
Essure Has Been Under Consistent Scrutiny
Essure was approved in 2002 by the FDA, but this unique form of birth control has been under constant review to fully ensure its safety and effectiveness among women. After a thorough investigation of the medical literature, clinical trial information, and medical device report data, the FDA ordered Bayer to conduct a post-marketing study in February 2016 to gain a deeper insight into the device under real-world conditions. Additionally, in November of that same year, the FDA required a boxed warning on the product labeling, suggesting potential adverse effects associated with use of the device.
The Serious Risks and Side Effects Associated with Essure
Despite approval, the FDA’s main concerns stem from Essure’s large, extensive list of potentially dangerous side effects. These include:
- Device migration
- Back and pelvic pain
- Heavy bleeding during menstruation
- Severe fatigue
- Allergic reactions
- Autoimmune diseases
- Weight changes
- Extreme changes in mood
- Organ perforation
Additionally, because Essure is a permanent solution, the installation of the implant is irreversible – the only option to remove the Essure device is a hysterectomy.
Despite Bayer’s Claims, Tens of Thousands Have Been Affected
Interestingly, according to Bayer’s official release, they cite reasons for discontinuing Essure as purely business-related:
“This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable. Essure is the only FDA-approved non-incisional form of permanent birth control.
The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades.”
To date, the FDA has received more than 26,000 medical device reports regarding any side effects associated with Essure – including ten reports that tie to eight adult deaths.
Take Action Against Bayer Today
If you or a loved one has suffered complications or have been seriously injured due to the implantation of an Essure device, contact the Mobile personal injury attorneys at Long & Long immediately to schedule your free consultation. We believe that companies like Bayer should be held fully accountable for misleading women and profoundly altering their lives.
Long & Long is dedicated to ensuring our clients receive the care necessary to protect their rights and receive the maximum recovery necessary. We maintain a rapid response policy so you can get the help you need as soon as possible.
Contact us today to explore your legal options against Bayer for negligence. Your first consultation is free, and we operate on a contingency fee basis – you don’t pay any fees until we recover damages on your behalf.