The pain of women who have encountered irrevocable damages after using Essure cannot be simply narrated. This video will give a deep outlook on the way in destroying the happiness of women who dreamt of a safe contraception. Get more insights by viewing the video.
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A faulty medical device has the potential to change people's lives. It is absolutely correct in the case of Essure birth control devices. Many women who used these devices were filing Essure lawsuits against the manufacturer for physical injuries. The company settled the first set of Essure implant lawsuits. However, the women who have been affected are waiting to file a claim.
The Essure birth control devices had to face lawsuits due to the negligence of the manufacturers. Women use Essure as a permanent birth control device. Essure inserts are about the size of a 4-centimeter coil and are made of stainless steel, nickel, titanium, platinum, polyethylene terephthalate (or PET) fibres, and silver-tin. The device's manufacturers claimed that it was 99.3 percent effective in preventing pregnancy.
Nausea, vomiting, bleeding, dizziness, cramping, and pelvic discomfort are some of the most common side effects of the birth control device. In addition to these side effects, about 8% of the women reported device failure because it did not prevent pregnancy, which was the primary goal of implanting the device. According to some women, the Essure implant corroded and migrated inside them, exposing them to nickel poisoning, inflammation, and uterine and other organ damage.
Since the date of approval, the FDA has received reports of Essure medical implant-related adverse events. The FDA ordered Bayer Healthcare to conduct a new clinical trial in February 2016, and it received a "black box" warning label in November 2016. According to reports, Bayer Healthcare paid out $413 million in Essure-related legal settlements in 2017.
Because of the pain, more than 80% of the devices were removed. The percentages are distributed as follows among the reasons for the removal. Pain: 60%, genital haemorrhage: 14%, device dislocation/migration/expulsion: 12%, perforation: 11%, suspected metal allergy: 3%, and device breakage: 3%. To remove the device, the majority of the women required one or more surgeries, such as hysterectomy.
The FDA is taking every precaution possible to ensure women's safety by attempting to understand the long-term complications of Essure. As a result, it can benefit both patients and healthcare professionals. To conduct the analysis, the agency continues to collect long-term safety data from women who have received Essure, as well as clinical data from post-market surveillance.
Even though the manufacturers had ceased sales, what they had sown had to be reaped. Despite successfully settling the first set of Essure lawsuits, the pending lawsuits continue to hang over their heads.
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