The only permanent, non-surgical form of birth control on the market for females, Essure, was supposed to offer women the unique opportunity of taking control of their reproductive health in a way that was low-risk, affordable and long-lasting. However, soon after its approval by the Food & Drug Administration (FDA) in 2002, reports of the medical device’s adverse effects began flooding in.
Between 2002 and 2015, the FDA received over 9,000 reports of Essure adverse effects, while Bayer, the manufacturer of the birth control method, received over 15,000 reports of adverse effects.
If you have been harmed by an Essure implant, you have rights – and you may be entitled to compensation under the law. Currently, a number of women have filed lawsuits against Bayer following traumatic experiences with Essure, arguing that:
Essure is a dangerous and defective medical device
Bayer did not properly test Essure before releasing the product
Bayer was aware of Essure issues that were not shared with the public
Bayer violated federal safety regulations
Essure does not come with proper warning labels
What is Essure Birth Control?
Essure was designed to be a permanent type of birth control that was less invasive and expensive than the surgical option of tubal ligation (in which each fallopian tube is tied off, preventing eggs from descending into the uterus for fertilization).
Essure consists of two thin nickel and titanium alloy coils, each of which is inserted into each of a woman’s fallopian tubes. Over a period of three months, scar tissue builds around the coils, holding them in place and blocking eggs from traveling into the uterus. When inserted and used correctly, the birth control option is supposed to be 99 percent effective, according to manufacturer Bayer.
Almost a million Essure devices have been sold today, mostly to women in the United States.
Essure Birth Control Adverse Effects & Complications
While Essure seems like a innovative and reasonable birth control option for women who are sure that they are don’t want more children, it quickly became apparent that Essure posed a number of risks and led to a number of complications. Some of these complications and outcomes were painful, permanent, and heartbreaking.
The most common adverse effects and complications reported by women about Essure include:
Abdominal pain and cramping
Irregular periods
Bleeding
Nausea
Chronic fatigue
Chronic headaches
Painful sex
Allergic reactions
Autoimmune reactions
Rashes
Hair loss
Organ perforation/puncturing
Device migration
Pregnancy
Ectopic pregnancies
Miscarriages and fetal death
These medical problems have had serious consequences for women and their families, including:
It is no secret that Essure has caused serious medical problems in women or that it causes unintended pregnancies and fetal deaths. In fact, both the FDA and Bayer have admitted that the medical device needed more research, product safety improvements, and better warning labels. Here is a timeline of some of the major events surrounding Essure:
2002: Essure was approved by the FDA as a permanent, non-surgical birth control device for women.
2011: A warning is added to the box that women with nickel allergies should not use the device.
2013: Bayer purchases Essure from Conceptus Inc.
2013: A warning is added to the box about the risk of device migration and associated chronic pain.
2015: The FDA held a meeting of its Obstetrics and Gynecology Devices Panel, which reviewed Essure adverse outcomes and made a number or recommendation to Bayer on making their product safer.
2015: The FDA orders Bayer to conduct more post-marketing research on the device in order to understand the actual risks women are taking when using the Essure.
2015: Congressman Mike Fitzpatrick, a Republican from Pennsylvania, introduced a bill calling for an Essure recall, since the FDA did not act to do so.
2016: The FDA issues a “black box warning” for Essure.
Talk to Us About Your Essure Experience in Boston Today
You are not alone. Many women have spoken to lawyers about their painful experiences with Essure birth control. You and thousands of other women may deserve compensation for Bayer’s negligence, including compensation for medical bills, lost wages, disability, and pain and suffering. If you have suffered in the wake of an Essure procedure, you may wish to speak with an experienced defective medical device attorney today. Call (617)-391-9001 or contact us online and schedule a private, confidential consultation with one of the lawyers at Sweeney Merrigan Law. We want to hear your story and we want to help. We have the best personal injury lawyers in the Boston area.
Meet the Personal Injury Attorneys at Sweeney Merrigan Law, LLP
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