A new study found that women implanted with the permanent contraceptive Essure were 10 times more likely to have additional surgeries within one year than women who chose to have their tubes tied. Our team of Essure attorneys is now accepting claims on behalf of women injured by this device.
This new study examined data from more than 50,000 women who underwent sterilization procedures in New York between 2005 and 2013. About 8,000 of these women opted for the Essure implant, which involves inserting flexible coils into the fallopian tubes. Over a period of three months, tissue grows around the coils, creating a barrier so sperm cannot reach and fertilize the eggs.
Among the 8,000 women implanted with Essure, nearly 2.5% had to return for another operation within the first year. Only 0.2% of women who had tubal ligation, or their tubes tied, needed another operation. Most of the surgeries required for Essure patients were due to complications like device failure. This means that re-operation rates were 10 times higher with Essure than traditional sterilization procedures.
Essure was also associated with higher medical bills, with the average woman charged about $7,800 for the device, compared to just over $5,000 for surgical tubal ligation.
Over the past few years, the public, FDA and medical specialists have become increasingly aware of the growing number of severe complications. Among them include:
- Chronic pelvic pain
- Device migration
- Severe migraines
- Wrongful death
- Ectopic pregnancy
- Allergic reactions
- Puncture or tear of uterus or colon
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Because the actual rates of failure and complications are much higher than Essure’s manufacturer initially stated, many critics are accusing it of fraud. Bayer, the company that makes Essue, has been accused of not disclosing its clinical trial results accurately to the FDA. The FDA relies on clinical trial data to approve all new medical devices and drugs as safe and effective.
More than half a million women are sterilized each year, typically through traditional tubal ligation. Essure has been growing in popularity since it was approved 13 years ago, touted as a less-invasive, shorter procedure that will still provide permanent sterilization.
In September 2015, after more than 10,000 reports of serious complications from Essure, the FDA held a daylong meeting about the device. Experts at the agency condemned Bayer for failing to collect data that could have helped predict and prevent risks to women, and cited several calls to have the device pulled from the market.
These critics say that Essure should be removed from market until Bayer admits to skirting approval conditions or completes clinical trials free from fraud. Meanwhile, thousands of women throughout the country have been forced to undergo hysterectomies and years of pain and suffering from the device. They were told Essure would provide sterilization without disrupting their busy schedules, only to find themselves in and out of doctors offices for years on end and suffering debilitating pain.
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That is where we come in. We are currently investigating injury cases involving the Essure implant. If you or someone you love received Essure, contact our firm for a free legal consultation. You may be entitled to compensation for your medical bills, lost wages, and emotional distress. We accept clients nationwide.