News

FDA Takes New Measures to Inform Women of Essure Risks

In April 2018, a national movement of women suffering from painful side effects caused by Essure achieved two major victories: On April 9th, the FDA ruled that health care providers can no longer implant Essure unless the doctor and patient review and sign an FDA-approved document outlining the risks. The following week, the FDA announced new guidelines in approving medical devices for U.S. patients.

FDA Commissioner Scott Gottlieb noted that some women receiving Essure have not been fully informed about the risks associated with it: “Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information.”  Even with warnings in place, Essure is still available in the U.S., though it has been removed from the market in other countries.

If you or a loved one has been hurt by the Essure implant, please call our attorneys at 888-985-7228 for a confidential evaluation of your potential claim.

First Biomet M2a Metal-on-Metal Hip Trial Scheduled for September 2018

A Fort Lauderdale, Florida court will hear Biomet’s first trial concerning its M2a-Magnum metal-on-metal hip replacement device in September 2018. Like many other complaints lodged against metal-on-metal hip implant manufacturers, recipients of the Biomet device claim to have suffered injuries such as tissue damage and progressive pain leading to device replacement.

If you or a loved one has experienced complications after receiving a metal-on-metal hip implant, please contact us by calling us at 877-790-3588 for a confidential evaluation of your potential claim.

FDA Releases Statement on Essure Review

On March 7, 2018, FDA Commissioner Scott Gottlieb released a statement regarding the agency's ongoing monitoring and investigations into issues related to Bayer‘s controversial birth control device Essure. More than 750,000 women have received the implant since Essure’s approval in 2002. As of December 31, 2017, the FDA has received 26,773 medical device reports related to Essure describing adverse events such as such as abdominal pain, abnormal uterine bleeding and device migration. In the statement, Mr. Gottlieb noted that the FDA is working to gain more information on the influx reports.

In response to the medical device reports, the FDA first convened a panel of medical experts in the fall of 2015 to better understand concerns regarding Essure. In February 2016, the agency ordered Bayer to conduct a postmarketing study to evaluate the device’s safety. Later that year, the FDA mandated that a black box warning be added to Essure’s labeling and a Patient Decision Checklist be discussed between physicians and their patients to inform patients of the risks of the device. Last September, Bayer halted sales of Essure outside the US.

If you or a loved one suffered complications after receiving an Essure implant, please contact us by calling us at 888-985-7228 for a confidential evaluation of your potential claim.

Women in Scotland Sue Essure Birth Control Maker After Becoming Pregnant or Experiencing Severe Pain

Nine Scottish women are suing the makers of birth control device Essure after becoming pregnant post-implantation. The device was billed as a simple and safe procedure and an alternative to sterilization, yet many of the women claimed to have experienced excruciating pain, bloating, bleeding and infections. Moreover, the women who became pregnant while implanted with Essure were at risk of ectopic pregnancies and miscarriages.

The European Union suspended Essure’s license for 90 days in August 2017 because Bayer failed to provide information during a routine product review. In September, Bayer stopped selling Essure in the UK and Europe reportedly for “commercial reasons.”

If you or a loved one has suffered negative side-effects after receiving the Essure birth control implant, please call us at 888-985-7228 to speak confidentially with an attorney about your potential claim.

Metal-on-Metal Hip Replacement Revision Rates Increased Since 2007: Study

Metal-on-metal hip implants have been alleged to cause metal particles to be released into the bloodstream and surrounding soft tissue. This can result in metallosis and often necessitate painful and more complicated revision surgery, in which the device is removed and replaced by an entirely new device. A new study published in the January 2018 issue of the Bone and Joint Journal indicates that revision rates increased significantly among recipients of metal-on-metal hip replacements after 2007. Involving over 24,500 patients who underwent hip replacement surgery between 2003 and 2012, the study concluded that device recipients from 2007 onward had a higher rate of revision at 5-years post-op compared to those who were implanted with the device prior to 2007.

If you or a loved one has experienced complications after receiving a metal-on-metal hip implant, please contact us by submitting the contact form or by calling us at 877-790-3588 for a confidential evaluation of your potential claim.

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