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Study Says FDA Should Have Banned Pelvic Mesh Much Sooner

By Brian Chase on March 3, 2020 - No comments

C.R. Bard to Pay $60 Million for Deceptive Marketing with Vaginal Mesh Devices

C.R. Bard to Pay $60 Million for Deceptive Marketing with Vaginal Mesh Devices

Researchers with the U.S. Food and Drug Administration (FDA) who conducted a long-term study of women implanted with transvaginal mesh to treat pelvic organ prolapse (POP) concluded that the FDA should have banned the products sooner than it did. According to a report on Mass Device, the study of 54,194 women in New York State revealed that women treated with mesh had an 8.8% risk of re-intervention five years post-surgery compared with 6.3% in the same size group of women treated differently for the same condition.

Significant Risk from the Implants

This 40% increased risk was observed across all levels of hospital volume in performing POP procedures, the researchers said.  The observational study paired more than 12,000 women in each group and is a follow-up to the same researchers’ review of patients 12 months after receiving the devices. The research team comprised doctors from several hospitals and published their results in the journal Obstetrics & Gynecology.

The FDA reported more than 1,000 adverse events relating to transvaginal mesh implants in 2008 and reclassified the product from moderate-risk Class II designation to high-risk Class III in 2016. The FDA eventually ordered manufacturers to stop selling the product in the United States in April 2019 citing a lack of manufacturers providing reasonable assurance of the long-term safety and effectiveness using the mesh.

Researchers said the United States government was late to ban vaginal mesh implants in spite of an overwhelming number of safety warnings and adverse events reported by patients. Despite the ban, they say, data suggests that the risk of complications from mesh implants does not diminish over time and that the women who received them require close follow-up.

Horrific Complications

Women who received these transvaginal mesh implants reported horrific side effects including inflammation, chronic pain, mesh shrinkage and embedding in scar tissue, infection, bleeding, pain during sexual intercourse, organ perforation, protrusion through the vaginal wall and urinary problems. So far, manufacturers of these products have paid out millions of dollars in legal judgments and settlements and the lawsuits still keep coming.

Our product defect lawyers have represented a number of women who have gone through and continue to go through these horrible side effects. We are passionate in our pursuit for justice for these women who did not receive adequate warnings about these side effects before they were implanted with these defectively designed mesh devices. If you or a loved one has suffered complications as a result of receiving transvaginal mesh devices, please contact an experienced product defect attorney to obtain more information about pursuing your legal rights. You may be able to seek compensation for damages such as medical expenses, lost wages, cost of surgery, permanent injuries, disabilities, loss of livelihood, loss of life’s enjoyment and past and future pain and suffering.

 

Source: https://www.massdevice.com/study-fda-should-have-banned-pelvic-mesh-long-before-it-did/

Posted in: Defective Medical Device

About the Author: Brian Chase

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