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FDA ISSUES HIGH RISK WARNING FOR VAGINAL MESH

Posted by Sarah Showard | Jan 05, 2016 | 0 Comments

The FDA announced on January 3, 2016 that trans-vaginal mesh products used to correct pelvic organ prolapse will now carry a class III warning which means that the products carry a high risk for adverse events.  Previously the mesh products carried a class II or moderate warning.  In addition manufacturers of the devices will also be required to submit to a premarket approval application to support the safety and efficacy of surgical mesh for the trans-vaginal repair of pelvic organ prolapse.

The move follows years of reports of pain, bleeding and infection among women receiving the implants.  Thousands of lawsuits are pending against the manufacturers of trans-vaginal mesh.  Showard Law Firm has been representing women effected by trans-vaginal mesh since 2011 and has recovered significant settlements for many women. There are strict time limits for filing claims so if you or a loved one has been injured by a vaginal mesh call today for a free consultation. 

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...

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Showard Law Firm is dedicated to compassionate representation for our clients who have been injured by defective products, dangerous drugs or the negligence of any individual or company. We are experienced in litigation and ready to ensure you receive the maximum possible settlement for your injuries, medical bills, mental anguish and other losses.

Sarah Showard and Dr. Peter Ott - 2018 Heart Ball Chairs

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Sarah and Peter are the proud chairs of this year's Heart and Stroke Ball, held on 2/17/18 at the El Conquistador. With a western theme "Heart of the West", this important fund raiser is in its 60th year, all raising funds to help with research and advances in the case against heart disease in the Tucson community.