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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 Women's Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorney, and has been representing plaintiffs since 1990. Sarah has a son, Benjamin, who recently graduated from The Gregory School and will attend ASU in the fall, with future plans to attend law school and eventually join Showard Law Firm. In her spare time Sarah enjoys horseback riding and spending time in Sonoita with her husband Peter.

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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.

Showard Law Firm celebrates 10 years

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2016 marked the 10th anniversary of Showard Law Firm. After 18 years of practice, and a prior ten-year partnership, Sarah Showard and her longtime assistant, Maria De La Rosa, opened the doors of Showard Law Firm in October 2006. Sarah and everyone at Showard Law Firm is proud to serve Southern Arizona as the local law firm for defective drug and medical device claims and personal injury.