FDA Raises Awareness On The High Risks of Vaginal Mesh Implants

Posted by Jeremy Rosenthal | May 18, 2016 | 0 Comments


Over the past two (2) years, there has been a dramatic increase in the number of reported injuries and even deaths by Colorado women who have had vaginal mesh implants inserted to prevent or repair the collapse of pelvic tissue and internal organs. Consequently, there has been a correlating increase in the number of personal injury lawsuits filed against the manufacturers of these implants. Likewise, the national Food and Drug Administration (FDA) have decided to label vaginal mesh implants as “high risk” products.

By designating these implants high risk, the FDA will now require manufacturers of mesh implants to abide by increased safety regulations before their implants can be approved for sale by the FDA. For medical supply manufacturers who have already received approval for existing mesh implant models, they will have to submit new applications demonstrating compliance with the FDA's new rules. In turn, the FDA will apply a more rigorous safety review of a manufacturer's proposed implant.

The new FDA requirements come on the heels of years' worth of complaints from patients who have had mesh implants inserted, as well as the recent spike in litigation over the injuries caused by them. Some of the women who filed these complaints reported complications including serious infections, pain and vaginal bleeding. Many patients required numerous surgeries to adjust, replace and/or remove their mesh implants. Two (2) of the major medial manufacturers sued for faulty or unsafe implants include Johnson & Johnson as well as Endo International. To date, Endo International has settled over 20,000 personal injury lawsuits alone involving vaginal mesh implants, totaling over $830 million.

Companies such as Johnson & Johnson and Endo International who have manufactured faulty or defective medical products, like vaginal mesh implants, may be found liable for the damages these products cause under a theory of products liability. Product liability laws and liability is meant to deter manufacturers from releasing dangerous or unsafe products for sale to the general public.

Injuries resulting from defective products can cause physical, emotional and financial stress and proving manufacturer liability can be difficult. If you believe you have been injured by a defective product, you need an experienced personal injury attorney to assess your case. At the Law Office of Jeremy Rosenthal, our qualified personal injury lawyers have experience representing vaginal mesh implant victims as well as all other personal injury victims, and we will fight for the compensation you deserve. If you or a loved one has suffered from any mesh implant complications or side effects, we believe you should be able to recover compensation for medical bills, pain and suffering, time off from work and other damages related to use of this dangerous medical device. We are here to help you!

Call us today for a free consultation at at (303) 825 – 2223, or visit us online.

About the Author

Jeremy Rosenthal

Attorney Jeremy Rosenthal is dedicated to helping his clients seek just compensation for their injuries regardless of the lengths he has to go to or the distances he may have to travel in order to get it.


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