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The FDA has proposed to reclassify transvaginal pelvic organ prolapse (POP) repair from a class II (moderate risk) device to a class III (high-risk) device.
The FDA has expressed concern about the safety and effectiveness of the current controls and whether they provide reasonable assurance to patients when the surgical mesh is used.
In additional to the POP class proposal, the FDA is also proposing a class change from a I to a II for urogynecologic surgical mesh instrumentation.
What is Transvaginal Pelvic Organ Prolapse?
Mesh used is a synthetic and porous implant used to treat the prolapse, or “drop,” of the pelvic organs, also called pelvic organ prolapse, or POP. A bladder prolapse is the most common organ problem that is treated with transvaginal mesh.
What are the Transvaginal Mesh Implant Side Effects?
Thousands of women reported experiencing complications after the implant of transvaginal mesh devices. These complications include:
The transvaginal mesh lawyers of Zoll, Kranz & Borgess, LLC advocate the importance of drug and medical device safety for all consumers. Please call an attorney toll-free at (888)841-9623 if you or a loved one has experienced adverse side effects from transvaginal mesh.
Source: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm395192.htm
Michelle is a founding partner of Zoll & Kranz, located in Toledo, Ohio. Michelle has been a plaintiff’s lawyer for the entirety of her practice – over 32 years. She devotes the majority of her time to complex consolidated litigation and class action including advocating for people injured by medical devices, prescription medications, or corporate negligence.
This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at Zoll & Kranz, LLC and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced Ohio injury lawyer, Michelle L. Kranz, you can do so here.
Zoll & Kranz, LLC does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.
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