Women may experience a Pelvic Organ Prolapse (POP) due to childbirth, aging, genetics, or menopause. POP occurs when the muscles and tissue supporting pelvic organs weaken. This allows pelvic organs to press into or protrude from the vagina. Many women receive a transvaginal mesh to provide support and repair weakened tissue involved in the prolapse. While transvaginal mesh devices should heal women, the Avaulta mesh may cause infection and pain in patients.
Our law firm is currently handling lawsuits on behalf of individuals harmed by Avaulta vaginal mesh.
C.R. Bard was a medical device manufacturer headquartered in New Jersey. The company specialized in vascular, urology, and oncology medical technologies. Bard also manufactured and distributed thousands of its transvaginal mesh device, the Avaulta. This transvaginal mesh was implanted through the vagina to reinforce the weakened vaginal wall in instances of pelvic organ prolapse. Sometimes healthcare professionals insert Avaulta mesh to remedy stress urinary incontinence (SUI). SUI is the involuntary leakage of urine during moments of physical activity that stress the abdomen.
The FDA granted 510(k) approval for Bard’s Avaulta mesh. 510(k) approval is often the subject of debate since this fast-track approval does not require the manufacturer to conduct clinical trials. The FDA allows this if there is a similar product already available on the market. However, in 2008, the FDA warned the public that transvaginal mesh patients are at risk of adverse health complications. In this letter, the FDA announced that transvaginal mesh devices, like Auvalta mesh, do not improve POP outcomes more than traditional treatments.
In 2011, the FDA revealed it is not rare for patients with transvaginal mesh devices, like Auvalta mesh, to experience health complications. The FDA reported the most frequently reported transvaginal mesh complications from 2008–2010, which included:
Many women resorted to revision surgery to remove the Auvaulta mesh to relieve the painful complications. Although this revision surgery resulted in SUI and POP recurrences, the very issues the Avaulta mesh was designed to resolve. Countless individuals have endured physical and mental anguish due to Avaulta mesh complications. These claimants allege that C.R. Bard is responsible for a defective design that led many women to receive hazardous Avaulta mesh devices. Furthermore, lawsuits argue that C.R. Bard failed to adequately test the Avaulta mesh for potential hazards or side effects before marketing it as safe and effective.
Several individuals have filed lawsuits against C.R. Bard for its Avaulta mesh products. In 2012, a couple received $5.5 million after they accused C.R. Bard of irreversible damages caused by its Avaulta mesh. Additionally, in 2021, a jury awarded $68 million to a woman who suffered tissue damage and chronic pain after receiving an Avaulta mesh.
If a defective Avaulta vaginal mesh harmed you or a loved one, you may qualify for an Avaulta mesh lawsuit. An Avaulta mesh lawyer can help you recover compensation for:
In 2012, C.R. Bard quietly removed its Avaulta mesh from the market. The decision came after the FDA announced it would require three-year post-approval monitoring studies for all transvaginal mesh products. Individuals allege Bard refused to conduct a study because the company understood the risks and dangers associated with its Avaulta mesh. The Avaulta mesh affected the physical health, emotional wellbeing, and relationships of countless women. If you are a victim of the Avaulta mesh, reach out today to discuss your story with one of our Avaulta mesh lawyers.
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 525-3529 or submit an inquiry on this page.
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