A transvaginal mesh product used to treat stress urinary incontinence and pelvic organ prolapse, the Avaulta implants manufactured by CR Bard have been linked to several side effects such as pelvic pain, painful intercourse and infection. The U.S. Food and Drug Administration first alerted consumers to the Avaulta mesh complications in 2008 when it released a warning about the problems with transvaginal mesh products. The agency has since found that patients undergoing pelvic organ prolapse repair procedures using a transvaginal mesh device have a higher risk of complications than those who undergo other surgical options. Since the FDA’s warning was released, several lawsuits have been filed, alleging that CR Bard failed to properly design its product and failed to adequately inform physicians and patients of its risks.
Have you experienced Avaulta mesh complications or side effects? Please call Bernstein Liebhard LLP at (888) 217-3033 or fill out our free case review form today to speak with a member of our legal staff. We will help you to determine if you have a valid claim and will fight to ensure you receive the compensation to which you may be entitled.
Avaulta Mesh Complications Reported to FDA
The FDA announced in July 2011 that the placement of transvaginal mesh devices including the Avaulta Biosynthetic, Avaulta Solo or Avaulta Plus may place patients at an increased risk of experiencing complications than patients who choose other options. However, this was not the FDA’s first announcement pertaining to transvaginal mesh complications as it had issued a warning in October 2008 stating that patients implanted with mesh products, including the Avaulta surgical mesh, were more likely to suffer from side effects. At this time, the agency had reportedly received over 1,000 adverse event reports from women claiming that the implants caused complications including:
- Urinary problems
- Mesh erosion
- Vaginal scarring
- Bladder, bowel and blood vessel perforation
- Pain including pain during intercourse
Other Avaulta mesh complications include pelvic pain, permanent nerve damage, rectal problems and deformation of vaginal tissues. These side effects may be treated by partially or completely removing the device. However, there is a high chance that stress urinary incontinence or pelvic organ prolapse will return, even though these are the conditions that the mesh is intended to treat. Pelvic reconstruction, colostomies and bladder stems are among the other available treatments for Avaulta mesh complications.
Litigation Surrounding the Avaulta Transvaginal Mesh Products
Following the FDA’s announcement in 2011 in which the agency reported that it would be implementing a safety panel to determine whether transvaginal mesh products should be recalled, the agency determined that new transvaginal mesh implants would need to be subject to intense post-market trials and studies in order for the manufacturers to accurately and properly conclude whether the products are safe for use.
However, CR Bard allegedly suspended sales of its entire Avaulta line of products, including the Avaulta Solo Synthetic Support System, the Avaulta Solo Biosynthetic Support System, the Avaulta Biosynthetic Support System and the Avaulta Plus Biosynthetic Support System. Following the sales suspension, more patients continued to come forward in an effort to file claims against the manufacturer and seek compensation for their injuries.
CR Bard has settled two out of the three bellwether trials in transvaginal mesh lawsuits brought against the company in favor of the plaintiffs. The third case in the litigation was dismissed, and the fourth has been postponed. Avaulta mesh complications can cause permanent deformities and physical damage. In addition to physical pain from corrective surgeries and side effects, women may also experience psychological and self-esteem issues.
Eligible Patients Should Consider Filing an Avaulta Claim
Patients who are experiencing Avaulta mesh complications may be able to file a transvaginal mesh lawsuit to recover financial compensation. However, in order to be eligible to bring a claim against the manufacturer, patients must have been fitted with an Avaulta mesh device manufactured by CR Bard and inserted prior to July 13, 2011. Additionally, eligible plaintiffs must have underwent a subsequent revision or removal procedure or received a diagnosis from their doctors that such a procedure is necessary.
Our Attorneys Can Help Victims Seek Compensation for Their Injuries
If you or a loved one have experienced Avaulta mesh complications and you would like to learn more about your legal rights, the attorneys at Bernstein Liebhard LLP are here to assist you. We will answer your questions to the best of our ability and provide you with a free, no-obligation case review to help you to determine if you have a valid claim. Please fill out the case evaluation form on this page or call us at (888) 217-3033 to begin the process of recovering compensation for your injuries.