The U.S. Food and Drug Administration (FDA) issued a public health notification in October 2008 amid mounting reports of complications due to CR Bard’s Avaulta transvaginal mesh implant devices. The agency had allegedly received more than 1,000 reports of injuries and adverse side effects from patients who had been fitted with mesh implants produced by nine manufacturers, including CR Bard. Although the FDA did not issue an Avaulta mesh recall at that time, it later announced in July 2011 that transvaginal mesh complications are “not rare” and that patients should consider alternative forms of treatment prior to choosing a mesh implant to relieve symptoms of stress urinary incontinence and pelvic organ prolapse.
If you would like to learn more about the Avaulta mesh recall or if you have suffered from adverse side effects or complications that resulted in the need for a revision or removal procedure of your Avaulta transvaginal mesh implant, the attorneys at Bernstein Liebhard LLP are currently offering no-obligation consultations, free of charge. Contact us today to learn more about your legal rights and whether you are eligible to file a claim.
CR Bard Fails to Issue Avaulta Mesh Recall
Following the FDA’s issuance of a new warning in July 2011, CR Bard suspended sales of several Avaulta implants. The FDA had previously announced that it would be forming an advisory panel in September 2011 to decide whether or not transvaginal mesh implants would need to be recalled, and the committee determined that, while a recall was not necessary, it would propose that all new devices be subject to safety testing before the FDA would grant approval of the implants. After learning of this, CR Bard made the decision to suspend sales of its Avaulta Biosynthetic Support System, Avaulta Plus Biosynthetic Support System, Avaulta Solo Synthetic Support System and Avaulta Solo Biosynthetic Support System. However, this decision did not affect those implants that were already in circulation and had previously been implanted in patients.
Patients Report Side Effects Amid Recall
According to plaintiffs filing claims against CR Bard and adverse event reports submitted to the FDA by patients fitted with Avaulta transvaginal mesh implants, the devices may cause bleeding, infections, urinary tract issues and painful sexual intercourse. Additionally, the implants also have the potential to erode into the vaginal walls or perforate or damage nearby organs.
Revision procedures or removal surgeries may be required if a patient suffers from complications. These processes can be costly, painful and not always effective on the first try. As a result, plaintiffs are requesting compensation to pay for the added expense of these medical treatments as well as to cover the emotional distress, pain and suffering and loss of income that they are likely to incur as a result of their injuries.
Victims May File Claims and Recover Compensation for Injuries
Eligible patients who received an Avaulta mesh implant prior to July 13, 2011 and who subsequently underwent a revision procedure to remove the device after experiencing complications may be entitled to file for damages for their conditions. Although the Avaulta product line has been pulled from the market, patients who had been fitted with the implants prior to the recall as well as those who still suffer from complications may be eligible to hold the manufacturer accountable for their injuries if it can be proven that CR Bard knew, or should have known, about the risks of its products and failed to adequately warn the medical and public communities of these alleged dangers.
Monetary Damages Available for Patients Who Suffered Complications
If you have been affected by the Avaulta mesh recall, you may have legal recourse. The attorneys at Bernstein Liebhard LLP understand how painful these implants and their complications can be. The last thing patients need is to undergo additional procedures for a surgery that was intended to eliminate their pain the first time. Please fill out the form on this page or call us at (888) 217-3033 for more information if you feel that you have a valid claim and would like to begin the process of recovering compensation for your injuries. We will evaluate your case, free of charge, and work to ensure your legal rights are protected and that you recover the damages to which you may be entitled.