For at least a year, several public health advocates have been calling for a CR Bard mesh recall due to erosion issues following surgeries to repair pelvic organ prolapse and stress urinary incontinence. In October 2008, the U.S. Food and Drug Administration (FDA) issued a public health advisory, noting the potential complications of transvaginal mesh. At that time, the agency had already received over 1,000 notifications of complications from nine transvaginal mesh manufacturers. Although complications were initially noted as “rare,” the FDA then updated the advisory in July 2011 and changed its stance, acknowledging that adverse effects are “not rare.”
Women considering transvaginal mesh procedures should monitor media reports about a possible CR Bard mesh recall. Additionally, if you have already been fitted with a mesh device and you suffered from transvaginal mesh complications, Bernstein Liebhard LLP can help you to determine if you have a valid claim and fight to protect your legal rights.
CR Bard Mesh Recall Status
Due to over 4,000 adverse event reports regarding transvaginal mesh implants used for stress urinary incontinence and pelvic organ prolapse repair, the FDA released a second safety communication on July 13, 2011. This document recommended that physicians and patients consider alternative treatment methods for these conditions and called for a meeting of its advisory panel to determine whether these products should be recalled and completely removed from the public market.
After meeting in September 2011, the advisory panel subsequently announced its support of a requirement proposed by the FDA. This proposal would require that all new mesh devices be subject to comprehensive safety testing prior to receiving FDA approval. However, the FDA is still reviewing scientific data pertaining to mesh use and plans to issue a separate report.
Still, although the proposal would ensure that safer devices are released in the future, it does not address concerns that have arisen due to products already on the market. Patients have suffered from adverse and sometimes life-threatening complications from transvaginal mesh devices manufactured by CR Bard, American Medical Systems, Coloplast, Ethicon and Boston Scientific.
Sales of Some Avaulta Products Suspended; CR Bard Fails to Issue Mesh Recall
In July 2012, CR Bard suspended sales of some Avaulta products in response to the FDA’s demand that it and other manufacturers conduct additional testing on their products. The products affected by this decision are:
- Avaulta Plus Biosynthetic Support System
- Avaulta Solo Biosynthetic Support System
- Avaulta Solo Synthetic Support System
- Avaulta Biosynthetic Support System
Patients Report Vaginal Mesh Complications
The mesh has been shown to cause several adverse side effects including painful sexual intercourse, bleeding, urinary tract issues and infections. Some patients have experienced mesh protruding from the soft tissues in their bodies while others have learned that the organs located near the site of insertion have been damaged by the mesh. The most common complication involves erosion of the mesh, which typically occurs between four and 16 months after the procedure.
Patients who develop complications usually require removal of the mesh through a vaginal incision. This process may require multiple procedures, after which the prolapse must still be corrected. Those suffering from stress urinary incontinence are treated in a similar manner, often followed by the re-sewing of tissues in the vagina. If erosion only exists in a small area, a physician may apply a topical vaginal cream containing estrogen.
Those Injured Have the Right to Sue
Those who have allegedly been injured due to a transvaginal mesh implant may feel as though they are not entitled to recover damages while fitted with devices that have not yet been recalled. On the contrary, tens of thousands of claims have been filed in state and federal courts over injuries allegedly caused by surgical mesh devices used to treat stress urinary incontinence and pelvic organ prolapse.
With an understanding of mesh complications and the factors that could result in a mesh recall, those who are considering these surgeries will be better able to make informed decisions about their healthcare. However, women who have already suffered injuries should consider seeking legal counsel to recover compensation for medical expenses, lost wages and pain and suffering, among other damages.
Victims are Urged to Seek Legal Counsel, Time is Running Out
If you or a woman you love are a victim of complications and you would like to learn more about filing a claim for compensation in the absence of a CR Bard mesh recall, we urge you to contact Bernstein Liebhard LLP at your earliest convenience. Our experienced attorneys will evaluate your case and file an individual lawsuit on your behalf if you have a valid claim. Simply fill out our online form or call us at (888) 217-3033, and someone from our legal team will be in touch with you shortly.