Despite a voluntary recall earlier this year, C.R. Bard’s Avaulta Plus products are showing up for sale on eBay.
The first transvaginal mesh implant was approved for use in 1996 – the ProteGen device. Although Boston Scientific later recalled the device, a loophole in FDA regulations called 510(k) allows similar devices to go through and expedited approval process. Since then, dozens of devices from 6 major manufacturers – Coloplast, Boston Scientific, Johnson & Johnson’s Ethicon division, C.R. Bard, American Medical Systems, and Mentor ObTape – have faced thousands of lawsuits, which have been consolidated in multidistrict litigations (MDLs) against the manufacturers. Transvaginal mesh, which is supposed to be a quick and easy solution to pelvic organ prolapse and stress urinary incontinence, has been found to cause severe pain, tissue degradation, continued organ prolapse, infection, and bleeding.
In July, C.R. Bard voluntarily recalled four of their most popular devices in order to avoid further required clinical trials, which the FDA demanded.
Recent eBay auctions now show transvaginal mesh products in listings. While the devices have been up for auction for some time, the Avaulta Plus mesh products were specifically recalled, raising questions about eBay’s business ethics. However, there is no legal precedent to suggest how eBay should be treated. The transvaginal mesh devices were voluntarily recalled, rather than recalled by the government, it is not illegal to continue to sell the devices.
Transvaginalmeshclaim.com suggests several outcomes. “It is possible that since it was a voluntary recall and the company removed the products from the market to the best of their abilities, nothing will be done. It is also possible that the FDA or governing agencies will ask that C.R. Bard attempts to have these products removed from Ebay because they have been recalled. Another option may be that the FDA requires C.R. Bard to go forward with the post market studies since the products are being marketed and sold, even though it is out of their control. It is also possible that between C.R. Bard and the FDA, Ebay is influenced to prevent recalled products, specifically medical devices that could potentially harm others, from being marketed and sold on their auction site.”
Regardless of the outcome for eBay, transvaginal mesh devices are dangerous. If you or a loved one suffered organ prolapse and had transvaginal mesh implanted, and have since suffered dangerous side effects, you may be entitled to compensation. The attorneys at Strom Law, LLC can help. We offer free, confidential consultations to discuss the facts of your case, so contact us today. 803.252.4800.