Surgical Mesh Recall

by Steve Fields on July 1st, 2012

According to the FDA, 80,000 women underwent vaginal mesh surgery in 2010 to correct pelvic organ prolapse (POP). Johnson and Johnson announced a surgical mesh recall, which is the first major recall of transvaginnal mesh this year. During the same year, an additional 200,000 women received mesh transvaginally to repair stress urinary incontinence (SUI). Since the 1990s, when vaginal placement was introduced, the procedure has continued to grow in popularity. But there are significant concerns about the safety of the devices. Between 2005 and 2010, the FDA received nearly 4,000 reports of serious vaginal mesh complications experienced by implant recipients.

Many women who have been injured by these devices are motivated to file vaginal mesh lawsuit claims against the products’ manufacturers. But some are uncertain whether doing so is possible if the implant they received has not yet been recalled. We’ll clarify this issue below, and explain the reason it is unnecessary to wait for a vaginal mesh recall.

Transvaginal Mesh Complications Reported By Women

It’s useful to be familiar with the types of injuries mesh recipients have suffered over the years. While the FDA has confirmed receiving thousands of adverse event reports, it is likely many women suffer without reporting their injuries. Additionally, many more will develop complications stemming from these implants in the months and years to come.

The FDA has noted that the most commonly-reported injury has been mesh erosion. This is a problem in which the device begins to move through the vaginal tissue. Its migration often results in severe pain. Erosion also causes bleeding and leads to vaginal infections that can spread through the urinary tract. Some women have complained that their mesh implants have eroded so far that a portion of them can be seen in the vaginal canal.

Contraction of the device, accompanied by vaginal shortening, have also been reported to the FDA. This too causes severe pain, often to the point that it becomes debilitating.

Many mesh recipients have experienced pain during sexual intercourse. The pain often stems from erosion or contraction of the implant.

Other reported injuries include urinary dysfunction, vaginal scarring and drainage, as well as issues related to the nerves that control the muscles. Some women have suffered perforations of their bowels and bladders during the procedure to install the device.

The above complications are among the reasons so many women have considered filing pelvic mesh lawsuit claims. But there is an additional point, which we’ll describe below, that further increases their motivation.

Past Vaginal Mesh Recall For A Defective Implant

In 1999, a transvaginal mesh recall was issued for Boston Scientific’s ProteGen Sling, a device designed to correct SUI. Thousands of women had complained about serious complications. Leading up to the recall, 27 percent of surgeons who had previously been installing the implant had abandoned it. The ProteGen Sling, branded as a defective device, was soon pulled from the market.

In October 2011, Bloomberg reported that some of the mesh implants currently sold by Johnson & Johnson were approved by the FDA based on their similarity to the ProteGen Sling. Even worse, some of them were now the subject of vaginal mesh lawsuits. In short, although a bladder sling recall has not yet been issued for many of the devices currently being sold, there is evidence those devices might be defective.

Can A Transvaginal Mesh Lawsuit Be Filed Without A Recall?

Hundreds of individual pelvic mesh lawsuits have already been filed against manufacturers that have thus far refused to issue a surgical mesh recall. To demonstrate, Bloomberg reported in March 2012 that over 500 cases were pending against a single implant made by Johnson & Johnson.

A recall does help a case since it demonstrates a product (or medication) is unsafe or flawed. It may also imply a manufacturer was aware of the problems its implant or drug caused patients, and chose not to alert them. But it is unnecessary to wait for a recall to be issued before filing a claim.

If you received a vaginal mesh implant and have suffered any of the complications described earlier, you may be able to recover compensation for your injuries. Contact a surgical mesh recall lawyer to discuss your legal options.

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