FDA Warns of Serious Injuries from Bladder Mesh Device Erosion

In over three years, between 2005 and 2007, a significant

number of complaints pertaining to pelvic mesh devices

have been submitted to the United States Food and Drug

Administration, explaining that adverse events from mesh

devices have surpassed 1,000, according to online media

reports. Subsequently, the agency instigated warnings

over safety problems surrounding vagina or bladder mesh

devices when used to repair pelvic organ prolapse (POP)

and stress urinary incontinence (SUI), through a Public

Health Notification that was released in 2008. The safety alert, which was sent out to notify both the

medical community and the public, warns of the possible medical consequences that may result from

these potential risks, and provides suggestions on how to abate them. Since then, the number of

adverse-event reports submitted to the agency has never stopped to grow, reaching up to 2,874 reports

between 2008 through 2010 and inciting a series of bladder mesh legal actions from women who have

had a first-hand experience of these mishaps.

Pelvic meshes are medical devices are sometimes used in surgery, designed as a hammock-like support

to areas impacted by POP (descent or dropping of pelvic organs), and SUI (urinary problem) in most

women, according to medical experts. Although they may be implanted through an incision to the

abdomen, most surgeons prefer a less invasive technique of placing them through the vagina. The

implantation of surgical mesh through the vagina, specifically for POP repair, however, has been

reportedly associated with risk of adverse events at some point after surgery.

As a result, the US FDA released another warning, an updated Safety Communication in July 2011. The

most prominently reported complication to stem from these medical devices is mesh erosion – an

adverse event that has been linked to a string of serious injuries in women including urinary problems,

infections, extreme pelvic or vaginal pain, bleeding, painful sexual intercourse, as well as emotional

damage. The pain and discomfort brought about by the erosion or protrusion of the device to nearby

organs, as well as vaginal scarring, have been reported to significantly diminish the quality of life in

patients. Although mesh problems have been found to develop in one month, approximately 10 percent

of 12,000 study participants have also been seen to suffer from the notable post-surgery complication

after a year, according to a previously conducted analysis.

Some of the aforementioned complications have been reported to require multiple repeat surgeries,

and even longer hospitalization, medical experts say. With this in mind, the FDA advises women to take

a proactive and cautious mindset by discussing the potential risks associated with bladder mesh

implants for the treatment of POP and SUI prior to surgery. Relevant information found at

bladdermeshlawsuit.us could also be a great reference to people concerned and interested.