For Linda Gross, of Watertown, S.D., a simple surgery to correct pelvic organ prolapse (POP) became a living nightmare after she experienced several, serious complications.
Like Gross, many women suffer from a condition called pelvic organ prolapse, or POP. POP occurs when the muscles and ligaments that hold the pelvic organs in place become weakened and stretched causing the organs to bulge- or descend into the vagina. This condition is most commonly caused by childbirth or a hysterectomy, or surgical removal of the uterus. The organs most affected are the bladder, small bowel, rectum, uterus, and vagina.
The condition is usually treated by inserting a synthetic mesh that supports the organs and helps to prevent additional prolapse. However, vaginal mesh has been linked to several, serious complications, says the United States Food and Drug Administration. Between 2008 and 2010, the FDA received 1,503 reports of injury, malfunction or death associated with the surgery. These reports represented a five-fold increase from just a few years prior which lead the agency to release a warning in August 2011.
Ever since Gross had the surgery in 2006, she has had urinary complications, constant pain and swelling as her body rejects the implant. She claims that she cannot sit for longer than 20 minutes, cannot have sex with her husband, and she can't be active for more than a few minutes. Twelve additional surgeries have failed to correct her complications.
"It's horrible. There are unknown amounts of the mesh still in me. I have extreme pain. It feels like the inside of my vaginal wall is on fire," Gross says "I wouldn't wish this on anyone."
The FDA is considering pulling the device from the market, pending more safety data. The agency also convened a two-day meeting with outside experts to discuss further regulatory measures.
In the meantime, Gross and 100 other women are suing the makers of the device, Johnson & Johnson's Ethicon, asserting claims of negligence and defective product design. The women are suing for compensatory and punitive damages. Although the company has refused to publically comment, court filings show the company has denied the allegations.
"My experience, I can't change that, but I want other women to understand the dangers of the mesh product," Gross says.
The FDA began warning about the device in 2008, asking surgeons to receive special training on how to correctly implant the device and tell their patients of any complications the agency deemed as rare, but serious.
Author Resource:-
Trans vaginal mesh is a medical device linked to several complications. LegalView connects individuals to personal injury attorneys to handle these type of cases.
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