Despite the Food and Drug Administration’s (FDA) ordering of transvaginal mesh products off the market, the move came far too late for many women already injured – some irreversibly so – from these unsafe medical devices.
What is pelvic organ prolapse and how does it happen?
Pelvic organ prolapse (POP) is a disorder in which one or more of the pelvic organs drop from their normal position in the body. Organs in this area are prone to prolapse; one prolapsed organ in that area (e.g. the rectum, urethra, bladder, uterus) can cause the others around it to sag or bulge.
POP can cause a variety of medical complications. Although pelvic organ prolapse is hardly ever deadly, it can cause issues like a urethral (the tube that carries urine) kink, which can result in difficulty urinating, pain during sex, urinary tract infections (or UTIs), kidney damage, and bowel control problems, or fecal incontinence.
One (now formerly) popular treatment option for pelvic organ prolapse was surgical placement of transvaginal mesh devices. Transvaginal mesh is a net-like medical material used by doctors to repair or support weakened tissues surrounding a prolapsed organ(s).
In early 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair to stop immediately selling and distributing their products. The agency has classified transvaginal mesh as a class III, or high-risk, medical device.
Transvaginal mesh devices are now considered high-risk because they can cause an array of serious health complications. The FDA has received more than a thousand reports of post-surgical complications linked to transvaginal mesh implantation, like:
In its statement, the FDA says they have “not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks.” The agency warns women who received transvaginal mesh for POP to immediately contact a health care provider if they experience any of the following symptoms: pain with sex, pelvic or groin pain, and persistent vaginal bleeding or discharge.
In 2017, a 42-year-old Canadian woman died from sepsis after going through years of recurring infections linked to her transvaginal mesh implant; she is thought to be the first fatality linked to a transvaginal mesh product. Some women in online transvaginal mesh forums say they would rather kill themselves than live with the physical pain they experience every day – and hundreds more recount near-death experiences because of life-threatening medical complications.
Although some women are lucky enough to have not experienced serious complications, too many others have. This is largely in part to manufacturers failing to ensure that their products are safe before releasing them on the market. If you have experienced complications from a transvaginal mesh product, someone at our firm can help. Please contact us directly.
If you or a loved one has been injured, we are happy to answer your questions and have one of Philadelphia product liability lawyers review your case for free. Galfand Berger has offices located in Philadelphia, Bethlehem, Lancaster, and Reading, and we serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or complete our online contact form.