A story in the Spring, 2012, issue of The Trial Lawyer magazine takes a look at the flaws in the federal approval process that allow dangerous transvaginal mesh kits to be implanted in women, with disastrous results.
The article is called “Transvaginal Pelvic Organ Prolapse Kits: The Chronicle of Failure.” It describes a system in which representatives of medical device companies frequent the offices of OB/GYNs and surgeons, urging them to implant medical devices that are inherently unsafe.
According to the report, the procedure is used to treat women whose female pelvic organs have shifted after childbirth, causing urinary incontinence and vaginal discomfort. The condition is not dangerous, and surgical procedures are available to correct it.
But the mesh has a tendency to erode, causing severe pain – particularly during intercourse – and abnormal bleeding. Compounding the problem is the fact that removal requires painful, dangerous surgery that doesn’t entirely remove the devices.
And many of the OB/GYNs who implanted the devices are unable to tell the patients what is happening, because the sales representatives hawking the mesh kits haven’t informed them about the medical complications.
According to the article, the major blame lies with “the failure of the FDA’s duty to protect the public from the dissemination of unnecessary and dangerous medical kits.”
The mesh kits were approved through the federal Food and Drug Administration’s 510(k) process, which allows devices to go on the market without clinical testing based on their “substantial equivalence” to existing products.
The kits have a production price to sales price ratio of about $1,500/$50, which the article describes as the embodiment of medical capitalism.
If you have a vaginal mesh implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a mesh lawyer to discuss your legal rights.