Product News and Recalls

Doctor: No advantage to dangerous implant

In testimony before the U.S. Food and Drug Administration, Dr. Michael Carome called for a ban on all vaginal mesh products, on the grounds that they have no advantages over other forms of treatment, yet cause a host of severe health problems.

Mesh implants are used to treat urinary incontinence and pelvic organ prolapse – a condition that results when weakened muscles provide inadequate support for internal organs.

Carome, who is deputy director of the Health Research Group for nonprofit public health advocacy organization Public Citizen, makes a comparison in his testimony between the surgical procedures commonly used to treat pelvic organ prolapse, and the implantation of a mesh device.

As Carome points out, most women with the condition have no symptoms and thus don’t require any treatment. For women who do require treatment, the goal is to relieve symptoms.

Carome said a review of scientific literature reveals that repair with mesh appears to result in less prolapse being detected on pelvic examination, compared to surgery that doesn’t use the mesh implants. But the mesh doesn’t provide any better outcomes in terms of relieving symptoms or providing a better quality of life, which are the real point of treatment in the first place.

And in return for receiving a procedure that offers no real advantage in relieving symptoms, Carome testified, women put themselves at risk of mesh erosion, severe pain, incontinence, organ perforation, and infections.

See the testimony here: http://www.citizen.org/hrg1969