In a move that could be considered too little and too late – Boston Scientific is updating the warning on its pelvic mesh products. Boston Scientific, based in Marlborough Mass., has added new precautions to its Directions for Use, the label that accompanies the permanent polypropylene implants read by doctors.
Used to hold up a urethra, bladder or sagging pelvic organs, the new language now says that “regardless of the route of delivery” the pelvic meshes have been associated with “erosion.”
Erosion has been the most common complication of pelvic mesh and know about for decades, so this is not news to the women who have filed in excess of 21,000 product liability cases in federal court in West Virginia.
Those defective product trials are full of cases of women suffering from erosion of the bladder, vagina, urethra, ureter and bowel, no matter how it’s placed.
Adverse events have been updated too. They include perforation or laceration of vessels, bladder, nerves, urethra or bowel that can occur during placement of the mesh through the vagina. Also listed as additional adverse events are scarring, scar contracture and ongoing chronic pain, an update from just the word “pain.”
These conditions may become permanent, says the press release.
The company has expanded those for whom the medical devices are contraindicated, in other words, patients the device shouldn’t be used in. That includes factors such as diabetes, smokers, age, pelvic floor radiation exposure, impaired wound healing, either from diabetes or steroid use, and an active infection near the surgical site.
What we have seen in mesh trials is evidence that mesh is not inert while in the body. Once placed, pelvic mesh incites an inflammatory and foreign body response. Scar tissue forms and contracts oftentimes encapsulating nerves. This explains why so many women have pain that shoots down their leg.
The Directions for Use now say “scarring/scar contracture” can occur.
Perforating the colon can be a particular danger of vaginal mesh. If used in the posterior space between the back of the vagina and the colon, polypropylene mesh can erode into the colon causing a septic condition. Sepsis is a severe and quick moving bacterial infection of the blood which originates in fecal material.
Many deaths have been attributed to sepsis that originated with perforation of the colon by mesh in both hernia mesh patients and women with pelvic mesh.
Now the instructions add “perforation or laceration of vessels, nerves, bladder, urethra or bowel may occur during placement.” This is not entirely accurate because with time erosion into the bowel can occur.
Boston Scientific continues to sell the Advantage and Advantage Fit System, the Lynx System, Obtryx and Obtryx II and the Solyx incontinence mesh placed through the obturator space. Transobturator placement has already been found to be a defective design in the product liability trial of another manufacturer.
These devices are called Mid-Urethral Sling Systems, sometimes referred to as the innocuously named “tape” or “sling.”
The updated warnings also apply to the pelvic organ prolapse (POP) devices the company still sells including Uphold LITE, Pinnacle LITE and Upsylon Mesh Kit.
Additions to POP mesh warn that “mesh is considered a permanent implant. Removal of mesh or correction of mesh-related complications may involve multiple surgeries.” Also warning is that the complete removal of mesh may not be possible and may result in additional surgeries.
We know from experience that repeated surgeries to try and remove mesh are not uncommon.
In its press release, Boston Scientific stresses none of these products are recalled and you need not return the product to the company.
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