>> ANNOUNCER:: Over the years, thousands of health complications have been reported following
the implantation of synthetic mesh, including the bladder sling. In 2012, the FDA
reclassified this synthetic mesh from moderate to a high-risk medical device for the
treatment of pelvic organ prolapse. More recently, mini-slings were introduced. Dr.
Hibner explains what complications he's seen with these smaller devices.
>> DR. HIBNER:: I don't know how many of those were placed, and I have no way of telling
whether the rate is different than the patients that have transobturator slings, but
there's definitely patients that still show up with that type of sling. It is true that
those ā€" many slings do not pierce through all the muscles that the older types of
transobturator slings were, but they still attach somehow to the obturator membrane in
order to stay in place. The pain from mini-slings may be as debilitating as with transobturator devices.
>> ANNOUNCER:: Unfortunately, most of these mesh devices were designed to be embedded in the
muscle tissue that are adjacent to vital nerves, which are responsible for mobility,
sexual function and bowel and bladder function. Health complications following mesh
implantation include muscle spasms; nerve damage caused by either compression or
traction, leading to chronic and often severe pain; also dyspareunia, which is pain with
intercourse; bleeding; mesh erosion; and worsening of incontinence, sometimes involving
interstitial cystitis, which is a painful bladder. Dr. Hibner discusses how interstitial
cystitis, or painful bladder, occurs after a mesh implantation.
>> DR. HIBNER:: It is an allodynia of the bladder, so an allodynia ā€" what it means is that
the slightest sensation to the bladder causes pain. So normally the bladder should only
hurt when it's really full. It most likely originates, in my mind and other people's
minds, from some other painful condition somewhere else in the pelvis, where the muscle
spasm happens. And with a muscle spasm, the patients develop obstructive voiding, and
what it means is that the muscles don't relax enough for patients to empty the bladder.
It really becomes, again, another positive feedback loop, where now the bladder becomes
overly sensitive, because it's trying to squeeze the urine out. Now, the problem is when
you have a patient that ā€" let's say you have placed the mesh, and you've caused that
muscle spasm. Then it may lead to that symptom, so that painful-bladder symptom.
>> ANNOUNCER:: Often, treatment of interstitial cystitis involved hydrodistention, which is
filling the bladder with a saline solution.
>> DR. HIBNER:: The hydrodistention actually helps them with a symptom, as long as you treat
it in other ways. So, it is like you have pain from muscle spasm, and you take a muscle
relaxant. It's not really curing your muscle spasm, but it is helping you temporarily
with it. So that's kinda what hydrodistention is. I mean, I think it is still an
important procedure. It's not going to cure that patient's pain, unless the mesh comes out.
>> ANNOUNCER:: Failure of a mesh device can lead to erosion of the bowel and bladder,
severely disrupting their function.
>> DR. HIBNER:: It is a significant problem, because, well, number one, it may cause the
leakage of the content of the bowel or the bladder into the abdominal cavity. It may
cause peritonitis, but it also ā€" by itself it may ā€" is very painful. It requires a
very complicated surgery to repair it and to close the defect. So, yes, it is a
significant, significant surgical problem.
>> ANNOUNCER:: Symptoms of adverse events caused by synthetic mesh sling implantation can
occur immediately after surgery or years later. When implanted, the devices cause scar
tissue and over time are known to shrink over 20 to 30 percent, leading to traction on
adjacent structures, including muscles and nerves. Particularly impacted by mesh-device
shrinkage are the clitoral nerve, the rectal nerve, the pudendal nerve and the obturator nerve.
>> DR. HIBNER:: So not all women develop pain immediately after mesh, and that is very
perfectly explainable. Mesh shrinks over time, so if you actually do the surgery for the
mesh removal, you can actually see how it's fixed to the muscle. There're points in the
muscle where the mesh is fixed. So if you take a piece of mesh, and it's fixed to the
muscle, and then over time it shrinks by 30 percent ā€" and those studies are done. We
know that the mesh shrinks. You will see that with time it is like ā€" maybe it doesn't
pull on the muscle immediately after the placement. It may pull on it few years later.