A pair of new studies with mixed results suggests that removal
of vaginal mesh -- a device implanted to help support a woman's pelvic organs –
may not improve side effects such as pain and incontinence related to the
device.
The findings, reported Monday
at the American Urological Association's annual meeting, come at a time of
growing safety concerns over vaginal mesh devices. Last month, the U.S. Food
and Drug Administration (FDA) said it will require stricter oversight of the
products -- specifically, as they are used to treat pelvic organ prolapse. The
FDA now classifies these devices as "high-risk."
Unbelievably, the implants are
still in use, and the recent FDA action applies only to vaginal mesh used for
pelvic organ prolapse -- and not the other uses for mesh implants. Manufacturers
will have to provide extensive safety data to the agency before it will approve
future mesh devices for sale, unlike those that injured thousands of women,
which were approved based on their similarity to mesh that has been used for
decades to repair abdominal hernias.
In pelvic organ prolapse, the
structures supporting the bladder, uterus and rectum weaken and stretch. The
organs may drop from their normal position and protrude into the vagina, which
can cause pelvic pain, discomfort during sex, and problems with urination and bowl
movements.
Some women with pelvic organ
prolapse eventually need surgery to reposition and secure the pelvic organs. Vaginal
mesh implants were marketed to give extra support to the organs after
corrective surgery.
However, the FDA began
receiving reports of problems linked to the devices. There were cases where the
mesh eroded, and women suffered infections, bleeding or pain.
The study followed 123 women who had surgery to remove
either a mesh device or another synthetic device called suburethral tape. The
results from this study was mostly good. Most of the women -- including 67
percent of those with the mesh device -- became pain-free after surgery. And on
average, patients' pain ratings were much lower two to three years after
surgery versus before the surgery.
The second study, by researchers at the University of
California, Los Angeles, had less-positive results. It surveyed 214 women roughly
three years after their mesh implants were surgically removed. Post-surgery,
many women continued to have problems, the study found. Although two-thirds of
the women said they had no pain or only mild symptoms, the rest had moderate to
severe pain. Twenty-eight percent said they suffered from incontinence at least
once a day, and half had pain during sex, according to the study.
There are a multitude of manufacturers of these products.
As such, litigation over the various types of mesh implants have been going on
for a few years. The results of trials that have occurred have been mixed. Last
year, a major victory was achieved for the victims with a huge punitive damage
judgment. See my previous blog post on that story.
Earlier this year however, U.S. District Judge Joseph
Goodwin in Charleston, West Virginia, granted judgment for Johnson & Johnson
on Carolyn Lewis’s claims that a TVT Retropubic sling implanted to treat
incontinence was improperly designed, according to court records.
J&J is facing more than
12,000 federal-court claims that the TVT Retropubic slings and its other
vaginal-mesh inserts degraded over time, causing pain and injuries. The cases
have been consolidated before Goodwin for pretrial information exchanges.
Lewis’s case was the first sling suit to go to trial. More than a million women
have had the slings inserted since the device was approved in 1998.
Another
manufacturer, American Medical Systems (AMS) and its parent company, Endo
International Plc, announced an $830
million offer to settle approximately 20,000 pending vaginal mesh lawsuits.
News of the settlement was reported on May 1, 2014.
The
AMS settlement will resolve most of the lawsuits filed by women who allege they
have suffered injuries after being implanted with the company’s Apogee,
Perigee, and Elevate mesh devices that were meant to alleviate symptoms of
pelvic organ prolapse and stress urinary incontinence. Each claimant will
receive approximately $40,000, based on the total amount of the settlement.
Many of the lawsuits have been consolidated into the MDL in front of Judge Goodwin.
However, Endo is facing a number of lawsuits filed in various state courts
throughout the country.
