By Independent Staff Writer
Surgical Procedures Using Mesh
Mesh
has been widely used in a variety of surgeries since the 1950’s, and
was originally approved for use in abdominal hernia surgery. Surgeons
began altering the size and shape of the mesh devices, using them in
women’s surgeries for pelvic organ prolapse and stress urinary
incontinence. It was not until 1996 that the mesh was approved
specifically for SUI surgeries and 2002 when it was approved for POP
surgeries.
Mesh Complications
The
FDA issued their first public health alert in 2008 detailing the
potentially serious complications associated with the transvaginal
placement of surgical mesh when used to repair pelvic organ prolapse or
stress urinary incontinence. The agency then updated the original
warnings stating that mesh complications in transvaginal repair of
pelvic organ prolapse were actually not all that rare. They continued
the warning by stating that when compared to traditional, non-mesh
repairs for pelvic organ prolapse, there are no apparent benefits to
using mesh.
To
date, the FDA has received as many as 4,000 reports of serious
complications associated with the mesh implant, particularly when used
in the transvaginal repair of pelvic organ prolapse. These reported
complications cover the period from January, 2005 through December,
2010, with almost three-fourths of those in the past three years. Many
believe the numbers will continue to climb; a 2009 review in the
International Urogynecology Journal stated the complication rate from
use of vaginal mesh was from 7%-25% with those who smoked increasing
that already high risk of complications as much as three times.
Clinical Trial Stopped
Following
the FDA’s warnings, a 2010 clinical trial which compared traditional
surgical procedures used in repairing pelvic organ prolapse to
transvaginal mesh procedures was halted before completion due to
complications in over 15% of the patients whose surgery included mesh.
The primary complication was mesh erosion, a serious and even
potentially fatal medical injury which typically requires one or more
surgeries to correct and repair. Regarding this study one of the lead
authors of the report stated that in the end not only were there more
complications, but the mesh didn’t prove to work any better than
traditional surgery.
Is Inappropriate Selection of Patients an Issue in Mesh Damages?
Some
believe that one of the primary problems in the mesh controversy is the
criteria used to select patients for the transvaginal mesh surgery
which repairs pelvic organ prolapse. Because
the mesh device seemed so promising for women suffering from pelvic
organ prolapse it may have been inappropriately used for younger, active
women who could have received greater benefits from alternative types
of non-vaginal surgery. Mesh surgeries are more appropriate for use in
older, less sexually active women who either cannot undergo abdominal
surgery or who has suffered a recurrent prolapse after a past surgery.
Approval for J & J Mesh Based on Recalled Device
The
2008 FDA warning regarding complications associated with transvaginal
placement of mesh included specifics regarding the Bard Avaulta mesh
product. C.R. Bard, Inc., the makers of the Bard Avaulta mesh, sent out a
recall of the mesh in 2005, urging physicians to stop using specific
versions of the product which could potentially break and cut through
internal organs and tissues. The recalled device, known as the Kugel
patch, created a storm of controversy when some Bard executives said
they knew about serious injuries which were potentially caused by the
device. Several fatalities were even believed to be potentially related
to use of the Kugel patch. C.R. Bard maintained they acted responsibly,
however FDA officials found discrepancies and inconsistencies in the
manner in which the devices were traced and analyzed.
Is “Substantially Equivalent” Good Enough?
Even
though the Kugel patch was recalled, Johnson and Johnson subsequently
gained approval for their own mesh device based on its precursor—the
Kugel patch. Approvals of medical devices based on an assessment that
they were “substantially equivalent” to a previously approved device may
be one flaw in the system which has allowed a potentially harmful
device to be implanted in thousands of women. Johnson and Johnson’s
approval from the FDA for their vaginal patch was predicated on the
claim they were substantially similar to the recalled Kugel
patch—presumably without the design flaws. Currently Johnson and Johnson
has at least 600 vaginal mesh lawsuits in the works against the giant
corporation; when you consider that as thousands of women received
vaginal mesh implants in the past year alone, those numbers are expected
to grow.
Transvaginal Mesh Applications Declared “Experimental” in 2007
In
February of 2007—prior to the FDA’s public health alert in 2008—the
American College of Obstetricians and Gynecologists issued a bulletin on
pelvic organ prolapse. This bulletin warned both physicians and their
patients to consider the vaginal mesh procedure to be experimental, and
that patients who consented to the procedure should be made aware of
that fact. They went on to say that because there was both limited data
as well as frequent changes in the mesh products which were being
marketed—particularly regarding the material the mesh was constructed
from—that women considering having the mesh surgery should be aware of
the potential risks and complications.
Some
seven months later, the same group issued a second bulletin with a much
softer warning, and with the word “experimental” mysteriously gone. In
this bulletin women were only warned that because of the limited data
and changes in marketed products as well as potential mesh erosion,
patients should only consent to surgery with this understanding. Because
“experimental” procedures are rarely covered by insurance, it has been
speculated that the potential of losing large amounts of money resulted
in the change in wording.
Is a Flawed Approval System to Blame for Mesh Complications?
Although
the current FDA approval system has been in place for over three
decades, the Institute of Medicine—for one—believes the government
should abandon this medical device approval system because it offers
little safety assurance for patients. The medical device industry is
currently a $350 billion dollar industry which covers everything from
pacemakers to contact lenses. Although this advice is not binding upon
the FDA, it could prove that Americans want tighter standards for
medical device manufacturers who have benefitted financially from less
safety scrutiny than their peers in the industry. Most new prescription
drugs are required to go through rigorous clinical trials to prove
definitively that patients benefit from the medication—and that there
are no serious side effects. On the flip side, most medical devices,
including mesh, must only show they are similar to a device which is
already on the market. It is only the truly brand new innovations which
are required to undergo safety testing. The FDA defends the system in
place stating they have been working for over a year to make the
approval process for medical devices more predictable and less
bureaucratic—changes which would be scrapped if the entire system is
revamped.
Does the 510(k) Approval System Need an Overhaul?
This
35-year old process, known as the 510(k) process has some wondering if
it really protects Americans to the fullest extent possible. While the
FDA is not in favor of eliminating the procedure, they are open to
proposals for improvement. FDA officials point out that they are already
subject to criticism from manufacturers of medical devices who believe
the agency is too slow in clearing new devices, driving up costs and
even forcing smaller companies out of business. The 510(k) system was
created by Congress in 1976 with a goal of granting quicker approvals to
devices which were substantially similar to medical devices already on
the market.
The
system was originally intended to be a temporary means of
grandfathering in medical devices which had been used for decades
however over time became the standard in launching new medical devices.
Today, nearly 4,000 devices are cleared each year under the present
510(k) system while only around 50 devices are approved under a more
stringent system of human testing. While
the 510(k) system is not considered inherently unsafe, there must be
more safeguards in place to protect patients from harm. Although the FDA
is battling a multi-million dollar lobbying effort by medical device
manufacturers, they may have a stronger position due to the fact that
reports of pain, bleeding and infection with the mesh implants are up
500 percent since 2008.
Class II vs. Class III
Prior to the convening of the September 8th
panel regarding the adverse reports of the transvaginal mesh implant,
the FDA recommended that transvaginal mesh products be reclassified to a
Class III (high risk) rather than their current Class II (moderate
risk). A Class II device is approval under the abbreviated 510(k)
process while a Class III classification would give the FDA stronger
controls over the clinical studies conducted before marketing the
product. Obviously the mesh industry wants to maintain their Class II
status, arguing that additional studies and labeling changes on mesh
implants are sufficient to safeguard the health of women. Re-classifying
the mesh implants as high risk would require them to undergo approval
of manufacturing procedures, inspections of their device plans and a
longer review period.
The
FDA must sort through the dizzying array of opinions and facts
regarding the safety, efficacy and potential reclassification of the
transvaginal mesh implants and must also make critical decisions
regarding further clinical studies prior to making their final
determination. In the meantime a national group of surgeon’s stated the
transvaginal mesh devices should only be used in a limited number of
carefully chosen women, and only by highly trained physicians in the
procedure. While Johnson and Johnson continues to maintain that its
vaginal mesh product is safe, women must become their own health
advocates and make sure they have all the facts before agreeing to a
transvaginal mesh procedure. Women
who have suffered severe complications as a result of a mesh implant
may face multiple surgeries and may never fully recover from the damage
done. As we wait for a decision from the FDA, it is likely that more
women will be coming forward regarding the damage done by a mesh
implant.
