This article will detail the
original warnings the FDA issued regarding urogynecologic mesh when used in
pelvic organ prolapse surgical applications. According to an article titled An Appraisal of the Food and Drug
Administration Warning on Urogynecologic Surgical Mesh published in Current
Urology Reports (2012 13:231-239), permanent surgical mesh has been used in
various applications for several decades, having been used in the repair of
hernias since the 1950’s.
The FDA’s July 2011 report on
Urogynecologic Surgical Mesh defines surgical mesh as “a metallic or polymeric screen intended to be implanted to reinforce soft
tissue or bone where weakness exists.” Beginning in the 1970’s surgical
mesh made its appearance in abdominal surgeries for pelvic organ prolapse, then
in the 1980’s surgeons began using synthetic slings in the treatment of stress
urinary incontinence. It was not until 1996, however, that the FDA approved a type
of mesh particularly for use in stress urinary incontinence surgical
procedures. Some six years later, in 2002, the Federal Drug Administration
approved surgical mesh as an application for the treatment of pelvic organ
prolapse.
Over one hundred mesh devices
or kits have been approved for pelvic organ prolapse repair although only about
a fifth of those devices are currently being actively marketed. The vaginal
meshes and kits which are used in the United States were approved under the
FDA’s 510(k) process which requires only that a new medical device or drug be
“substantially equivalent” to a device or drug which has already been approved.
As the Current Urology Reports article states, all of the mesh devices used for
repair of pelvic organ prolapse actually gained approval under this program
based on the use of mesh for hernia repair.
Because of the process under
which urogynecologic mesh gained FDA approval, there have been few studies on
the safety or efficacy of surgical mesh used in these applications. Regarding
urogynecologic mesh there have been no submissions of “valid scientific evidence to determine reasonable assurance of safety
and effectiveness,” according to Current Urology Reports. The FDA deems
urogynecologic mesh a Class II device although the agency has proposed that
surgical mesh for this application be changed to Class III status. This change
in status would require Premarket/preapproval manufacturing inspection as well
as post approval studies to gain long-term data and annual reporting to the
FDA. The FDA 2011 report states that “The
FDA’s review of these devices has primarily focused on data supporting the
adequacy of mechanical performance and material safety…bench and/or animal
testing have been used to confirm that engineering specifications are met.”
FDA Public Health Notification
In October of 2008 the first
Public Health Notification from the FDA regarding surgical mesh used in
urogynecologic applications was released. This notification detailed
potentially serious complications associated with the use of transvaginally
placed surgical mesh in the treatment of pelvic organ prolapse and stress
urinary incontinence. At this time over
1000 reports of adverse health effects related to transvaginal mesh were noted
from 2005-2007. The conclusion of this first notification was that while
transvaginal mesh generally resulted in better surgical outcomes, those more
positive outcomes could come at a significant cost to a woman’s future health.
At this time the FDA noted that “serious complications were rare.”
Surgical Procedures Using Transvaginal Mesh
There are several surgical
procedures mentioned by the FDA in their notification regarding the use of
surgical mesh including abdominal sacrocolpopexy, anterior transvaginal pelvic
organ prolapse repair, posterior transvaginal pelvic organ prolapse repair and
vaginal vault suspension, also known as apical repairs. While surgical mesh is
also implemented in the form of slings in stress urinary incontinence repairs,
the FDA focused exclusively on surgical mesh used in transvaginal surgeries for
pelvic organ prolapse. According to Current Urology Reports in 2008, specific techniques were described which were
believed to improve the outcomes of surgical mesh used in transvaginal POP repair.
These techniques included: full thickness vaginal wall dissections, tacking of
apical and distal mesh in order to prevent it from bunching up and avoiding a
hysterectomy at the time the mesh is placed.
Other studies state that a concurrent hysterectomy will actually improve
the durability and overall outcome of a transvaginal mesh repair for POP.
Types of Surgical Mesh Available
There are a variety of meshes
available today including absorbable mesh, biologic mesh and xenografts
although most older types of mesh have been replaced with a soft, porous,
polypropylene mesh which is low weight, large pore with an elasticity between
20 and 35%. Current Urology Reports quotes Chen et al as defining the ideal
implant as being “chemically and physically inert, non-carcinogenic,
mechanically strong, sterile, not physically modified by body tissues, readily
available, inexpensive and have minimal risk of infection and rejection.” A
pretty tall order, it would seem.
Adverse Effects From Mesh
The FDA notes erosion as the
number one adverse report submitted by women with pain and infection taking
second and third places. The list of ten adverse events rounds out with
bleeding, dyspareunia (painful sexual intercourse), organ perforation, urinary
problems, neuromuscular problems, vaginal scarring or shrinkage and recurrence
of prolapse. Additionally, neuro-muscular problems and emotional issues were
noted and of the seven reported deaths associated with POP repair, three were
directly related to mesh placement procedure.
Most women who reported
adverse reactions to surgery which implemented transvaginal mesh noted more
than one negative reaction. This article detailed the original warnings the FDA
issued regarding urogynecologic mesh when used in pelvic organ prolapse
surgical applications.
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