This article will detail the
relative effectiveness of warnings issued by the FDA regarding Urogynecologic
mesh use. According to the article, An
Appraisal of the Food and Drug Administration Warning on Urogynecologic
Surgical Mesh, published in Current Urology Reports (2012, 13:231-239)
manufacturers market surgical mesh kits with a goal of increasing speed and
ease of placement. The FDA reports over the past few years have sought to increase
the awareness of the potential risks of surgical mesh when used in a
transvaginal surgical procedure despite manufacturer’s claims.
More and more often reports
are coming out which emphasize the fact that surgeons who use these mesh kits must have specialized training which
enables them to “recognize and manage the
complications of surgical mesh implants.” Governmental regulation of these
mesh devices has also come under fire; while there are many different agencies
in charge of regulation and reporting, women have nevertheless been harmed by transvaginally
placed mesh implants.
Medwatch Event Reporting Program
The Current Urology Reports
article states that, within the FDA the Center for Devices and Radiologic
Health “approves and collects data on the
safety/efficacy of medical devices in the United States.” Medwatch, the
FDA’s current safety and adverse event reporting program gathers information on
medical devices and drugs from health professionals, hospitals, consumers and
nursing homes. Any death or serious injury which is related to a medical device
or drug must be reported to the FDA as well as to the manufacturer of the
device or drug.
Limitations of Existing Databases
The existing databases have
limitations; many patient complications are seen in referral centers and the
surgeons who performed the initial surgeries are unlikely to be the follow-up
physician when complications arise. Because surgeons are unlikely to receive
feedback anytime soon after the surgery it is nearly impossible for them to
improve surgical techniques. According to the article in Current Urology
Reports, a reporting program with significant improvements would “demand a tremendous amount of oversight in
matters as simple as prevention of duplicates and as complex as the enforcement
of mandatory reporting.”
The Difficulties in Defining Successful Treatment
Defining successful treatment
for pelvic organ prolapse is extremely difficult based on the fact that
prolapse symptoms are extremely variable, the degree of prolapse may not
correlate with symptoms reported, there are a wide variety of surgical
techniques in the repair of pelvic organ prolapse, and the data on these
outcomes are heterogeneous. Improvement of quality of life scores were compared
between patients whose surgeons considered the surgery an “anatomical success” and patients who had recurrent prolapse and “no significant difference was found.” It
is believed that long-term studies which specifically address the stability of
transvaginally placed mesh will shed some light on early failures and
complications experienced by recipients of surgical mesh.
The article in Current Urology
Reports states that, according to Abed et al, the risk factors for mesh
complications appear to include a hysterectomy done at the same time as the POP
surgery, the surgeon’s use of a “T” shaped vaginal incision, the level of
surgical experience, the age of the patient, and any history on the part of the
patient for tobacco use or diabetes. The FDA recommends that patients be
presented with a written copy of potential risks involved. The conclusion
appears to be that not enough evidence exists to either warrant the removal of
surgical mesh or to support the use of surgical mesh used transvaginally in POP
procedures. A Drug Watch article dated October 16, 2012 states that a new
survey shows that “surgeons who
specialize in urogynecology are using transvaginal mesh less to repair
recurring pelvic organ prolapse.” This seems to bear out the fact that the
FDA warnings are indeed having some effect. This article detailed the effectiveness of FDA
warnings on urogynecologic mesh.
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