Posts Tagged ‘female pelvic medicine and reconstructive surgery’

IT’S ALL MESHED UP: FDA Decision on Pelvic Prolapse Repair Mesh Sets Back Women’s Health

April 20, 2019

Andrew Siegel MD 4/20/19

This past Tuesday, the U.S. Food and Drug Administration (FDA) ordered the manufacturers of all remaining surgical mesh products for trans-vaginal repair of pelvic organ prolapse (Boston Scientific and Coloplast) to stop selling and distributing their products in the USA, effective immediately. According to the FDA, the manufacturers in their premarket applications failed to provide reasonable assurance that the benefits of the products outweighed their risks, compared with trans-vaginal surgical tissue repair without mesh. The inaccessibility of these products will severely hamper treatment options for many women with pelvic organ prolapse and is a genuine disservice to the female population and a blow to women’s health, which has otherwise made major strides forward in the last few decades.

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Boston Scientific Uphold Lite Mesh

 

Clearly, the issue is NOT the mesh, which is a synthetic material—polypropylene—that has been used safely and effectively for years as a suture material and for virtually all hernia repairs. Rather, the issues are threefold—inappropriate manufacturing company marketing, inexperienced surgeon implanters, and our “ambulance-chasing” financially-motivated legal culture.

For years, the manufacturers of these mesh products—many of which ultimately removed themselves from the mesh business—assertively marketed these mesh products in “weekend” courses to surgeons (who were not surgically trained to perform these procedures).  These inexperienced physicians then became avid mesh implanters and often engendered complications in the patients whom they implanted, setting the scene for law firms to aggressively advertise and seek clients for litigation.

Sadly, there is excellent scientific data to support the safety and efficacy of vaginal mesh when done in properly selected patients by skilled pelvic surgeons. Millions of such vaginal mesh surgeries have been performed successfully with minimal complications by pelvic surgeons with training in a subspecialty of urology and gynecology—female pelvic medicine and reconstructive surgery. This requires several years of specialty fellowship training after completion of urology or gynecology residency and a second board examination in addition to board certification in urology or gynecology, thus most in this subspecialty are dual board certified.

Why mesh in the first place?  Why use a synthetic material when native tissues can be used?  The answer lies in the nature of pelvic organ prolapse.  Analogous to a hernia, pelvic organ prolapse is a weakness in connective tissue support allowing a pelvic organ (often the bladder) to pooch down into the vagina and at times outside the vagina, causing an annoying bulge, pressure and often difficulties with urination. The mesh principle is using a structurally sound material instead of a patient’s defective connective tissues (that has already failed) to rebuild support. If a brick wall collapses because of structural issues, would one use the same bricks to rebuild the wall?  Clearly the answer is no.  This is why polypropylene mesh is used in the vast majority of hernia repairs: hardy structural support is needed to compensate for the native connective tissue defect.

The mesh principle: For anatomic defects, using weakened/defective native tissues for a structural repair often causes failures.

In the properly selected patient operated on with the appropriate surgical technique by the experienced surgeon, the results of vaginal mesh repairs have been extraordinarily gratifying and nothing short of a paradigm shift from the native tissue repair era.  This procedure passes muster and the “MDSW” test—meaning I would readily encourage my mother, daughter, sister or wife to undergo the procedure if the situation called for it.

When performed by a skilled pelvic surgeon, the likelihood of cure or vast improvement is very high.   Meshes are strong, supple and durable and the procedure itself is relatively simple, minimally-invasive and amenable to doing on an outpatient basis.  When patients are seen several years after a mesh repair, their pelvic exams typically reveal restored anatomy with remarkable preservation of vaginal length, axis, caliber and depth.

Meshes act as a scaffold for tissue in-growth and ultimately should become fully incorporated by the body.  I think of the meshes in a similar way to backyard chain-link fences that have in-growth of ivy.  Meshes examined microscopically years after implantation demonstrate a dense growth of blood vessels and collagen in and around the mesh.

When mesh is used for bladder repair, there is rarely any need for trimming of the vaginal wall, which maintains vaginal dimensions as opposed to the native tissue repairs, which often demand some trimming of vaginal wall with alteration of vaginal anatomy.  Another advantage of the mesh repair is that if there is some uterine prolapse accompanying the dropped bladder, the base of the mesh can be anchored to the cervix and thus provide support to the uterus as well as the bladder, potentially avoiding a hysterectomy.

The bottom line is that mesh repairs for pelvic organ prolapse have been revolutionary in terms of the quality and longevity of results—a true game-changer.  They represent a dramatic evolution in the field of female urology and urological gynecology, offering a vast improvement in comparison to the pre-mesh era.

That said, they are not without complications, but the complication rates should be reasonably low under the circumstances of proper patient selection, a skilled and experienced surgeon performing the procedure, proper surgical technique, and proper patient preparation. Three factors are integral to proper mesh integration: mesh factors, patient factors and surgeon factors.

The gold standard mesh is a piece of large-pored, elastic, monofilament polypropylene—any other synthetic can result in integration issues.  This is the standard for sling surgery as well, and time has proved this to be the best synthetic mesh.

Patient considerations are very important as risk factors for integration problems include the following: compromised or poor-quality vaginal tissues; diabetes; patients on steroids; immune-compromised patients; radiated tissues; and tobacco users.

Foremost, a well-trained, experienced surgeon should be the one doing the mesh implantation. It is sensible to check if your surgeon is specialized, and if not, at least has significant clinical experience doing mesh procedures. It is particularly important that the surgeon performing the mesh implant is capable of taking care of any of the small percentage of complications that may arise and are most often quite manageable.

Again, many of the problems that have occurred are not intrinsic to the mesh itself, but are potentially avoidable issues that have to do with either the surgical technique used to implant the mesh or to patient selection.  Rather than addressing these issues, the FDA has chosen to throw out the proverbial “baby with the bath water,” leaving in the wake of this short-sighted decision many female patients who will needlessly suffer.

Wishing you the best of health,

2014-04-23 20:16:29

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Dr. Andrew Siegel is a physician and urological surgeon who is board-certified in urology as well as in female pelvic medicine and reconstructive surgery.  He is an Assistant Clinical Professor of Surgery at the Rutgers-New Jersey Medical School and is a Castle Connolly Top Doctor New York Metro Area, Inside Jersey Top Doctor and Inside Jersey Top Doctor for Women’s Health. His mission is to “bridge the gap” between the public and the medical community. He is a urologist at New Jersey Urology, the largest urology practice in the United States.

Andrew Siegel’s latest book: PROSTATE CANCER 20/20: A Practical Guide to Understanding Management Options for Patients and Their Families

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Video trailer for Prostate Cancer 20/20

Preview of Prostate Cancer 20/20

Andrew Siegel MD Amazon author page

Prostate Cancer 20/20 on Apple iBooks

Dr. Siegel’s other books:

FINDING YOUR OWN FOUNTAIN OF YOUTH: The Essential Guide to Maximizing Health, Wellness, Fitness and Longevity

PROMISCUOUS EATING— Understanding and Ending Our Self-Destructive Relationship with Food

MALE PELVIC FITNESS: Optimizing Sexual and Urinary Health

THE KEGEL FIX: Recharging Female Pelvic, Sexual, and Urinary Health

 

 

 

 

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What The Heck is Urology?

August 24, 2013

Andrew Siegel, MD  Blog #116

“Urology” (uro—urinary tract and logos—study of) is a medical specialty concerned with the study, diagnosis, and treatment of diseases of the urinary tract in females and of the genitourinary tract in males. The organs under the “domain” of urology include the adrenal glands, kidneys, the ureters (tubes connecting the kidneys to the urinary bladder), the urinary bladder and the urethra (the channel that conducts urine from the bladder to the outside).  The male reproductive organs include the testes (i.e., testicles), epididymis (structures above and behind the testicle where sperm mature and are stored), vas deferens (sperm duct), seminal vesicles (the structure that produces the bulk of semen), prostate gland and, of course, the scrotum and penis.  The reproductive and urinary tracts are closely connected, and disorders of one oftentimes affect the other…thus urologists are referred to as  “genitourinary” specialists. Urology involves both medical and surgical strategies to approach a variety of conditions.

Urology has always been on the cutting edge of surgical advancements (no pun intended) and urologists employ minimally invasive technologies including fiber-optic scopes to be able to view the entire inside aspect of the urinary tract, as well as ultrasound, lasers, laparoscopy and robotics.  There is a great deal of overlap in what urologists do with other medical and surgical disciplines, including nephrology (doctors who specialize in medical diseases of the kidney); oncology (cancer specialists); radiation oncologists (radiation cancer specialists); radiology (imaging); gynecology (female specialists); and endocrinology (hormone specialists).

Urologists are the male counterparts to gynecologists and the go-to physicians when it comes to expertise in male pelvic health.  Urologists, in addition to being physicians, are also surgeons who care for serious and potentially life-threatening illnesses, particularly cancers of the genital and urinary tracts.  In terms of new cancer cases per year in American men, prostate cancer is number one accounting for almost 30% of cases; bladder cancer is number four accounting for 6% of cases; and cancer of the kidney and renal pelvis (the inner part of the kidney that collects the urine) are number six accounting for 5% of cases.  Urologists are also the specialists who treat testicular cancer.  Urologists also treat women with kidney and bladder cancer, although the prevalence of these cancers is much less so than in males. 

Very common reasons for a referral to a urologist are the following: blood in the urine, whether it is visible or picked up on a urinalysis done as part of an annual physical; an elevated PSA (Prostate Specific Antigen) or an accelerated increase of PSA over time; prostate enlargement; irregularities of the prostate on examination; urinary difficulties ranging the gamut from urinary incontinence to the inability to urinate (urinary retention).

Urologists manage a variety of non-cancer issues. Kidney stones, which can be extraordinarily painful, keep us very busy, especially in the hot summer months when dehydration (a major risk factor) is more prevalent. Infections are a large part of our practice and can involve the bladder, kidneys, prostate, or the testicles and epididymis.  Urinary infections is one problem that is much more prevalent in women than in men.  Sexual dysfunction is a very prevalent condition that occupies much of the time of the urologist—under this category are problems of erectile dysfunction, problems of ejaculation, and testosterone issues. Urologists treat not only male infertility, but create male infertility when it is desired by performing voluntary male sterilization (vasectomy).   Urologists are responsible for caring for scrotal issues including testicular pain and swelling.   Many referrals are made to urologists for blood in the semen.

Training to become a urologist involves attending 4 years of medical school after college and 1–2 years of general surgery training followed by 4 years of urology residency. Thereafter, many urologists like myself pursue additional sub-specialty training in the form of a fellowship that can last anywhere from 1–3 years.  Urology board certification can be achieved if one graduates from an accredited residency and passes a written exam and an oral exam and has an appropriate log of cases that are reviewed by the board committee.  One must thereafter maintain board certification by participating in continuing medical education and passing a recertification exam every ten years.  Becoming board certified is the equivalent of a lawyer passing the bar exam.

In addition to obtaining board certification in general urology, there are 2 sub-specialties within the scope of urology in which sub-specialty board certification can be obtained—pediatric urology, which is the practice of urology limited to children and female pelvic medicine and reconstructive surgery (FPMRS), which involves female urinary incontinence, pelvic organ prolapse, and other female uro-gynecological issues.  The FPMRS boards were offered for the very first time in June 2013, and I am pleased to announce that I am now board certified in both general urology and FPMRS.  There are approximately 100 or so urologists in the entire country who are board certified in the urology subspecialty of FPMRS.

In terms of the demographics of urology, although urology is largely a male specialty, women have been entering the urological workforce with increasing frequency.  This is because female students now comprise approximately 50% of United States medical school population. There are 10,000 practicing urologists in the USA, of which about 500 are women. Urologists have a median age of 53, so we are not a particularly young specialty. The aging population will demand more urological health services and the Affordable Care Act will result in the dramatic expansion of the number of American citizens with health insurance. These factors combined with the aging of the urological workforce and the contraction due to retirement, all in the face of growing demands, does not augur well for a balance of supply and demand in the forthcoming years.  Hopefully there will be enough of us to provide urological care to those in the population that need it.

Andrew Siegel, M.D.

Author of Promiscuous Eating: Understanding and Ending Our Self-Destructive Relationship with Food: www.promiscuouseating.com

Available on Amazon in Kindle edition

Author of: Male Pelvic Fitness: Optimizing Sexual and Urinary Health, in press and available in e-book and paperback formats in the Autumn 2013.

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