AUGS logo2Mesh Medical Device News Desk, January 14, 2014 ~ The jury has been out on the safety of slings to treat stress urinary incontinence (SUI). When the Food and Drug Administration issued its warning to the public in July 2011 (here) it said essentially that the much larger transvaginal mesh used to treat pelvic organ prolapse (POP) carried more risk than benefits and that complications are not rare.

But the FDA left the door open on slings, used to hold up a sagging urethra and prevent the leakage of urine, which affects about one-third of women at some time in her life.

Just this weeks, the American Urogynecologic Society (AUGS) along with the Society of Urodynamics Female Pelvic Medicine & Urogenital Reconstruction (SUFU) have ended the waiting with a Position Statement (here). Slings are safe and effective it says!

It’s estimated up to one-third of women will experience SUI when they laugh, sneeze or cough. While not a painful condition, exercises such as strengthening the pelvic floor may be an effective treatment.

Since the July 2011 FDA warning, lawyers have publicly advertised their services to represent the thousands of women injured by mesh used to treat POP and SUI. The statement goes on to say, “We are concerned that the multimedia attention has resulted in confusion, fear, and an unbalanced negative perception regarding the midurethral sling s a treatment for SUI.”

Blame the media and lawyers.

This perception is not shared by the medical community say the doctors or “An overwhelming majority of women who have been satisfied with the MUS (midurethral sling).”

Both the FDA and these two professional groups acknowledge that the safety of the multi-incisional slings is not well understood in the long term, though a few studies have tried with a limited population. As recently as 2011, researchers stated “there is a need to demonstrate their longevity and safety profiles, particularly in comparison with traditional and established procedures for  pelvic floor repair”  and “Long-term follow-up comparing TVM with accepted ‘gold standard” procedures such as sacral colpopexy would allow accurate assessment of success with appropriate subjective and objective outcome measures and complication rates.”

Justification for the Position Statement

1. Polypropylene (PP) material is safe and effective as a surgical implant.

The statement says PP has been used in surgical procedures for over five decades (as a thread) or as a knitted material (hernia repair).“As a knitted implant for the surgical treatment of SUI, macroporous, monofilament, light weight polypropylene has demonstrated long term durability, safety, and efficacy up to 17 years [8].

(This is a summary. Many women and men with hernia repairs are reporting system reactions to the mesh, which many experts say is not inert in the body)

2. The monofilament polypropylene mesh MUS is the most extensively studied anti-incontinence procedure in history

Midurethral sling (MUS) studies and more than 2,000 publications demonstrate the support the use of MUS as a treatment. A range of studies have consistently demonstrated clinical effectiveness and patient satisfaction. “No other surgical treatment for SUI before or since has been subject to such extensive investigation.”

(Summary of actual statement. SUI slings are not required to undergo clinical trials before they receive FDA approval.)

3. Polypropylene mesh midurethral slings are the standard of care for the surgical treatment of SUI and represent a great advance in the treatment of this condition for our patients.

“Since the publication of numerous level one randomized comparative trials, the MUS has become the most common surgical procedure for the treatment of SUI in the US and the developed world. Full-length midurethral slings, both retropubic and transobturator, have been extensively studied, are safe and effective relative to other treatment options and remain the leading treatment option and current gold standard for stress incontinence surgery [13]. Over 3 million MUS have been placed worldwide and a recent survey indicates that these procedures are used by > 99% of AUGS members [14].”

(Summary of the actual statement which does not mention the thousands of lawsuits filed by some of the women implanted with these slings).

4. The FDA has clearly stated that the polypropylene MUS is safe and effective in the treatment of SUI.

The midurethral sling was not the subject of the 2011 FDA Safety Communication, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for Pelvic Organ Prolapse.”[3]. In this document, it was explicitly stated: “The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report about that usage at a later date.” In 2013, the FDA website stated clearly that: “The safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year.” [5].

(Summary of statement which does not mention the FDA in January 2012 ordered sling makers to conduct 3 years of post-surgical patient monitoring. See story here.)

Conclusion from Position Statement

“The polypropylene midurethral sling has helped millions of women with SUI regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly. With its acknowledged safety and efficacy it has created an environment for a much larger number of women to have access to treatment. In the past, concerns over failure and invasiveness of surgery caused a substantial percent of incontinent women to live without treatment. One of the unintended consequences of this polypropylene mesh controversy has been to keep women from receiving any treatment for SUI. This procedure is probably the most important advancement in the treatment of stress urinary incontinence in the last 50 years and has the full support of our organizations which are dedicated to improving the lives of women with urinary incontinence.”

 

Learn More:

Mesh Medical Device News Desk, January 2012,  Mesh Makers who Received FDA Letters Requiring Postmarket Surveillance
https://www.meshmedicaldevicenewsdesk.com/fda-notices/mesh-makers-who-received-fda-letter-requiring-follow-up-tests/


FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, July 2011
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

 

AUGS & SUFU Position Statement
http://www.augs.org/p/bl/et/blogid=16&blogaid=192

Nilsson, C.G., et al., Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J, 2013. 24(8): p. 1265-9.  http://www.ncbi.nlm.nih.gov/pubmed/23563892

CG Nilsson, 11-year study on tape procedure for SUI, Intl Urogyn J. 2008,
http://www.newporturogynecology.com/pdf/nilsson.pdf

The ethical issues associated with the introduction of new surgical devices are discussed in a commentary by Ross et al. Ross S, Robert M, Harvey M, Farrell S, Schulz J, Wilkie D, et al. Ethicalissues associated with the introduction of new surgical devices, or just because we can, doesn’t mean we should. J Obstet Gynaecol Can2008;30:508–13    http://www.ncbi.nlm.nih.gov/pubmed/18611303

Society of Obstetricians and Gynecologists of Canada
http://sogc.org/wp-content/uploads/2013/01/gui254TU1102E.pdf