Medicolegal Issues

The mesh mess, enmeshed in controversy

OBG Manag. 2019 July;31(7):35-41

References

Maral I, Ozkardeş H, Peşkircioğlu L, et al. Prevalence of stress urinary incontinence in both sexes at or after age 15 years: a cross-sectional study. J Urol. 2001;165:408-412.
Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501-506.
Chang J, Lee D. Midurethral slings in the mesh litigation era. Transl Androl Urol. 2017;6(suppl 2): S68-S75.
Mattingly R, ed. TeLinde's Operative Gynecology, 5th edition. Lippincott, William, and Wilkins: Philadelphia, PA; 1997.
Burch J. Urethrovaginal fixation to Cooper's ligament for correction of stress incontinence, cystocele, and prolapse. Am J Obstet Gynecol. 1961;81:281-290.
Ulmsten U, Falconer C, Johnson P, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:210-213.
Kuhlmann-Capek MJ, Kilic GS, Shah AB, et al. Enmeshed in controversy: use of vaginal mesh in the current medicolegal environment. Female Pelvic Med Reconstr Surg. 2015;21:241-243.
Powell SF. Changing our minds: reforming the FDA medical device reclassification process. Food Drug Law J. 2018;73:177-209.
US Food and Drug Administration. Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence. September 2011. https://www.thesenatorsfirm.com/documents/OBS.pdf. Accessed June 19, 2019.
Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;(4):CD004014.
Ganj FA, Ibeanu OA, Bedestani A, Nolan TE, Chesson RR. Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:919-925.
Sung VW, Rogers RG, Schaffer JI, et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol. 2008;112:1131-1142.
FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. October 20, 2008. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Accessed February 14, 2019.
Riegel v. Medtronic, 552 U.S. 312 (2008).
Whitney DW. Guide to preemption of state-law claims against Class III PMA medical devices. Food Drug Law J. 2010;65:113-139.
Alam P, Iglesia CB. Informed consent for reconstructive pelvic surgery. Obstet Gynecol Clin North Am. 2016;43:131-139.
Nosti PA, Iglesia CB. Medicolegal issues surrounding devices and mesh for surgical treatment of prolapse and incontinence. Clin Obstet Gynecol. 2013;56:221-228.
Shepherd CG. Transvaginal mesh litigation: a new opportunity to resolve mass medical device failure claims. Tennessee Law Rev. 2012;80:3:477-94.
Karlovsky ME. How to avoid and deal with pelvic mesh litigation. Curr Urol Rep. 2016;17:55.
Cohn JA, Timbrook Brown E, Kowalik CG, et al. The mesh controversy. F1000Research website. https://f1000research.com/articles/5-2423/v1. Accessed June 17, 2019.
Obstetrics and Gynecology Devices Panel Meeting, February 12, 2019. US Food and Drug Administration website. https://www.fda.gov/media/122867/download. Accessed June 19, 2019.
Mucowski SJ, Jurnalov C, Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol. 2010;203:103.e1-e4.
American College of Obstetricians and Gynecologists Committee on Ethics. ACOG Committee Opinion No. 439: informed consent. Obstet Gynecol. 2009;114(2 pt 1):401-408.
Souders CP, Eilber KS, McClelland L, et al. The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg. 2018;24:21-25.
Goldstein M. As pelvic mesh settlements near $8 billion, women question lawyers' fees. New York Times. February 1, 2019. https://www.nytimes.com/2019/02/01/business/pelvic-mesh-settlements-lawyers.html. Accessed June 19, 2019.
Johnson G. Surgeons fear pelvic mesh lawsuits will spook patients. Associated Press News. January 10, 2019. https://www.apnews.com/25777c3c33e3489283b1dc2ebdde6b55. Accessed June 19, 2019.
Clarke RN. Medical device marketing and the ethics of vaginal mesh kit marketing. In The Innovation and Evolution of Medical Devices. New York, NY: Springer; 2019:103-123.
Top 5 drug and medical device developments of 2018. Law 360. January 1, 2019. Accessed through LexisNexis.
Frankel A, Dye J. The Lien Machine. New breed of investor profits by financing surgeries for desperate women patients. Reuters. August 18, 2015. https://www.reuters.com/investigates/special-report/usa-litigation-mesh/. Accessed June 19, 2019.
Sullivan T. New report looks at intersection of "medical lending" and pelvic mesh lawsuits. Policy & Medicine. May 5, 2018. https://www.policymed.com/2015/08/medical-lending-and-pelvic-mesh-litigation.html. Accessed June 19, 2019.
Goldstein M, Sliver-Greensberg J. How profiteers lure women into often-unneeded surgery. New York Times. April 14, 2018. https://www.nytimes.com/2018/04/14/business/vaginal-mesh-surgery-lawsuits-financing.html. Accessed June 19, 2019.

The FDA, in the 1990s, classified the first POP and SUI mesh as Class II after deciding these products were “substantially equivalent” to older surgical meshes. This, of course, proved not to be the case.²⁰ The FDA started receiving thousands of reports of adverse events and, in 2008, warned physicians to be vigilant for adverse events from the mesh. The FDA’s notification recommendations regarding mesh included the following¹³:

Obtain specialized training for each mesh implantation technique, and be cognizant of risks.

Be vigilant for potential adverse events from mesh, including erosion and infection.
Be observant for complications associated with tools of transvaginal placement (ie, bowel, bladder, and vessel perforation).
Inform patients that implantation of mesh is permanent and complications may require additional surgery for correction.
Be aware that complications may affect quality of life—eg, pain with intercourse, scarring, and vaginal wall narrowing (POP repair).
Provide patients with written copy of patient labeling from the surgical mesh manufacturer.

In 2011, the FDA issued a formal warning to providers that transvaginal mesh posed meaningful risks beyond nonmesh surgery. The FDA’s bulletin draws attention to how the mesh is placed more so than the material per se.^19,21 Mesh was a Class II device for sacrocolpopexy or midurethral sling and, similarly, the transvaginal kit was also a Class II device. Overall, use of mesh midurethral slings has been well received as treatment for SUI. The FDA also accepted it for POP, however, but with increasingly strong warnings. The FDA’s 2011 communication stated, “This update is to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare….Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”^7,13

In 2014 the FDA proposed reclassifying mesh to a Class III device, which would require that manufacturers obtain approval, based on safety and effectiveness, before selling mesh. Not until 2016 did the FDA actually reclassify the mess as Class III. Of course, during this time, mesh manufacturers were well aware of the substantial problems the products were causing.¹³

After serious problems with mesh became well known, and especially after FDA warnings, the use of mesh other than as indicated by the FDA was increasingly risky from a legal (as well as a health) standpoint. As long as mesh was still on the market, of course, it was available for use. But use of mesh for POP procedures without good indications in a way that was contrary to the FDA warnings might well be negligent.

Changes to informed consent

The FDA warnings also should have changed the informed consent for the use of mesh.²² Informed consent commonly consists of the following:

informing the patient of the proposed procedure
describing risks (and benefits) of the proposed process
explaining reasonable alternatives
noting the risks of taking no action.

Information that is material to a decision should be disclosed. If mesh were going to be used, after the problems of mesh were known and identified by the FDA (other than midurethral slings as treatment of SUI), the risks should have been clearly identified for patients, with alternatives outlined. The American College of Obstetricians and Gynecologists Committee on Ethics has 8 fundamental concepts with regard to informed consent that are worth keeping in mind²³:

Obtaining informed consent for medical treatment and research is an ethical requirement.
The process expresses respect for the patient as a person.
It protects patients against unwanted treatment and allows patients’ active involvement in medical planning and care.
Communication is of paramount importance.
Informed consent is a process and not a signature on a form.
A commitment to informed consent and to provision of medical benefit to the patient are linked to provision of care.
If obtaining informed consent is impossible, a designated surrogate should be identified representing the patient’s best interests.
Knowledge on the part of the provider regarding state and federal requirements is necessary.

Continue to: Lawsuits line up...

References

Maral I, Ozkardeş H, Peşkircioğlu L, et al. Prevalence of stress urinary incontinence in both sexes at or after age 15 years: a cross-sectional study. J Urol. 2001;165:408-412.
Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501-506.
Chang J, Lee D. Midurethral slings in the mesh litigation era. Transl Androl Urol. 2017;6(suppl 2): S68-S75.
Mattingly R, ed. TeLinde's Operative Gynecology, 5th edition. Lippincott, William, and Wilkins: Philadelphia, PA; 1997.
Burch J. Urethrovaginal fixation to Cooper's ligament for correction of stress incontinence, cystocele, and prolapse. Am J Obstet Gynecol. 1961;81:281-290.
Ulmsten U, Falconer C, Johnson P, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:210-213.
Kuhlmann-Capek MJ, Kilic GS, Shah AB, et al. Enmeshed in controversy: use of vaginal mesh in the current medicolegal environment. Female Pelvic Med Reconstr Surg. 2015;21:241-243.
Powell SF. Changing our minds: reforming the FDA medical device reclassification process. Food Drug Law J. 2018;73:177-209.
US Food and Drug Administration. Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence. September 2011. https://www.thesenatorsfirm.com/documents/OBS.pdf. Accessed June 19, 2019.
Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;(4):CD004014.
Ganj FA, Ibeanu OA, Bedestani A, Nolan TE, Chesson RR. Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:919-925.
Sung VW, Rogers RG, Schaffer JI, et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol. 2008;112:1131-1142.
FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. October 20, 2008. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Accessed February 14, 2019.
Riegel v. Medtronic, 552 U.S. 312 (2008).
Whitney DW. Guide to preemption of state-law claims against Class III PMA medical devices. Food Drug Law J. 2010;65:113-139.
Alam P, Iglesia CB. Informed consent for reconstructive pelvic surgery. Obstet Gynecol Clin North Am. 2016;43:131-139.
Nosti PA, Iglesia CB. Medicolegal issues surrounding devices and mesh for surgical treatment of prolapse and incontinence. Clin Obstet Gynecol. 2013;56:221-228.
Shepherd CG. Transvaginal mesh litigation: a new opportunity to resolve mass medical device failure claims. Tennessee Law Rev. 2012;80:3:477-94.
Karlovsky ME. How to avoid and deal with pelvic mesh litigation. Curr Urol Rep. 2016;17:55.
Cohn JA, Timbrook Brown E, Kowalik CG, et al. The mesh controversy. F1000Research website. https://f1000research.com/articles/5-2423/v1. Accessed June 17, 2019.
Obstetrics and Gynecology Devices Panel Meeting, February 12, 2019. US Food and Drug Administration website. https://www.fda.gov/media/122867/download. Accessed June 19, 2019.
Mucowski SJ, Jurnalov C, Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol. 2010;203:103.e1-e4.
American College of Obstetricians and Gynecologists Committee on Ethics. ACOG Committee Opinion No. 439: informed consent. Obstet Gynecol. 2009;114(2 pt 1):401-408.
Souders CP, Eilber KS, McClelland L, et al. The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg. 2018;24:21-25.
Goldstein M. As pelvic mesh settlements near $8 billion, women question lawyers' fees. New York Times. February 1, 2019. https://www.nytimes.com/2019/02/01/business/pelvic-mesh-settlements-lawyers.html. Accessed June 19, 2019.
Johnson G. Surgeons fear pelvic mesh lawsuits will spook patients. Associated Press News. January 10, 2019. https://www.apnews.com/25777c3c33e3489283b1dc2ebdde6b55. Accessed June 19, 2019.
Clarke RN. Medical device marketing and the ethics of vaginal mesh kit marketing. In The Innovation and Evolution of Medical Devices. New York, NY: Springer; 2019:103-123.
Top 5 drug and medical device developments of 2018. Law 360. January 1, 2019. Accessed through LexisNexis.
Frankel A, Dye J. The Lien Machine. New breed of investor profits by financing surgeries for desperate women patients. Reuters. August 18, 2015. https://www.reuters.com/investigates/special-report/usa-litigation-mesh/. Accessed June 19, 2019.
Sullivan T. New report looks at intersection of "medical lending" and pelvic mesh lawsuits. Policy & Medicine. May 5, 2018. https://www.policymed.com/2015/08/medical-lending-and-pelvic-mesh-litigation.html. Accessed June 19, 2019.
Goldstein M, Sliver-Greensberg J. How profiteers lure women into often-unneeded surgery. New York Times. April 14, 2018. https://www.nytimes.com/2018/04/14/business/vaginal-mesh-surgery-lawsuits-financing.html. Accessed June 19, 2019.

FDA warning letters fall on Trump’s watch

The mesh mess, enmeshed in controversy

References

Changes to informed consent

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