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.

There are a number of limits on manufacturer liability for defective devices. For Class III devices, the thorough FDA review of the safety of a device may limit the ability of an injured patient to sue based on the state product liability laws.¹⁴ For the most part, this “preemption” of state law has not played a major role in mesh litigation because they were initially classified as Class II devices which did not require or include a detailed FDA review.¹⁵

The duty to warn of the dangers and risk of medical devices means that manufacturers (or sellers) of devices are obligated to inform health care providers and other medical personnel of the risks. Unlike other manufacturers, device manufacturers do not have to directly warn consumers—because physicians deal directly with patients and prescribe the devices. Therefore, the health care providers, rather than the manufacturers, are obligated to inform the patient.¹⁶ This is known as the learned intermediary rule. Manufacturers may still be liable for failure to warn if they do not convey to health care providers proper warnings.

Manufacturers and sellers are not the only entities that may be subject to liability caused by medical devices. Hospitals or other entities that stock and care for devices are responsible for maintaining the safety and functionality of devices in their care.

Health care providers also may be responsible for injuries from medical devices. Generally, that liability is based on negligence. Negligence may relate to selecting an improper device, installing or using it incorrectly, or failing to give the patient adequate information (or informed consent) about the device and alternatives to it.¹⁷

A look at the mesh mess

There are a lot of distressing problems and professional disappointments in dissecting the “mesh mess,” including a failure of the FDA to regulate effectively, the extended sale and promotion of intrinsic sphincter deficiency mesh products, the improper use of mesh by physicians even after the risks were known, and, in some instances, the taking advantage of injured patients by attorneys and businesses.¹⁸ A lot of finger pointing also has occurred.¹⁹ We will recount some of the lowlights of this unfortunate tale.

Continue to: The FDA, in the 1990s, classified the first POP and SUI mesh...

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

A look at the mesh mess

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