Medicolegal Issues

The mesh mess, enmeshed in controversy

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

Beginning in the late 1990s, the US Food and Drug Administration cleared more than 150 devices using surgical mesh for urogynecologic indications. As of April 2019, there are no longer any FDA-approved surgical mesh products for transvaginal repair of pelvic organ prolapse. What happened?

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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.

CASE Complications with mesh placement for SUI

A 47-year-old woman (G4 P3013) presents 5 months posthysterectomy with evidence of urinary tract infection (UTI). Escherichia coli is isolated, and she responds to antibiotic therapy.

Her surgical history includes a mini-sling procedure using a needleless device and mesh placement in order to correct progressive worsening of loss of urine when coughing and sneezing. She also reported slight pelvic pain, dysuria, and urgency upon urination at that time. After subsequent development of pelvic organ prolapse (POP), she underwent the vaginal hysterectomy.

Following her UTI treatment, a host of problems occur for the patient, including pelvic pain and dyspareunia. Her male partner reports “feeling something during sex,” especially at the anterior vaginal wall. A plain radiograph of the abdomen identifies a 2 cm x 2 cm stone over the vaginal mesh. In consultation with female pelvic medicine and reconstructive surgery subspecialists, lithotripsy is performed, with the stone fragmented. The patient remains symptomatic, however.

The mesh is noted to be eroding through the vaginal wall. An attempt is made to excise the mesh, initially via transuretheral resection, then through a laparoscopic approach. Due to the mesh being embedded in the tissue, however, an open approach is undertaken. Extensive excision of the mesh and stone fragments is performed. Postoperatively, the patient reports “dry vagina,” with no other genitourinary complaints.

The patient sues. She sues the mesh manufacturer. She also seeks to sue the gynecologist who placed the sling and vaginal mesh (as she says she was not informed of “all the risks” of vaginal mesh placement. She is part of a class action lawsuit, along with thousands of other women.

WHAT’S THE VERDICT?

The device manufacturer settled out of court with the class action suit. (The gynecologist was never formally a defendant because the patient/plaintiff was advised to “drop the physician from the suit.”) The attorneys representing the class action received 40% of the award plus presented costs for the representation. The class as a whole received a little more than 50% of the negotiated award. The patient in this case received $60,000.

Medical background

Stress urinary incontinence (SUI) is a prevalent condition; it affects 35% of women.¹ Overall, 80% of women aged 80 or younger will undergo some form of surgery for POP during their lifetime.² The pathophysiology of SUI includes urethral hypermobility and intrinsic sphincter deficiency.³

Surgical correction for urinary incontinence: A timeline

Use of the gracilis muscle flap to surgically correct urinary incontinence was introduced in 1907. This technique has been replaced by today’s more common Burch procedure, which was first described in 1961. Surgical mesh use dates back to the 1950s, when it was primarily used for abdominal hernia repair. Tension-free tape was introduced in 1995.^4-6

Continue to: In the late 1990s the US Food and Drug Administration...

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

CASE Complications with mesh placement for SUI

WHAT’S THE VERDICT?

Medical background

Surgical correction for urinary incontinence: A timeline

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