Sharrene Timothy v. Boston Scientific Corporation
Filing
OPINION ATTACHMENT. [15-1454]
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11/18/2016 Public Health Notifications (Medical Devices) > FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Sur...
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FDA Public Health Notification: Serious
Complications Associated with
Transvaginal Placement of Surgical Mesh
in Repair of Pelvic Organ Prolapse and
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Stress Urinary Incontinence 8/2
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For updated information about Surgical Mesh for Pelvic Organ Prolapse, see: UPDATE on Serious
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Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
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(/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm), released July 13, 2011.
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Issued: October 20, 2008
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15Dear Healthcare Practitioner:
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This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ
Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious
consequences. Following is information regarding the adverse events that have been reported to the FDA and
recommendations to reduce the risks.
Nature of the Problem
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of
complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are
usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and
recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation
during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of
life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the
mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm
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11/18/2016 Public Health Notifications (Medical Devices) > FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Sur...
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors
may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical
technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Recommendations
Physicians should:
Obtain specialized training for each mesh placement technique, and be aware of its risks.
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and
blood vessel perforations.
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the
implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during
sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.
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Additional patient information (/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm) can be found on
the following FDA Consumer website.
Reporting Adverse Events to FDA
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FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of
medical devices. If you suspect that a reportable adverse event was related to the use of surgical mesh, you should
follow the reporting procedure established by your facility.
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We also encourage you to report adverse events related to surgical mesh that do not meet the requirements for
mandatory reporting. You can report directly to MedWatch, the FDA Safety Information and Adverse Event
Reporting program online (/Safety/MedWatch/default.htm), by phone at 1800FDA1088, or obtain the fillable
form online (/Safety/MedWatch/HowToReport/DownloadForms/default.htm), print it out and fax to 1800FDA
0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 208529787.
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Getting More Information
FDA Medical Device Public Health Notifications
(/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/default.htm) are available on the Internet.
You can also be notified through email each time a new Public Health Notification is added to our web page. To
subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39
(http://service.govdelivery.com/service/subscribe.html?code=USFDA_39).
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11/18/2016 Public Health Notifications (Medical Devices) > FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Sur...
Sincerely,
Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration
If you have questions about this Notification, please contact FDA's Division of of Small Manufacturers, International
and Consumer Assistance (DSMICA) by email at dsmica@fda.hhs.gov (mailto:dsmica@fda.hhs.gov) or by
phone at 18006382041 or 3017967100
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More in Public Health Notifications (Medical Devices)
(/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/default.htm)
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