outcomes stratified by surgeon. This is especially true when evaluating novel procedural outcomes that require unique techniques and surgical skill sets that must be developed along with the innovation. Financial Disclosure: Dr. Lucente has been a speaker for Allergan. He has been a speaker, performed research, and been a consultant for AMS, Bard, and Coloplast. Dr. Roberts did not report any potential conflicts of interest.
Carlos A. Roberts, MD Wellspan Health, York, Pennsylvania Vincent R. Lucente, MD, MBA St Luke’s University, Health Network, Allentown, Pennsylvania
REFERENCES 1. Gutman RE, Nosti PA, Sokol AI, Sokol ER, Peterson JL, Wang H, et al. Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 2013;122:770–7. 2. Withagen MI, Vierhout ME, Hendriks JC, Kluivers KB, Milani AL. Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure. Obstet Gynecol 2011;118:629–36. 3. Ward K, Hilton P, United K; Ireland Tension-free Vaginal Tape Trial G. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002; 325:67. 4. Vintzileos AM. Evidence-based compared with reality-based medicine in obstetrics. Obstet Gynecol 2009;113: 1335–40.
In Reply: I appreciate the opportunity to respond on behalf of my co-authors to the comments and concerns raised by Drs. Roberts and Lucente. We performed initial outcomes stratification by surgeon at the time of the primary paper and found no difference in the rates of mesh exposure.1 Although we agree that surgeon factors may affect patient outcomes, the 15.6% mesh exposure rate and premature halting caused us to be underpowered to detect a difference, a limitation that has been recognized in each publication. Furthermore, we would like to point out that all of the surgeons in this trial were fellowship-trained, high-volume sur-
VOL. 123, NO. 3, MARCH 2014
geons who were “certified” and trained to perform Prolift (pelvic floor repair system) by one of two surgeons who were the highest-volume implanters. Finally, the inherent problems with the pelvic floor repair system have been recognized in multiple trials showing high mesh exposure rates (17–21%)2,3 and complications,4 ultimately leading to withdrawal of this device from the marketplace. Fortunately, research efforts are underway with the help of industry, the U.S. Food and Drug Administration, and the American Urogynecologic Society to perform postmarket surveillance studies using the newly developed Pelvic Floor Disorders Registry. We believe that new surgical innovation and second-generation vaginal mesh repairs should be safe and effective in the hands of the majority of high-volume surgeons and not just an isolated few. Financial Disclosure: The author did not report any potential conflicts of interest.
Robert E. Gutman, MD, FPMRS National Center for Advanced Pelvic Surgery, MedStar Washington Hospital Center, Ob/Gyn & Urology, Georgetown University School of Medicine, Washington, DC
Safety of Influenza A (H1N1) 2009 Live Attenuated Monovalent Vaccine in Pregnant Women To the Editor: The recent report on H1N1 2009 live attenuated monovalent vaccine in pregnant women is very interesting.1 In obstetrics, the problem of H1N1 2009 influenza infection is important.2 Prevention of this infection is required.2 Vaccination is a widely used preventive method. Moro et al conclude that “rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates.”1 In general, influenza vaccine is a safe vaccine for the pregnant woman. The present report by Moro et al1 repeatedly confirms the previous report from the same authors, Moro et al.3 However, only obstetric outcome is focused on in the present report.1 If all outcomes are considered, a difference in rate of adverse effects might be observed. According to the recent report by the Centers for Disease Control and Prevention, the rate of adverse outcome of H1N1 2009 vaccination is equal to 82/1 million vaccine doses distributed, which is about two times higher than that of the seasonal influenza vaccination (47/1 million doses distributed4).
REFERENCES 1. Gutman RE, Nosti PA, Sokol AI, Sokol ER, Peterson JL, Wang H, et al. Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 2013;122:770–7. 2. Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocarguided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol 2011;117:242–50. 3. Halaska M, Maxova K, Sottner O, Svabik K, Mlcoch M, Kolarik D, et al. A multicenter, randomized, prospective, controlled study comparing sacrospinous fixation and transvaginal mesh in the treatment of posthysterectomy vaginal vault prolapse. Am J Obstet Gynecol 2012;207:301. 4. Caquant F, Collinet P, Debodinance P, Berrocal J, Garbin O, Rosenthal C, et al. Safety of Trans Vaginal Mesh procedure: Retrospective study of 684 patients. J Obstet Gynaecol Res 2008;34: 449–56.
Financial Disclosure: The author did not report any potential conflicts of interest.
Viroj Wiwanitkit Faculty of Medicine University of Nis Nis, Serbia
REFERENCES 1. Moro PL, Museru OI, Broder K, Cragan J, Zheteyeva Y, Tepper N, et al. Safety of influenza a (H1N1) 2009 live attenuated monovalent vaccine in pregnant women. Obstet Gynecol 2013;122: 1271–8. 2. Wiwanitkit V. Obstetrical concern on new emerging swine flu. Arch Gynecol Obstet 2010;281:369. 3. Moro PL, Broder K, Zheteyeva Y, Revzina N, Tepper N, Kissin D, et al. Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event
Letters to the Editor
665
Reporting System. Am J Obstet Gynecol 2011;205:473.e1–9.
nant women. Obstet Gynecol 2013;122: 1271–8.
4. Centers for Disease Control and Prevention (CDC). Safety of influenza A (H1N1) 2009 monovalent vaccines - United States, October 1-November 24, 2009. MMWR Morb Mortal Wkly Rep 2009; 58:1351–6.
2. Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009 [published erratum appears in MMWR Recomm Rep 2009;58:896–7]. MMWR Recomm Rep 2009;58:1–52.
In Reply: We thank Dr. Wiwanitkit for his comments regarding our study.1 It is important to keep in mind that live attenuated influenza vaccines were not recommended in pregnant women.2,3 Ours was a special study that used reports of pregnant women who in most cases appeared to have inadvertently received the live H1N1 influenza vaccine and in whom reports were submitted because this vaccine was not recommended in pregnancy. We were able to prospectively follow the pregnancy outcomes of these women and their infants and were able to calculate incidence rates for certain pregnancy outcomes, which is not possible using only routinely submitted reports to surveillance systems such as the Vaccine Adverse Event Reporting System. In our approach, we were able to avoid some important limitations of passive surveillance systems such as the Vaccine Adverse Event Reporting System, including overreporting or underreporting. The study that Dr. Wiwanitkit references4 is not comparable with our study. It was an assessment of Vaccine Adverse Event Reporting System reports that did not include prospective follow-up and was subject to underreporting, and the rate of adverse events was calculated based on estimated doses of the vaccine administered. Financial Disclosure: The author did not report any potential conflicts of interest.
Pedro L. Moro, MD, MPH Immunization Safety Office, Division Of Healthcare Quality Promotion, NCEZID, Centers for Disease Control and Prevention, Atlanta, Georgia
REFERENCE 1. Moro PL, Museru OI, Broder K, Cragan J, Zheteyeva Y, Tepper N, et al. Safety of Influenza a (H1N1) 2009 live attenuated monovalent vaccine in preg-
666
Letters to the Editor
3. National Center for Immunization and Respiratory Diseases, CDC; Centers for Disease Control and Prevention (CDC). Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep 2009;58:1–8. 4. Centers for Disease Control and Prevention (CDC). Safety of influenza A (H1N1) 52 2009 monovalent vaccines - United States, October 1-November 24, 2009. MMWR Morb Mortal Wkly Rep 2009; 58:1351–6.
Scope of Global Health Training in U.S. Obstetrics and Gynecology Residency Programs To the Editor: As clearly stated in the article by Hung et al,1 maternal health in low-resource areas is a substantive public health concern. The patient burden overwhelms the number of adequately trained health care providers, which makes timely access to optimal health care almost nonexistent. Global health has become a priority to many individual physicians and residency programs alike. The descriptions provided by Hung et al of various programs were informative, but the list was not comprehensive. If our modestly sized community hospital provides opportunity beyond the scope discussed in this article, how many other programs were excluded that offer their residents global health opportunities? Western Connecticut Health Network and the University of Vermont have established an innovative global health program, which includes weekly tropical medicine lectures, journal clubs focusing on global ethical issues, monthly global health seminars, and community outreach programs. Residents and medical students are funded to do an elective rotation at one of our four international
sites as a complement to the certificate program. Host faculty from our partner institution are invited to participate in an observership program, which is funded by our Global Health department, to give them perspective on the American health care system. Women’s global health is the focus of many medical students interested in obstetrics and gynecology, and the existence of established programs likely will affect their selection in the U.S. National Resident Matching Program. It is imperative that a women’s global health organization be developed that recognizes and brings together all programs committed to such work. This would allow medical students to appropriately choose a program whose objectives coincide with their personal interest as well as allow obstetrics and gynecology residency programs to collaborate and provide more efficient care to the women of the world. Financial Disclosure: The authors did not report any potential conflicts of interest.
Karina Haber, MD Robert Samuelson, MD Shohreh Shahabi, MD Danbury Hospital, Danbury Connecticut
REFERENCE 1. Hung KJ, Tsai AC, Johnson T, Walensky RP, Bangsberg DR, Kerry VB. Scope of global health training in U.S. obstetrics and gynecology residency programs. J Obstet Gynecol 2013;122:1101–9.
In Reply: We thank Haber et al for bringing their global health program to our attention. Their program may benefit from being publicized on the department’s web site. As described in our article,1 we agree with Haber et al that interest in global health among medical students appears to be on the upswing. Providing prospective residency applicants with access to official, up-to-date information2 about their program may help to attract students with specific interests in global health. It is possible that their program would have been included in our analysis if we had employed a study design such as a survey of program directors or of graduating residents. As we described, these alternatives likely would have been limited by unpredictable biases resulting from low response
OBSTETRICS & GYNECOLOGY
Carlos A. Roberts, MD Wellspan Health, York, Pennsylvania Vincent R. Lucente, MD, MBA St Luke’s University, Health Network, Allentown, Pennsylvania
REFERENCES 1. Gutman RE, Nosti PA, Sokol AI, Sokol ER, Peterson JL, Wang H, et al. Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 2013;122:770–7. 2. Withagen MI, Vierhout ME, Hendriks JC, Kluivers KB, Milani AL. Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure. Obstet Gynecol 2011;118:629–36. 3. Ward K, Hilton P, United K; Ireland Tension-free Vaginal Tape Trial G. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002; 325:67. 4. Vintzileos AM. Evidence-based compared with reality-based medicine in obstetrics. Obstet Gynecol 2009;113: 1335–40.
In Reply: I appreciate the opportunity to respond on behalf of my co-authors to the comments and concerns raised by Drs. Roberts and Lucente. We performed initial outcomes stratification by surgeon at the time of the primary paper and found no difference in the rates of mesh exposure.1 Although we agree that surgeon factors may affect patient outcomes, the 15.6% mesh exposure rate and premature halting caused us to be underpowered to detect a difference, a limitation that has been recognized in each publication. Furthermore, we would like to point out that all of the surgeons in this trial were fellowship-trained, high-volume sur-
VOL. 123, NO. 3, MARCH 2014
geons who were “certified” and trained to perform Prolift (pelvic floor repair system) by one of two surgeons who were the highest-volume implanters. Finally, the inherent problems with the pelvic floor repair system have been recognized in multiple trials showing high mesh exposure rates (17–21%)2,3 and complications,4 ultimately leading to withdrawal of this device from the marketplace. Fortunately, research efforts are underway with the help of industry, the U.S. Food and Drug Administration, and the American Urogynecologic Society to perform postmarket surveillance studies using the newly developed Pelvic Floor Disorders Registry. We believe that new surgical innovation and second-generation vaginal mesh repairs should be safe and effective in the hands of the majority of high-volume surgeons and not just an isolated few. Financial Disclosure: The author did not report any potential conflicts of interest.
Robert E. Gutman, MD, FPMRS National Center for Advanced Pelvic Surgery, MedStar Washington Hospital Center, Ob/Gyn & Urology, Georgetown University School of Medicine, Washington, DC
Safety of Influenza A (H1N1) 2009 Live Attenuated Monovalent Vaccine in Pregnant Women To the Editor: The recent report on H1N1 2009 live attenuated monovalent vaccine in pregnant women is very interesting.1 In obstetrics, the problem of H1N1 2009 influenza infection is important.2 Prevention of this infection is required.2 Vaccination is a widely used preventive method. Moro et al conclude that “rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates.”1 In general, influenza vaccine is a safe vaccine for the pregnant woman. The present report by Moro et al1 repeatedly confirms the previous report from the same authors, Moro et al.3 However, only obstetric outcome is focused on in the present report.1 If all outcomes are considered, a difference in rate of adverse effects might be observed. According to the recent report by the Centers for Disease Control and Prevention, the rate of adverse outcome of H1N1 2009 vaccination is equal to 82/1 million vaccine doses distributed, which is about two times higher than that of the seasonal influenza vaccination (47/1 million doses distributed4).
REFERENCES 1. Gutman RE, Nosti PA, Sokol AI, Sokol ER, Peterson JL, Wang H, et al. Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 2013;122:770–7. 2. Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocarguided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol 2011;117:242–50. 3. Halaska M, Maxova K, Sottner O, Svabik K, Mlcoch M, Kolarik D, et al. A multicenter, randomized, prospective, controlled study comparing sacrospinous fixation and transvaginal mesh in the treatment of posthysterectomy vaginal vault prolapse. Am J Obstet Gynecol 2012;207:301. 4. Caquant F, Collinet P, Debodinance P, Berrocal J, Garbin O, Rosenthal C, et al. Safety of Trans Vaginal Mesh procedure: Retrospective study of 684 patients. J Obstet Gynaecol Res 2008;34: 449–56.
Financial Disclosure: The author did not report any potential conflicts of interest.
Viroj Wiwanitkit Faculty of Medicine University of Nis Nis, Serbia
REFERENCES 1. Moro PL, Museru OI, Broder K, Cragan J, Zheteyeva Y, Tepper N, et al. Safety of influenza a (H1N1) 2009 live attenuated monovalent vaccine in pregnant women. Obstet Gynecol 2013;122: 1271–8. 2. Wiwanitkit V. Obstetrical concern on new emerging swine flu. Arch Gynecol Obstet 2010;281:369. 3. Moro PL, Broder K, Zheteyeva Y, Revzina N, Tepper N, Kissin D, et al. Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event
Letters to the Editor
665
Reporting System. Am J Obstet Gynecol 2011;205:473.e1–9.
nant women. Obstet Gynecol 2013;122: 1271–8.
4. Centers for Disease Control and Prevention (CDC). Safety of influenza A (H1N1) 2009 monovalent vaccines - United States, October 1-November 24, 2009. MMWR Morb Mortal Wkly Rep 2009; 58:1351–6.
2. Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009 [published erratum appears in MMWR Recomm Rep 2009;58:896–7]. MMWR Recomm Rep 2009;58:1–52.
In Reply: We thank Dr. Wiwanitkit for his comments regarding our study.1 It is important to keep in mind that live attenuated influenza vaccines were not recommended in pregnant women.2,3 Ours was a special study that used reports of pregnant women who in most cases appeared to have inadvertently received the live H1N1 influenza vaccine and in whom reports were submitted because this vaccine was not recommended in pregnancy. We were able to prospectively follow the pregnancy outcomes of these women and their infants and were able to calculate incidence rates for certain pregnancy outcomes, which is not possible using only routinely submitted reports to surveillance systems such as the Vaccine Adverse Event Reporting System. In our approach, we were able to avoid some important limitations of passive surveillance systems such as the Vaccine Adverse Event Reporting System, including overreporting or underreporting. The study that Dr. Wiwanitkit references4 is not comparable with our study. It was an assessment of Vaccine Adverse Event Reporting System reports that did not include prospective follow-up and was subject to underreporting, and the rate of adverse events was calculated based on estimated doses of the vaccine administered. Financial Disclosure: The author did not report any potential conflicts of interest.
Pedro L. Moro, MD, MPH Immunization Safety Office, Division Of Healthcare Quality Promotion, NCEZID, Centers for Disease Control and Prevention, Atlanta, Georgia
REFERENCE 1. Moro PL, Museru OI, Broder K, Cragan J, Zheteyeva Y, Tepper N, et al. Safety of Influenza a (H1N1) 2009 live attenuated monovalent vaccine in preg-
666
Letters to the Editor
3. National Center for Immunization and Respiratory Diseases, CDC; Centers for Disease Control and Prevention (CDC). Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep 2009;58:1–8. 4. Centers for Disease Control and Prevention (CDC). Safety of influenza A (H1N1) 52 2009 monovalent vaccines - United States, October 1-November 24, 2009. MMWR Morb Mortal Wkly Rep 2009; 58:1351–6.
Scope of Global Health Training in U.S. Obstetrics and Gynecology Residency Programs To the Editor: As clearly stated in the article by Hung et al,1 maternal health in low-resource areas is a substantive public health concern. The patient burden overwhelms the number of adequately trained health care providers, which makes timely access to optimal health care almost nonexistent. Global health has become a priority to many individual physicians and residency programs alike. The descriptions provided by Hung et al of various programs were informative, but the list was not comprehensive. If our modestly sized community hospital provides opportunity beyond the scope discussed in this article, how many other programs were excluded that offer their residents global health opportunities? Western Connecticut Health Network and the University of Vermont have established an innovative global health program, which includes weekly tropical medicine lectures, journal clubs focusing on global ethical issues, monthly global health seminars, and community outreach programs. Residents and medical students are funded to do an elective rotation at one of our four international
sites as a complement to the certificate program. Host faculty from our partner institution are invited to participate in an observership program, which is funded by our Global Health department, to give them perspective on the American health care system. Women’s global health is the focus of many medical students interested in obstetrics and gynecology, and the existence of established programs likely will affect their selection in the U.S. National Resident Matching Program. It is imperative that a women’s global health organization be developed that recognizes and brings together all programs committed to such work. This would allow medical students to appropriately choose a program whose objectives coincide with their personal interest as well as allow obstetrics and gynecology residency programs to collaborate and provide more efficient care to the women of the world. Financial Disclosure: The authors did not report any potential conflicts of interest.
Karina Haber, MD Robert Samuelson, MD Shohreh Shahabi, MD Danbury Hospital, Danbury Connecticut
REFERENCE 1. Hung KJ, Tsai AC, Johnson T, Walensky RP, Bangsberg DR, Kerry VB. Scope of global health training in U.S. obstetrics and gynecology residency programs. J Obstet Gynecol 2013;122:1101–9.
In Reply: We thank Haber et al for bringing their global health program to our attention. Their program may benefit from being publicized on the department’s web site. As described in our article,1 we agree with Haber et al that interest in global health among medical students appears to be on the upswing. Providing prospective residency applicants with access to official, up-to-date information2 about their program may help to attract students with specific interests in global health. It is possible that their program would have been included in our analysis if we had employed a study design such as a survey of program directors or of graduating residents. As we described, these alternatives likely would have been limited by unpredictable biases resulting from low response
OBSTETRICS & GYNECOLOGY
