Long-term Device Outcomes of Mesh Implants in Pelvic Organ Prolapse Repairs
OBJECTIVE:To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs. METHODS:We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State...
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| Veröffentlicht in: | Obstetrics and gynecology (New York. 1953) 2020-03, Vol.135 (3), p.591-598 |
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| container_title | Obstetrics and gynecology (New York. 1953) |
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| creator | Chughtai, Bilal Mao, Jialin Asfaw, Tirsit S. Heneghan, Carl Rardin, Charles R. Sedrakyan, Art |
| description | OBJECTIVE:To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs.
METHODS:We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis.
RESULTS:We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4–6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27–1.54, P |
| doi_str_mv | 10.1097/AOG.0000000000003689 |
| format | Article |
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METHODS:We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis.
RESULTS:We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4–6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27–1.54, P<.001). The estimated risk of undergoing a reintervention at 5 years was 8.8% (95% CI 8.2–9.3%) in the mesh group and 6.3% (5.9–6.8%) in the nonmesh group. Among patients who had reinterventions, 18.5% of those operated with mesh had a reintervention related to mesh-related complications.
CONCLUSION:Even though transvaginal mesh has been removed from the market, the risk of mesh complications did not diminish over time and these women warrant close follow-up. Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.</description><identifier>ISSN: 0029-7844</identifier><identifier>EISSN: 1873-233X</identifier><identifier>DOI: 10.1097/AOG.0000000000003689</identifier><identifier>PMID: 32028486</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins</publisher><subject>Aged ; Female ; Gynecologic Surgical Procedures - adverse effects ; Gynecologic Surgical Procedures - instrumentation ; Gynecologic Surgical Procedures - statistics & numerical data ; Humans ; Longitudinal Studies ; Middle Aged ; New York - epidemiology ; Pelvic Organ Prolapse - surgery ; Postoperative Complications - epidemiology ; Postoperative Complications - etiology ; Surgical Mesh - adverse effects ; Surgical Mesh - statistics & numerical data</subject><ispartof>Obstetrics and gynecology (New York. 1953), 2020-03, Vol.135 (3), p.591-598</ispartof><rights>Lippincott Williams & Wilkins</rights><rights>2020 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4479-380181e556db2ddfa98ced04abab39629f781cb1c3cf6dd499cbd1a4596e88473</citedby><cites>FETCH-LOGICAL-c4479-380181e556db2ddfa98ced04abab39629f781cb1c3cf6dd499cbd1a4596e88473</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32028486$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chughtai, Bilal</creatorcontrib><creatorcontrib>Mao, Jialin</creatorcontrib><creatorcontrib>Asfaw, Tirsit S.</creatorcontrib><creatorcontrib>Heneghan, Carl</creatorcontrib><creatorcontrib>Rardin, Charles R.</creatorcontrib><creatorcontrib>Sedrakyan, Art</creatorcontrib><title>Long-term Device Outcomes of Mesh Implants in Pelvic Organ Prolapse Repairs</title><title>Obstetrics and gynecology (New York. 1953)</title><addtitle>Obstet Gynecol</addtitle><description>OBJECTIVE:To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs.
METHODS:We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis.
RESULTS:We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4–6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27–1.54, P<.001). The estimated risk of undergoing a reintervention at 5 years was 8.8% (95% CI 8.2–9.3%) in the mesh group and 6.3% (5.9–6.8%) in the nonmesh group. Among patients who had reinterventions, 18.5% of those operated with mesh had a reintervention related to mesh-related complications.
CONCLUSION:Even though transvaginal mesh has been removed from the market, the risk of mesh complications did not diminish over time and these women warrant close follow-up. Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.</description><subject>Aged</subject><subject>Female</subject><subject>Gynecologic Surgical Procedures - adverse effects</subject><subject>Gynecologic Surgical Procedures - instrumentation</subject><subject>Gynecologic Surgical Procedures - statistics & numerical data</subject><subject>Humans</subject><subject>Longitudinal Studies</subject><subject>Middle Aged</subject><subject>New York - epidemiology</subject><subject>Pelvic Organ Prolapse - surgery</subject><subject>Postoperative Complications - epidemiology</subject><subject>Postoperative Complications - etiology</subject><subject>Surgical Mesh - adverse effects</subject><subject>Surgical Mesh - statistics & numerical data</subject><issn>0029-7844</issn><issn>1873-233X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkV1LwzAUhoMoOj_-gUguvenMV9PkcsxPnExEwbuSpqdbtV1r0jr892Zsinih5-Zw4HnPCU8QOqZkSIlOzkbTqyH5UVwqvYUGVCU8Ypw_b6MBIUxHiRJiD-17_xIgKjXfRXucEaaEkgN0O2kWs6gDV-NzeC8t4Gnf2aYGj5sC34Gf45u6rcyi87hc4HuoAoSnbmbC4JrKtB7wA7SmdP4Q7RSm8nC06Qfo6fLicXwdTaZXN-PRJLJCJDriilBFIY5lnrE8L4xWFnIiTGYyriXTRaKozajltpB5LrS2WU6NiLUEpUTCD9Dpem_rmrcefJfWpbdQhVdC0_uU8ZhJrlWiAyrWqHWN9w6KtHVlbdxHSkm60pgGjelvjSF2srnQZzXk36EvbwFQa2DZVEGef636Jbh0Dqbq5v_tFn9EV5hkMYnCpRAIU7T6NsE_AXd8jYI</recordid><startdate>20200301</startdate><enddate>20200301</enddate><creator>Chughtai, Bilal</creator><creator>Mao, Jialin</creator><creator>Asfaw, Tirsit S.</creator><creator>Heneghan, Carl</creator><creator>Rardin, Charles R.</creator><creator>Sedrakyan, Art</creator><general>Lippincott Williams & Wilkins</general><general>by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20200301</creationdate><title>Long-term Device Outcomes of Mesh Implants in Pelvic Organ Prolapse Repairs</title><author>Chughtai, Bilal ; Mao, Jialin ; Asfaw, Tirsit S. ; Heneghan, Carl ; Rardin, Charles R. ; Sedrakyan, Art</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4479-380181e556db2ddfa98ced04abab39629f781cb1c3cf6dd499cbd1a4596e88473</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Female</topic><topic>Gynecologic Surgical Procedures - adverse effects</topic><topic>Gynecologic Surgical Procedures - instrumentation</topic><topic>Gynecologic Surgical Procedures - statistics & numerical data</topic><topic>Humans</topic><topic>Longitudinal Studies</topic><topic>Middle Aged</topic><topic>New York - epidemiology</topic><topic>Pelvic Organ Prolapse - surgery</topic><topic>Postoperative Complications - epidemiology</topic><topic>Postoperative Complications - etiology</topic><topic>Surgical Mesh - adverse effects</topic><topic>Surgical Mesh - statistics & numerical data</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chughtai, Bilal</creatorcontrib><creatorcontrib>Mao, Jialin</creatorcontrib><creatorcontrib>Asfaw, Tirsit S.</creatorcontrib><creatorcontrib>Heneghan, Carl</creatorcontrib><creatorcontrib>Rardin, Charles R.</creatorcontrib><creatorcontrib>Sedrakyan, Art</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chughtai, Bilal</au><au>Mao, Jialin</au><au>Asfaw, Tirsit S.</au><au>Heneghan, Carl</au><au>Rardin, Charles R.</au><au>Sedrakyan, Art</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term Device Outcomes of Mesh Implants in Pelvic Organ Prolapse Repairs</atitle><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle><addtitle>Obstet Gynecol</addtitle><date>2020-03-01</date><risdate>2020</risdate><volume>135</volume><issue>3</issue><spage>591</spage><epage>598</epage><pages>591-598</pages><issn>0029-7844</issn><eissn>1873-233X</eissn><abstract>OBJECTIVE:To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs.
METHODS:We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis.
RESULTS:We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4–6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27–1.54, P<.001). The estimated risk of undergoing a reintervention at 5 years was 8.8% (95% CI 8.2–9.3%) in the mesh group and 6.3% (5.9–6.8%) in the nonmesh group. Among patients who had reinterventions, 18.5% of those operated with mesh had a reintervention related to mesh-related complications.
CONCLUSION:Even though transvaginal mesh has been removed from the market, the risk of mesh complications did not diminish over time and these women warrant close follow-up. Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins</pub><pmid>32028486</pmid><doi>10.1097/AOG.0000000000003689</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Obstetrics and gynecology (New York. 1953), 2020-03, Vol.135 (3), p.591-598 |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Aged Female Gynecologic Surgical Procedures - adverse effects Gynecologic Surgical Procedures - instrumentation Gynecologic Surgical Procedures - statistics & numerical data Humans Longitudinal Studies Middle Aged New York - epidemiology Pelvic Organ Prolapse - surgery Postoperative Complications - epidemiology Postoperative Complications - etiology Surgical Mesh - adverse effects Surgical Mesh - statistics & numerical data |
| title | Long-term Device Outcomes of Mesh Implants in Pelvic Organ Prolapse Repairs |
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