A 14-Year Multi-Institutional Collaborative Study of Chinese Pelvic Floor Surgical Procedures Related to Pelvic Organ Prolapse
Pelvic organ prolapse (POP) is a common condition affecting women, with a lifetime risk of 11% to 19% for undergoing surgery. Over the past two decades, the use of synthetic mesh in pelvic floor surgeries has become increasingly prevalent, particularly in the treatment of POP. However, this rise in mesh use has been accompanied by a significant increase in reported complications, leading to heightened scrutiny and regulatory actions worldwide. This study aims to provide a comprehensive overview of the development of Chinese pelvic floor surgeries related to POP over a 14-year period, from October 1, 2004, to September 30, 2018, and to investigate the potential influence of enhanced monitoring by the Chinese Association of Urogynecology since 2011.
The study included data from 44,594 women with POP who underwent pelvic floor surgeries at 22 tertiary academic medical centers across China. The data were voluntarily reported and obtained from a centralized database. The study compared the proportion of different surgical procedures in the 7 years before and after September 30, 2011, to assess the impact of enhanced monitoring. The data were analyzed using a one-sided Z test, with statistical significance defined as a P value less than 0.05.
The results revealed that the number of pelvic floor surgeries related to POP performed between October 1, 2011, and September 30, 2018, was more than twice that of the period from October 1, 2004, to September 30, 2011. Specifically, the rate of synthetic mesh procedures increased from 38.1% (5,298/13,906) to 46.0% (14,107/30,688), while the rate of non-mesh procedures decreased from 61.9% (8,608/13,906) to 54.0% (16,581/30,688). This shift in surgical practice was statistically significant (Z = 15.53, P < 0.001).
Within the category of synthetic mesh surgeries, the rate of transvaginal placement of surgical mesh (TVM) procedures decreased from 94.1% (4,983/5,298) to 82.2% (11,603/14,107), while the rate of laparoscopic sacrocolpopexy (LSC) procedures increased from 5.9% (315/5,298) to 17.8% (2,504/14,107). These changes were also statistically significant (Z = 20.79, P < 0.001 for TVM; Z = 20.79, P < 0.001 for LSC).
The increase in the rate of synthetic mesh procedures in China can be attributed to several factors. First, there has been an enhanced recognition of pelvic floor disorders, leading to an increase in both the number of patient visits and the demand for surgical interventions. Second, the establishment of the Chinese Urogynecology Association in 2005 has promoted the recruitment and training of professional pelvic surgery doctors, thereby increasing the availability of specialized care. Third, international collaborations and the introduction of advanced surgical techniques from abroad have further facilitated the adoption of synthetic mesh surgeries. Fourth, professional training programs on mesh-related surgeries have increased the number of physicians skilled in performing these procedures, particularly LSC. Finally, some studies have supported the efficacy of synthetic mesh procedures over native tissue repairs, with better outcomes reported in certain cases.
Despite the global trend of increasing complications associated with TVM, the rate of synthetic mesh procedures in China has continued to rise. The 2011 public health notification (PHN) by the United States Food and Drug Administration (FDA) highlighted the risks of complications related to TVM, leading to a decrease in its use in many countries. In China, the Chinese Association of Urogynecology responded by enhancing the monitoring of synthetic mesh surgeries, focusing on appropriate patient selection, adequate preoperative assessments, structured surgeon training, and good surgical techniques to minimize the risk of postoperative complications.
The increase in the rate of LSC procedures can be attributed to its perceived advantages over TVM. LSC is associated with a lower rate of complications, better preservation of sexual function, and shorter hospital stays due to its minimally invasive nature. Studies have shown that LSC has a similar success rate to TVM but with fewer adverse events. For example, a study comparing LSC and TVM found that the complication rates of intraoperative bleeding, bladder injury, and postoperative perineal pain were lower in the LSC group, and objective satisfaction was higher.
The findings of this study are consistent with global trends, where the use of synthetic mesh in POP surgeries has been a subject of debate. While some studies have demonstrated the efficacy and safety of synthetic mesh procedures, others have highlighted the risks of complications, leading to regulatory actions and changes in clinical practice. In the United States, the FDA issued warnings in 2008 and 2011 regarding the risks of TVM, leading to a decrease in its use. Similarly, in countries like Australia, New Zealand, and the United Kingdom, the use of vaginal mesh has been restricted or suspended due to safety concerns.
In China, the debate on the use of synthetic mesh in POP surgeries continues. While the rate of TVM procedures has decreased, the rate of LSC procedures has increased, reflecting a shift in surgical practice. The Chinese Association of Urogynecology has emphasized the importance of informed consent, robust governance measures, and ongoing monitoring to ensure patient safety. Surgeons are encouraged to obtain specialized training in mesh placement techniques and to carefully select patients for synthetic mesh surgeries.
This study has several limitations. First, the data were obtained retrospectively from 22 hospitals in China, which may not fully represent the national landscape of pelvic floor surgeries. Second, the preferences and skills of individual surgeons may have influenced the type and number of procedures performed. Third, the study lacked detailed information on patient characteristics, previous treatments, surgery indications, and long-term outcomes, which could provide a more comprehensive understanding of the factors influencing surgical practice. Fourth, the study did not analyze conservative treatments, such as the use of pessaries and pelvic floor muscle training, which are important components of POP management.
Despite these limitations, this study provides valuable insights into the development of Chinese pelvic floor surgeries related to POP over a 14-year period. The findings highlight the increasing use of synthetic mesh procedures, particularly LSC, and the impact of enhanced monitoring by the Chinese Association of Urogynecology. The study underscores the importance of ongoing research, training, and governance to ensure the safety and efficacy of pelvic floor surgeries in China.
In conclusion, the number of pelvic floor surgeries related to POP in China has increased significantly over the past 14 years, with a notable shift towards synthetic mesh procedures, particularly LSC. The rate of TVM procedures has decreased, reflecting concerns about complications, while the rate of LSC procedures has increased due to its perceived advantages. The Chinese Association of Urogynecology has played a crucial role in enhancing the monitoring of synthetic mesh surgeries, emphasizing the importance of informed consent, specialized training, and ongoing surveillance. Future research should focus on long-term outcomes, patient preferences, and the integration of conservative treatments to provide a more comprehensive approach to the management of POP in China.
doi.org/10.1097/CM9.0000000000001237
Was this helpful?
0 / 0