美国泌尿生殖学会反击经阴道补片禁令

美国泌尿生殖学会(AUGS)对盆底疾病治疗中禁止实施经阴道补片手术的企图予以了反击。在近期一份立场声明中，AUGS官员表达了对禁止合格的、有资质的外科医生实施经阴道补片手术的强烈反对。该声明是继一家州医疗组织、一个卫生保健系统和一家医疗事故公司认为或采纳了有关使用经阴道补片治疗盆腔器官脱垂或压力性尿失禁的禁令之后发出的。

Anthony Visco医生

AUGS主席兼杜克大学泌尿生殖科主任Anthony G. Visco医生认为，最佳的决策制定应该是医患间在无外界干扰的情况下进行的。AUGS目前在督促医院在评估施术医生能力方面多下功夫而不要一概禁止。Visco医生认为，与其下禁令禁止使用补片，倒不如医院和卫生系统采取严格的认证指导方针，让有资质的外科医生进行这些手术。

一些医院已经采纳了AUGS发布的指南，该指南概述了如何认证和审核进行经阴道置入外科手术用补片治疗盆腔器官脱垂和进行骶骨阴道固定治疗盆腔器官脱垂的外科医生。AUGS也推荐医院建立一支能对病例和并发症进行审核的盆底重建专家队伍，包括补片和非补片脱垂修补术。另外，AUGS还发布了一个知情同意文件包，推荐医院协助将审核患者的风险与收益的过程标准化。

应用经阴道补片治疗盆腔器官脱垂及压力性尿失禁在近年来一直存在争议，因为由该器材引起的不良事件报告渐增。在2011年7月，美国食品药品管理局(FDA)发布了一则安全性警告，其内容为“由用于盆腔器官脱垂经阴道修补术的外科补片引起的严重并发症并‘非罕见’，该手术可能会使患者的危险增加，其疗效未超越传统的非补片修补术”。FDA建议医生参加各项补片置入技术的专业培训，并且对潜在的不良事件提高警惕，其中包括补片腐蚀及感染。FDA在这则警告中还表示，仍在评估应用经阴道补片对压力性尿失禁治疗的影响。尽管FDA尚未采取行动将这些器材撤市，但已经责令泌尿生殖外科用补片的生产商进行上市后监测研究，以观察用于盆腔器官脱垂经阴道修补术的外科补片及用于治疗尿失禁的迷你吊带器材的安全性和有效性。

在2011年12月，AUGS和美国妇产科医师协会(ACOG)发布了声明，建议将盆腔器官脱垂经阴道补片修补术仅用于高危患者，比如反复发生脱垂或存在不宜采取内镜有创手术的医疗合并症的女性(Obstet. Gynecol. 2011;118:1459-64)。Visco医生表示，FDA发出的安全性警告并非支持禁用该手术，制定这样的禁令有可能会因为限制女性的医疗选择范围或限制研究者收集及分析安全性数据的能力而产生诸多负面后果。AUGS称，在某些情况下，使用经阴道补片治疗盆腔器官脱垂可能是患者的最佳手术选择，比如在采取非补片、自身组织修复术后脱垂复发的患者可能就是很好的候选人；另外，使用经阴道补片对于有严重腹内黏连的患者可能也是优选方案，因为腹部入路可能会产生更大的手术风险。

Visco医生担心禁止该手术的消息连同有关经阴道补片的诉讼案可能会导致部分女性不去治疗盆腔底部疾病。据AUGS称，对经阴道补片手术的禁令还可能会使有关这类产品的关键研究被叫停，比如盆底疾病网[由美国国家卫生研究院(NIH)资助的一家临床试验网]正准备启动的一项比较经阴道补片与非补片、自体组织修复术治疗子宫脱垂的随机试验。

AUGS正在与FDA、NIH及ACOG联合建立一家全国性盆底疾病注册处，将包括至少4大器械生产商，预计将于2013年下半年启动。一旦这家注册处建立并运作起来，外科医生将能够跟踪结局，并能彼此进行比较。

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By: MARY ELLEN SCHNEIDER, Ob.Gyn. News Digital Network

The American Urogynecologic Society is pushing back against attempts to ban transvaginal mesh surgery in the treatment of pelvic floor disorders.

In a recent position statement, officials at the American Urogynecologic Society (AUGS) voiced their strong opposition to restrictions on the use of transvaginal mesh surgery when performed by qualified, credentialed surgeons. The policy statement comes after a state medical organization, a health care system, and a medical malpractice company have considered or adopted bans on the use of transvaginal mesh for pelvic organ prolapse or stress urinary incontinence.

"We really feel that the best decision making is left between the patient and her physician without outside interference," Dr. Anthony G. Visco, AUGS president and division chief of urogynecology at Duke University, Durham, N.C. said in an interview.

Rather than an across-the-board ban, AUGS is urging hospitals to do a better job in assessing the competence of the surgeons performing these procedures.

"Instead of a ban on mesh, I think hospitals and health systems should adopt strict credentialing guidelines so that qualified surgeons are performing these procedures," Dr. Visco said.

Some hospitals have already adopted guidelines issued by AUGS that outline how to credential and audit surgeons who perform transvaginal placement of surgical mesh for pelvic organ prolapse and sacrocolpopexy for pelvic organ prolapse, he said. AUGS also recommends that hospitals form a group of pelvic floor reconstructive experts who can review cases and complications in both mesh and nonmesh prolapse repair. Additionally AUGS has released an informed consent toolkit that it recommends to hospitals to help standardize the process of reviewing risks and benefits with patients.

The use of transvaginal mesh to treat pelvic organ prolapse and stress urinary continence has been controversial in recent years as reports of adverse events from the devices have mounted. In July 2011, the Food and Drug Administration issued a safety notice warning that serious complications associated with surgical mesh for the transvaginal repair of pelvic organ prolapse are "not rare." The surgery may expose patients to greater risks without the benefit of being more effective than traditional nonmesh repairs, the FDA wrote.

The agency advised physicians to obtain specialized training for each mesh placement technique and to be vigilant about potential adverse events including mesh erosion and infection. In the same 2011 notice, the FDA said it was still evaluating the impact of transvaginal mesh in the treatment of stress urinary incontinence.

While the FDA has not acted to remove these devices from the market, it has ordered manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies to look at the safety and effectiveness of surgical mesh used for transvaginal repair of pelvic organ prolapse and mini-sling devices used to treat stress urinary incontinence.

In December 2011, AUGS and the American College of Obstetricians and Gynecologists issued their own statement recommending that pelvic organ prolapse vaginal mesh repair be reserved for high-risk cases such as women with recurrent prolapse or who have medical comorbidities that prevent more invasive endoscopic procedures (Obstet. Gynecol. 2011;118:1459-64).

The safety warnings from the FDA don’t warrant a ban on the procedure, Dr. Visco said. But enacting such a ban could have a number of negative consequences from limiting women’s medical options or limiting the ability of researchers to gather and analyze safety data, he said.

In certain cases, the use of transvaginal mesh for pelvic organ prolapse could be the patient’s best surgical option, according to AUGS. For example, patients with recurrent prolapse after a nonmesh, native tissue repair would be good candidates. Also, the use of transvaginal mesh might be preferred in patients with significant intra-abdominal adhesions because an abdominal approach would pose greater surgical risks.

Dr. Visco said he’s also concerned that news of bans on the procedure, combined with all the advertising about transvaginal mesh lawsuits, could lead some women to leave pelvic floor disorders untreated.

"I think patients are afraid," he said. "We’re worried that they’re so afraid that they may not even seek care."

Bans on transvaginal mesh surgeries could also put a stop to critical research on the products, according to AUGS. For instance, the Pelvic Floor Disorders Network, a clinical trials network funded by the National Institutes of Health, is preparing to launch a randomized trial of transvaginal mesh vs. nonmesh, native tissue repair for uterine prolapse.

And AUGS is building a national registry for pelvic floor disorders with the FDA, the NIH, and ACOG. The registry, which will include data from at least four major device manufacturers, is slated to launch later in 2013. Once the registry is up and running, surgeons will be able to track their outcomes and compare themselves to others.

"Our concern is that we don’t prematurely make a decision about these procedures before there’s a full assessment out there," Dr. Visco said.