FDA警告:經陰道放置網體的相關副作用可能有嚴重後果


  October 21, 2008 — 美國食品藥物管理局(FDA)日前發表警訊表示,醫師應該接受經陰道放置網體的特殊訓練,並對副作用有所警惕。
  
  骨盆器官脫垂與壓力性尿失禁手術用的網體相關併發症,雖然罕見但可能會有嚴重後果;在過去三年,九家外科網體製造商提出了超過1,000例併發症報告,包括侵蝕陰道上皮、感染、疼痛、泌尿問題、脫垂和/或失禁復發。
  
  雖然網體放置手術被視為侵犯性極低,但是曾有報告指出腸道、膀胱和血管穿孔;在一些案例中,陰道結疤處和網體侵蝕導致嚴重不舒服和疼痛,會嚴重降低病患的生活品質。
  
  再者,這些併發症的治療可能還會引起疼痛,甚至需要後續手術(例如移除網體)、靜脈點滴治療、輸血、或者血腫/膿瘍引流。
  
  FDA指出,雖然還不清楚特定因素,但併發症的風險可能受到病患整體健康、網體材質、大小、形狀、使用的外科技術、與當時的術式,如子宮切除術等影響,而雌激素狀態也可能是個風險因素。
  
  FDA建議健康照護專業人士接受每種網體放置技術的專業訓練,也須對網體相關副作用(例如侵蝕和感染)和放置相關的併發症(如穿孔)有所警惕;此外,需告知病患網體放置是永久的,並告知有相關併發症的可能性。如果可以的話,提供一份書面的病患須知。
  
  可以寫信到1350 Piccard Drive, Rockville, Maryland, 20850、或傳真240-276-3356、或寫電子郵件phann@cdrh.fda.gov給監督與生物測定辦公室(Office of Surveillance and Biometrics[HFZ-510])獲得此警訊的詳細資訊,在240-276-3357留言也可獲得迅速回覆。
  
  http://www.fda.gov/cdrh/consumer/surgicalmesh-popsui.html 和http://www.fda.gov/cdrh/consumer/surgicalmesh-hernias.html 均有提供病患資訊。
  
  此外,網體相關副作用應向FDA的MedWatch通報計畫報告,可以打電話1-800-FDA-1088、傳真1-800-FDA-0178、上網http://www.fda.gov/medwatch或寫信到5600 Fishers Lane, Rockville, MD 20852-9787。

Transvaginal MeshRelated Adverse Events May Have Serious Consequences, FDA Warns

By Yael Waknine
Medscape Medical News

October 21, 2008 — Clinicians should receive specialized training for the transvaginal placement of mesh products and be vigilant for adverse events, the US Food and Drug Administration (FDA) warned yesterday in a news release.

Though rare, complications associated with surgical mesh treatment of pelvic organ prolapse and stress urinary incontinence can have serious consequences. During the last 3 years, 9 surgical mesh manufacturers have submitted more than 1000 reports of complications that have included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.

Although mesh placement procedures are considered to be minimally invasive, bowel, bladder, and blood vessel perforations have also been reported. In some cases, vaginal scarring and mesh erosion have led to significant discomfort and pain, significantly decreasing the patient's quality of life.

Moreover, treatment of these complications can be painful and require further surgery (some for mesh removal), intravenous therapy, blood transfusion, or hematoma/abscess drainage.

The FDA notes that although specific characteristics remain unclear, the risk for complications may be affected by overall patient health, mesh material, mesh size/shape, surgical technique used, and concomitant procedures such as hysterectomy. Estrogen status may also be a contributing risk factor.

Healthcare professionals are advised to obtain specialized training for each mesh placement technique and to be aware and vigilant for mesh-related adverse events (eg, erosion and infection) as well as placement-related complications (eg, perforation).

Patients should be informed that mesh placement is permanent and advised of the potential for and nature of related complications. If possible, a written copy of the patient labeling for the device should be made available.

Additional information regarding this alert may be obtained from the Office of Surveillance and Biometrics (HFZ-510) by mail at 1350 Piccard Drive, Rockville, Maryland, 20850; by fax at 240-276-3356; or by e-mail at phann@cdrh.fda.gov. Voicemail messages left at 240-276-3357 will be returned as soon as possible.

Patient information is also available online at http://www.fda.gov/cdrh/consumer/surgicalmesh-popsui.html and http://www.fda.gov/cdrh/consumer/surgicalmesh-hernias.html.

Mesh-related adverse events should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

    
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