繼2008年美國FDA 發出警訊後,在2011年又再發出另

一次警訊,而現今美國已出現專門處理陰道放置網體的相關副

作用的手術醫師(vaginal mesh complication surgens)

 

圖片1  

 

FDA網警告:經陰道網並發症並不少見

(google翻譯的,有空我再修改一下)

日期:2011年8月10日:陰道網律師
 
 

食品和藥物管理局(FDA)於2011年7月13日,發布了經陰道手術

網狀佈局的嚴重並發症的安全通信更新。這些程序已被用來治療盆

腔器官脫垂(POP),一個令人痛心的和痛苦的條件下,在盆腔內

器官,如子宮,膀胱,腸,向下滑動著鼓鼓的,或脫垂,成陰道。

機關可以在某些情況下,過去的陰道口突出。POP是減弱的陰道壁,

有時由於分娩的結果。它可以導致應力性尿失禁(SUI)由於對膀胱

的壓力,以及一般的疼痛和不適,性交干擾,精神痛苦。經陰道手術

的網格已被用於支持通過一個切口放置陰道壁減弱。然而,這個最新

的FDA更新發出通知醫療服務提供者和病人“與持久性有機污染物的

陰道修復手術網相關的嚴重並發症並不少見。”據報導,這些陰道網

格副作用包括:慢性疼痛,性交時疼痛,無力從事性交,感染,出血

,陰道疤痕,復發的脫垂,縮短或收緊陰道,臟器穿孔,尿痛。許多

這些網格通過陰道壁的侵蝕,一些網收縮所造成的。

FDA建議,其他治療方案由醫生認為這些手術之前。許多經陰道網傷害

的受害者據說需要多個修訂手術,試圖糾正他們所面臨的問題,有時

沒有成功。在此警告燈,它是重要的,這些程序已受傷的婦女學習他

們的合法權益。經陰道網訴訟,目前正在對眾多廠商提出。如果你已

經受傷,經陰道網程序或安置聯繫我們今天的免費諮詢,並找出如果

你能為你的陰道網狀問題尋求補償。 

FDA Mesh Warning: Transvaginal Mesh Complications 

Not Rare

Date: August 10, 2011By: Vaginal Mesh Attorneys
 
 
 

On July 13, 2011, the Food and Drug Administration (FDA) released a safety communication update on the serious complications of transvaginal surgical mesh placement. These procedures have been used to treat pelvic organ prolapse (POP), a distressing and painful condition in which the inner pelvic organs, such as the uterus, bladder, and bowel, slide downward and forward to the point of bulging, or prolapsing, into the vagina. In some cases, the organ may protrude past the vaginal opening. POP is the result of weakened vaginal walls, sometimes due to childbirth. It can causes stress urinary incontinence (SUI) due to pressure on the bladder, as well as general pain and discomfort, interference with sexual intercourse, and mental distress.

Transvaginal surgical meshes have been used to support weakened vaginal walls by placement through an incision. However, this most recent FDA update was issued to inform healthcare providers and patients “that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” These transvaginal mesh side effects reportedly include: chronic pain, pain during sex, an inability to engage in sexual intercourse, infection, bleeding, vaginal scarring, recurrence of prolapse, shortening or tightening of the vagina, perforation of organs, and painful urination. Many of these are caused by erosion of the mesh through the vaginal wall, and some by a contraction of the mesh.

The FDA recommends that other treatment options be considered by physicians before proceeding with these surgeries. Many transvaginal mesh injury victims have reportedly required multiple revision surgeries to attempt to correct the issues they have faced, sometimes without success. In light of this warning, it is important that women who have been injured by these procedures learn their legal rights. Transvaginal mesh lawsuits are currently being filed against numerous manufacturers. If you have been injured by a transvaginal mesh procedure or placement, contact us today for a free consultation and to find out if you can seek compensation for your vaginal mesh problems. 



 

 

FDA警告:經陰道放置網體的相關副作用可能有嚴重後果


作者:Yael Waknine

出處:WebMD醫學新知

  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/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(例如移除網體)、靜脈點滴治療、輸血、或者血腫/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FDAMedWatch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 Meshelated 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.

 

 

創作者介紹

Dr.Yen 鄢源貴醫師醫療服務站(非痞客邦會員勿用悄悄話留言,我會無法回覆)

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