作用的手術醫師（vaginal mesh complication surgens）
FDA Mesh Warning: Transvaginal Mesh Complications
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.
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。
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 Meshelated Adverse Events May Have Serious Consequences, FDA Warns
By Yael Waknine
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 email@example.com. 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.