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2014년06월03일 17시44분
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탈장 수술에 사용하는 ‘인공 막 부작용’ 심각
미FDA ‘강력 경고‘ 올해까지 세 차례‥‘위험 수위 3단계’ 격상

부작용 ‘극심한 통증부터 장기와 신경손상, 대장 천공까지’ 다양
미국서만 ‘수천 건 피해 소송’ 진행 중
선진국 탈장 전문센터, ‘무인공막 수술’로 대처‥국내 의료기관은 무감각 “나 몰라라”
강윤식 원장 “잇단 부작용 환자 재수술‥무인공막 1000례 결과 부작용 재발률 1%”

재작년 중순 서해부탈장 수술을 받은 김00(39세)씨. 그는 작년부터 수술 주변의 통증으로 항생제 치료를 받아왔다.

하지만 통증은 사그라지기는커녕 최근엔 혈뇨까지 나타나 정밀검사를 받았다.
결과는 탈장 수술에 사용한 인공 막의 부작용으로 방광에 염증이 생겼다는 진단이 나왔다.
결국 그는 인공막 제거술을 받아야만 했다.

김 씨는 “극심한 통증 때문에 여러 병원을 찾아 다녔지만 원인을 찾는데만 꼬박 1년이 넘게 걸렸다”면서 “시간이 더 지체됐다면 끔찍한 상황을 맞이할 수 있었다는 진단의사의 말에 소름이 돋았다. 당시 안전하다며 수술한 병원이 원망스럽기까지 하다”는 말까지 꺼냈다.

김 씨처럼 어려움을 당하지 않으려면 탈장 수술 방법선택에 주의를 기울여야 할 것으로 보인다.

미국 FDA가 탈장 수술 시 몸 안에 삽입되는 인공막의 부작용에 올 들어 또 다시 강력하게 경고하고 나섰다. 이젠 3번째로 위험성의 수위단계를 더욱 끌어 올렸다.

미FDA, 올해 또 경고‥위험 수위 2->3단계 격상
심각한 인공막 부작용에 소송만 1천 건 이상

사진) 탈장수술에 쓰이는 인공막(상), 부작용을 겪은 환자 체내에서 제거된 인공막(하)

미국 FDA가 탈장 인공 막에 첫 경고를 한 것은 지난 2008년이다.
이후 2년 뒤 2010년에 두 번째 경고를 하면서 이 과정에서 인공 막을 의료시장에서 수거했다.

하지만 의료현장에서 여전히 인공막 삽입으로 생기는 부작용이 큰 문제로 떠오르면서 미국 FDA는 지난 4월 위험수위를 기존 2단계(중간 위험 재료)에서 3단계로(위험 높은 재료)로 높여 다시 경고했다.

이런 FDA의 조치는 미국에서만 탈장 인공막 삽입에 따른 부작용으로 수천 건 넘는 소송이 제기되는 심각해진 현실을 반영한 것이다.

미국 FDA는 화학물질 인공 막의 심각한 합병증을 현지 의약계에 줄곧 알려왔다.
현지 환자들은 의사들에게 인공막이 사용될 경우 발생할 수 있는 상황을 충분하게 설명해달라고 요구하면서 “(추후 발생할 수 있는 피해)를 대비해 가능하면 의사의 설명을 복사본으로 건네줄 것”을 요구했다.

인공 막으로부터 생기는 부작용으로 가장 흔한 증상은 일상생활을 할 수 없을 정도의 극심한 만성통증이다.
이 증상은 인공막이 이물질이어서 주변 조직을 압박하거나 당기면서 발생하는 후유증이라는 거다.

또 주변 조직과 유착되거나 주변 장기, 신경, 혈관 등에 손상을 입히기도 한다는 것이다.
심한 경우 화학섬유 인공막이 장기의 부드러운 조직에 계속 압박, 손상을 입히면서 대장 혹은 방광을 뚫어버리는 천공까지 생긴다는 것이다.

세계 전문탈장센터들, 자체 수술법으로 ‘무인공막 탈장술’ 시행
국내 의료기관에선 “거의 없다”

이처럼 인공 막의 부작용이 전해지면서 세계적으로 유명한 탈장센터가 있는 미국이나 유럽 등세계적으로 유명한 탈장센터에선 아예 새 방식의 탈장 수술을 하고 있는 실정이다.
센터들이 인공 막을 아예 뺀 채 경험을 거듭하면서 환자들을 위해 개발한 수술법들을 활용하고 있는 거다.

이 같은 추세와 달리 우리나라의 현실은 판이하게 다르다는 게 기쁨병원 강윤식 원장의 지적이다.

그에 따르면 우리나라 거의 모든 의료기관들이 절제술이나 복강경을 할 때 인공막 수술만 고집하다는 것이다.

사진) 기쁨병원 강윤식 원장의 무인공막 탈장 수술 모습 

강 원장은 “국내 의료기관들은 FDA가 강력하게 경고조치를 할 정도로 부작용이 심각한 인공 막에 관심조차 두지 않아 결국 환자들만 피해를 본다”며 “인공막 탈장 수술 후 부작용으로 이곳저곳의 병원을 전전하다 찾아오는 환자들이 적지 않다. 원인이 되는 이물질 인공막을 제거하면서 무인공막 방법으로 재수술을 시행하고 있다”고 강조했다.

무인공막 탈장 수술은 말 그대로 인공막을 사용하지 않는 탈장 수술법이다.
기쁨병원은 자체 개발한 새로운 무인공막 수술법으로 지금까지 1000례 이상 시행했다고 한다.
이 결과 부작용은 거의 나타나지 않았으며 재발률도 인공막 수술(3-4%)보다 낮은 1% 미만이었다는 게 강 원장의 설명이다.

강 원장은 “의사 입장에서 보면 무인공막 수술이 까다로운 것은 사실이지만 부작용을 생각한다면 인공 막을 사용을 하지 말아야 한다”면서 “이미 탈장 수술을 받은 환자라면 6개월 이상 통증이 지속될 경우 부작용을 의심해야 한다. 생활에 불편을 느끼면 바로 전문의를 찾아 진단과 적절한 치료를 받는 것이 바람직하다”고 말했다.

미FDA, 올해 또 경고(아래 내용)
위험 수위 2->3단계 격상

Surgical Mesh
For updated information about Surgical Mesh for Pelvic Organ Prolapse,
see: Urogynecologic Surgical Mesh Implants, released July 13, 2011.

• Information on Surgical Mesh for Hernia Repairs
• Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence

Information on Surgical Mesh for Hernia Repairs

FDA wants to inform you about complications that may occur with the surgical mesh that is sometimes used to repair hernias, and to provide you with questions you may want to ask your surgeon before having this procedure. This is part of our commitment to keep the public informed about the medical products we regulate.

Hundreds of thousands of hernia repair operations are performed each year both with and without surgical mesh, and patients generally recover quickly and do well after surgery.

However, FDA has received reports of complications associated with the mesh. The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.

Most of the complications reported to us so far have been associated with mesh products that have been recalled and are no longer on the market. For further information on the recalled products, please visit the FDA Medical Device Recall website.

We are continuing to analyze and evaluate incoming reports of adverse events, and are speaking with patients, surgeons and researchers. We will inform the public as new information becomes available.

Talking to your doctor

Before having a hernia operation, be sure to let the surgeon know if you’ve had a past reaction to materials used in surgical mesh or sutures, such as polypropylene.

There are also certain questions you should consider asking your surgeon:
• What are the pros and cons of using surgical mesh in my particular case?
• If surgical mesh will be used, is there special patient information that comes with the product, and can I have a copy?
• If surgical mesh will be used, what’s been your experience with this particular product, and with treating potential mesh complications?
• What can I expect to feel after surgery and for how long?
Reporting complications to the FDA

In order to help FDA learn more about possible problems with surgical mesh, it’s important that both physicians and patients report complications that may be associated with this product.

You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online : MedWatch Online Voluntary Reporting Form (3500)
• Regular Mail : use postage-paid FDA form 3500 available at: MedWatch Forms Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178

Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.

FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.

The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.

In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain,

including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels .

Background

A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum.

Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity.

Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.

Talking to your doctor

Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene.

Questions you should ask the surgeon before you agree to surgery in which mesh will be

used:

• What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
• If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
• What’s been your experience in dealing with the complications that might occur?
• What can I expect to feel after surgery and for how long?
• Are there any specific side effects I should let you know about after the surgery?
• What if the mesh doesn’t correct my problem?
• If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
• If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Reporting complications to the FDA

In order to help FDA learn more about possible problems with surgical mesh, it is important that both physicians and patients report complications that may be associated with this product.

You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.

• Online : MedWatch Online Voluntary Reporting Form (3500)
• Mail : use postage-paid FDA form 3500 available at: MedWatch Forms Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178

Related Links
• FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks

Agency says other options may expose women to less risk than transvaginal procedure The U.S. Food and Drug Administration today issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.

Pelvic Organ Prolapse (POP) occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.”

William Maisel (MD, MPH, FDA’s Center for Devices and Radiological Health In 2010, there were at least 100,000 POP repairs that used surgical mesh. About 75,000 of these were transvaginal procedures.

The FDA issued a safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has continued to climb. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.  The reports don’t always differentiate between transvaginal and abdominal procedures.

The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection,

bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems.  Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.

The FDA also conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries.

FDA recommends that health care providers:

• Recognize that in most cases, POP can be treated successfully without mesh;
• Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
• Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and
• Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.

The FDA recommends that patients:

• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and

• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

The FDA also announced that an outside panel of experts in obstetrics and gynecology will meet on Sept. 8-9, 2011, to discuss the safety and effectiveness of surgical mesh used to treat POP and stress urinary incontinence (SUI), a leakage of urine during physical activity. The panel will discuss the risk of transvaginal POP repair, clinical studies that may be necessary to address risks and benefits of this type of surgery, and the FDA’s interim recommendations for health care professionals and patients.

“Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for POP and SUI repair, including any changes that would improve our oversight,” Maisel said.

Today’s safety communication is limited to the transvaginal placement of mesh to repair POP. It does not address the safety and effectiveness of mesh used to treat SUI or mesh implanted abdominally.

For more information:

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

미국FDA 탈장 인공막 경고 외신 보도

FDA NEWS RELEASE
For Immediate Release: April 29, 2014

Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA, DICE@fda.hhs.gov FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort,
disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those
risks for more safe and effective products,” said William Maisel, M.D., M.P.H.,

deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”

William Maisel (MD, MPH, FDA’s Center for Devices and Radiological Health Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Many mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body. Instruments provided in kits will be reviewed as part of the regulatory submission for the mesh product. Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).

Beginning in Jan. 2012, the FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.

In Sept. 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require PMAs.

In July 2011, the FDA provided an updated safety communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP. At that time, the FDA also released a review of urogynecologic surgical meshadverse events and peer-reviewed scientific literature that identified serious safety and effectiveness concerns. The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI) in an Oct. 2008 FDA Public Health
Notification.

Surgical mesh indicated for surgical treatments of SUI, abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications are not part of this proposed order.
The FDA will take comments on the proposed order for 90 days.

For more information:

• FDA Medical Devices

• FDA: Proposed Order - “Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation”

• FDA: Proposed Order - “Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair”

• FDA: Urogynecologic Surgical Mesh Implants

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The FDA just announced that mesh, used during surgery to treat pelvic organ prolapse, has an extremely high rate of erosion (up to 10 percent) and probably shouldn't be used.

Now for the finger pointing: Either cowboy gynecologic surgeons were too quick to adopt mesh in the O.R. or the FDA's 510(k) approval process was too quick to allow mesh in gynecologic surgery.

I think these are not the important lessons. I think the FDA's approval process has little to do with it and I think the real losers are going to be (again) women with prolapse.

But first some background: pelvic organ prolapse occurs when the support structures for women's pelvic organs -- their bladder, urethra, vagina, uterus, even rectum -- weaken or stretch, allowing those organs to shift in a way that causes discomfort or affects function.

If the supporting tissue between the bladder and the vagina weakens, for example, the bladder can push into the vagina, causing an inability to urinate, incontinence and discomfort. Intercourse can become problematic. In general, pelvic organ prolapse is no fun.

The surgeries to repair prolapse -- which all involve strengthening supporting structures and sometimes involve suspending organs that have "fallen" -- has a long and troubled past. The history of gynecology is littered with surgical procedures for prolapse that didn't work. In the past 15 years, however, a lot of old surgeries have been abandoned when well-designed clinical trials demonstrated that they didn't work, and a series of new procedures have come into vogue -- many incorporating mesh.

The problem now is that the mesh in some procedures (but not all) has a tendency to erode -- wearing through the vaginal mucosa and exposing its rough and uncomfortable surface to the patient and her sexual partner -- or constrict and scar, causing tightening and discomfort.

Some of these procedures have been stunning successes. Procedures that place mesh under the urethra (the tube that carries urine from the bladder to the outside) are generally quick, require minimal recovery, are safe and are proven to cure a particular type of incontinence. (This use of mesh is not part of the FDA warning, although this distinction may be lost on patients.)

But other mesh procedures, in which mesh is used to support one or more of the vaginal walls, have led to complications. The mesh used for these surgeries is essentially the same mesh used (successfully) by general surgeons to repair hernias and other abdominal wall defects. Here is why FDA reform, for the most part, isn't going to help.

Medicine cross pollinates from one field to another -- we call it innovation. There is a long tradition of taking drugs and devices approved for one purpose and using them for another purpose. Once a device is FDA approved, physicians can (at their peril) use them for pretty much whatever they like. So it is with mesh. I believe that making it harder to get mesh approved for hernia repairs isn't going to make it less likely to erode into women's vaginas -- it's just going to slow down the process of getting discoveries into the clinics and into the O.R.

And the cowboy gynecologic surgeons? These are the innovators who brought about the successful mesh sling procedures that now cure 95 percent of women of incontinence in 30 minutes (when surgeries with 50 percent success rates used to take 5 hours in the O.R. and require weeks of recovery). Millions of women have benefited from the extraordinary era of innovation in gynecologic surgery over the past 15 years. Do we really want these surgeons to stop innovating?

The irony is that as gynecologic surgeons became aware of the mesh problem, they turned back to surgeries that don't use mesh – but also aren't as effective. Vaginal wall repairs without mesh fail 35-40 percent of the time (and the repeat procedures are even less successful), so surgeons are now stuck using a technique with a high failure rate to avoid a 10 percent risk of erosion.

 "It ruins my ability to take care of patients," says Dr. Neeraj Kohli, a urogynecologist in private practice near Boston. "I've reduced my use of mesh by 80 percent in the past five

 

 

 

 

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