人工矽膠隆鼻的長期追蹤--美國整形與重建醫學雜誌2007年12月專題摘要

Gross and Pathologic Analysis of Long-Term Silicone Implants Inserted into the Human Body for Augmentation Rhinoplasty: 221 Revision Cases.

221例矽膠隆鼻後的長期追蹤

Plastie and Reconstructive Surgery December,2007

摘要:

目前大家所知道的,隆鼻所用的矽膠本身是安全的,然而本研究的目的,是在於隆鼻多年之後,鼻子組織對矽膠的反應與變化.研究的對象,是曾經以矽膠隆鼻的患者,於再次修改隆鼻手術或取出矽膠的時候,藉著這個機會,研究矽膠周圍組織的變化.

方法:再次做鼻子整形的患者之中,共計取出221支隆鼻用矽膠,這些個案隆鼻的時間,從一個月到25年不等,平均6年7個月.取出矽膠的同時,鼻內組織分別以肉眼與顯微鏡檢查其變化.

結果: 肉眼可見到鼻內組織鈣化的平均時間約為矽膠隆鼻後5年8個月,以顯微鏡檢查則發現,早在矽膠隆鼻後4年,就可見到鼻內組織鈣化現象.矽膠隆鼻超過9年後,有50%患者產生鈣化現象.超過15年之後,則除了鈣化之外,也發生變形.矽膠植入的早期,顯微鏡檢發現,plasma cell, macrophage, 以及neurtophil增生的炎性反應與鈣化現象,晚期則產生淋巴球增生的炎性反應.

結論: 矽膠隆鼻長期追蹤後,發現會產生鈣化現象與鼻內組織形狀的改變,建議選擇以矽膠隆鼻的時候,應該將此現象列入考慮.

討論區:

回應

問:

矽膠隆鼻長期追蹤以後,有可能會在週邊產生鈣化現象,請問矽膠製的人工軟骨來墊下巴,是否也可可能會產生同樣問題嗎?

答:

不只是矽膠,其他任何人工植入物,都有可能會引起,圍繞植入物四周組織的反應,而形成鈣化現象。譬如因為下巴骨折,復位後以鋼釘固定,將來鋼釘周圍,就有可能形成鈣化現象。

即使沒有任何植入物,人體受傷產生血腫之後,也有可能於局部形成鈣化點或是硬塊,但是對身體無害。

植入物所導致的鈣化現象有害嗎?既然這是人體自然的修補現象,不算是副作用。只不過,如果發生在以矽膠隆鼻之後患者身上,因為鼻子皮肉較薄,比較容易被發現異狀,而且有機會造成鼻樑歪曲現象,因而須要取出人工鼻模。如果發生在下巴,因為下巴肉較厚,極不容易被發現這種問題,所以須要取出植入物的機率,微乎其微。

張醫師

問:

張醫師 你好我做過矽膠隆鼻 所以看到您這篇文獻翻譯後十分擔心鼻內組織鈣化現象 於是在網路上查找了這篇文獻的英文原版 原文似乎是在討論'矽膠植入體'的鈣化而不是鼻內組織自身的鈣化?我只是想搞清楚自己的疑問 因為我自己也有做隆鼻 矽膠鈣化的話還有取出重新做的可能 但是鼻內組織鈣化聽起來好像很嚴重 感覺鼻子多年以後就會壞掉一樣 我很擔心 希望您能解答我的疑慮 另外如果修整鼻子是否找第一次隆鼻的醫師做比較好?因為該醫師更了解第一次的手術? 謝謝!

答:證據會說話,我們先看看下面這兩張圖片

圖一:這些都是曾經以人工矽膠隆鼻後,重新手術時,手術取出的矽膠鼻模。

 

圖二。鏡頭拉近以後,放大觀察這些矽膠鼻模表面,年代久遠的鼻模表面,幾乎都會覆蓋一層厚厚的鈣化組織,這是矽膠鼻模周圍組織鈣化的結果。

在此簡單的回答所提疑問如下:

1.人工矽膠鼻模植入人體經年累月以後,產生鄰近組織的莢膜收縮、鈣化,年代久遠以後,甚至有可能導致矽膠本身也產生鈣化,這是正常的人體組織反應過程,不算是病態變化。

2.以人工隆鼻臨床多年追蹤的結果看來,約有超過95%以上案例,都可長年與人工鼻模和平共存,不須過度擔心。(近年來許多患者希望將人工鼻模取出,改成自體組織隆鼻,以獲得更自然的鼻形,則不在此限)

3.人工隆鼻以後,如果沒有發生感染,沒有明顯的扭曲變形,或是明顯的鼻樑變細現象,也沒有發現皮肉變薄的情況,則基本上沒有立即手術取出或置換鼻模的必要。

4.打算手術取出人工鼻模,如果在還沒有產生周圍組織鈣化的情況下,是簡單的手術,那一位整形外科醫師來進行手術,基本上沒有什麼差別,但是如果鼻模因為鈣化而沾粘於組織中,由經驗比較好的醫師,來進行鼻模移除手術,鼻子的皮下組織傷害較少,對於手術後鼻子形狀的維持,也比較理想。

5.理想的情況下,最好在移除人工鼻模的同時,經由鼻孔內切口,植入自體耳朵軟骨,對於絕大多數的患者來說,可說是一勞永逸的作法。

張醫師

在本診所鼻部整形手術之前,我們一定會要求患者口含消毒藥水漱口十分鐘以後,才進行手術.這樣的作法雖然已經行之多年,但是偶爾仍然會有患者問護士小姐:"為何須要漱口?"

我注意到這個問題的時候,還是整形外科住院醫師.當時上級指導醫師對於急診縫合的規定是:所有人咬傷急診的案例,一律不得縫合,原因是口腔內充滿細菌,縫合後容易感染,會使情況變得更壞.

但是當我實際擔任鼻子整形手術助手時卻又發現,患者口腔完全沒有消毒,手術中與醫師交談過程裡,不但可能噴出口水,擦拭血液的紗布經過口腔黏膜,甚至縫合過程中,縫線還有可能經過牙齒表面拖行-- 疑惑的是,口腔細菌不會增加鼻子感染的機率嗎?

心中既然存有這個疑問,升任主治醫師以後,就開始嚴格執行手術前口腔消毒的工作,果然大大的減少了術後感染的機率.

在一次國內美容外科醫學大會中,與會的專家們積極的討論假體隆鼻感染機率問題,發現進行開放式假體隆鼻,也就是將鼻子切開掀起來隆鼻手術的結果,術後感染的機率,比閉鎖式隆鼻,也就是經由單側鼻孔內切口手術者還要低,開放式隆鼻的切口,遠比閉鎖式切口要大,為何感染機率反而會更低?大家百思不解.

於是我舉手發言,告訴大家我的發現:原來進行開放式隆鼻,切口較大,所以大多數醫師都會進行口腔消毒;反之,閉鎖式隆鼻切口小,手術時間短,口腔消毒工作反而就被忽略了,這就是其間的差異.

我發言結束時,見到在場的同儕們頻頻點頭,顯然認同了我的看法,相信大家互相分享經驗討論的結果,對患者的安全更有保障,這不正是我們舉辦會議的目的嗎?

今天閱讀本期的Medscape,內科醫師與婦產科醫師超音波以及內視鏡檢查所使用的凍膠,居然被發現藏有致命細菌感染機率,美國食品藥物局特別提出警告,我們也將這一則最新消息,在此與各位分享,提醒大家的注意:

FDA Safety Changes: Ultrasound Gel Contaminated With Bacteria CME

News Author: Emma Hitt, PhD
CME Author: Laurie Barclay, MD

CME Released: 04/23/2012; Valid for credit through 04/23/2013

Clinical Context

Pseudomonas aeruginosa is typically found in water and soil, but when contacting the skin surface, it may cause inflammatory dermatitis, even on intact skin. If it is introduced to body sites where it is generally not found, such as the upper airway, the lower gastrointestinal tract, or the female genital tract, it may colonize or cause an infection.

Klebsiella are often present in the digestive tract without causing infection, but if introduced into the lungs or other tissues, serious infections could include pneumonia, wound infection, or sepsis.

Study Synopsis and Perspective

The US Food and Drug Administration (FDA) has notified healthcare professionals and facilities to stop using Other-Sonic Generic Ultrasound Transmission Gel manufactured June 2011 through December 2011 because of concerns about bacterial contamination with P aeruginosa and Klebsiella oxytoca.

According to an alert sent by MedWatch, the FDA's safety information and adverse event reporting program, contamination was found in lot numbers 060111, 090111, and 120111, which are lots that include 250-mL bottles and 5-L dispensing containers.

"This ultrasound gel presented serious health risks to patients, particularly vulnerable ones," said Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs. "Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health."

The gel is manufactured by Pharmaceutical Innovations Inc and is a nonsterile gel used in ultrasound procedures designed to assist transmission of the ultrasound signal from the transducer to the body.

According to the FDA, patients who have been exposed to these lots of Other-Sonic Generic Ultrasound Transmission Gel should be identified and assessed for signs of negative outcomes due to these procedures and evaluated further if necessary.

The safety communication notes that the FDA received a report from a hospital that 16 patients had developed colonization or infection with P aeruginosa. Each of these patients was examined with transesophageal ultrasound probes using Other-Sonic Generic Ultrasound Transmission Gel that was later found to be contaminated.

US Marshals, acting at the request of the FDA, then seized and tested unopened bottles of Other-Sonic Generic Ultrasound Transmission Gel at the reporting hospital and at the manufacturer's facility.

"The FDA's testing revealed that the finished product contained significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca," the agency states. "This result suggests that the source of this contamination occurred during the manufacturing process."

P aeruginosa is found most often in water and soil and can cause inflammatory dermatitis, even on intact skin. Klebsiella bacteria are often found in the digestive tract, where they do not often cause infection; however, potentially serious infections can develop when other tissues, such as the lungs or the bloodstream, are exposed.

Contact Pharmaceutical Innovations Inc at 973-242-2900 with questions and to report adverse events associated with use of the contaminated gel. The company notes that opened and unopened containers of the contaminated gel should be handled as biohazardous materials and disposed of by following the proper procedures.

Recommendations for Healthcare Professionals Regarding All Ultrasound Transmission Gels

The only ultrasound gel that is sterile is unopened, ultrasound gel containers or packets labeled as sterile. Ultrasound gel products that are labeled as nonsterile or that have no information in the label regarding sterility are NOT sterile.

All clinicians should review applicable policies and clinical practice standards to ensure that technicians, clinicians, and staff always use sterile ultrasound gel for those procedures requiring use of sterile ultrasound gel.

All clinicians should review the instructions for use, as well as hospital/facility policies, to assess whether sterile ultrasound gel is required for a particular procedure, or if nonsterile ultrasound gel is recommended for procedures using ultrasound transducers.

As recommended in clinical practice standards, all clinicians should use sterile ultrasound gel for all sterile body site procedures, as well as for any invasive procedures using ultrasound-guided biopsy.

Clinicians should use sterile ultrasound gel for procedures with mucosal contact in which biopsy is not planned, but in which any potential added bioburden should be avoided or in which mucosal trauma is likely. Examples of such procedures would include transesophageal echocardiography procedures, transvaginal ultrasound procedures without biopsy, and transrectal ultrasound procedures without biopsy.

Clinicians should realize that once a container of sterile or nonsterile ultrasound gel is opened, it is no longer sterile, and it may become contaminated during ongoing use. Opened containers of ultrasound gel should be used promptly for low-risk procedures on intact skin and for low-risk patients. The original container of ultrasound gel should be used and then discarded and should never be refilled or "topped off" during use.

Clinicians should review clinical policies regarding the handling of ultrasound gel products and should consider these recommendations when choosing the ultrasound gel product, size, and type.

More information regarding the warning is available on the FDA Web site.