Are barbed sutures safe?
Last week, a patient who had a TLH 8 weeks ago contacted me to complain about symptoms suggesting vaginal dehiscence following intercourse. Vaginal vault dehiscence is a rather uncommon surgical complication following hysterectomy. For my practice, I can only remember one other patient since 2003. Since I audit my outcomes through SurgicalPerformance I have not encountered a vaginal vault dehiscence.
My patient is in her fifties, she has a history of breast cancer and chemotherapy. I pulled the theatre notes. Her operation was straightforward. She had the vaginal vault closed with a V-Loc suture. V-Loc is a novel barbed suture that I really like because of its improved haemostasis. I also used Surgiflo on the vaginal vault to prevent a vaginal vault haematoma.
Recently, one of my colleagues changed from Monocryl to V-Loc sutures to close the vaginal vault after Laparoscopic Hysterectomy when it was launched a little less than a year ago. Two patients developed a postoperative bleed. Blaming the suture, he stopped using V-Loc after 2 vaginal dehiscences in a row. Another colleague – exactly the same story. Stopped using V-Loc after adverse events.
I looked up the company’s website. I was hungry for information on V-Loc and its outcomes. There is loads of info on the product and how to use it. Even a short 4-minute video with practical tips but absolutely no critical appraisal of V-Loc or any hint of scientific data, clinical trials comparing V-Loc with non-barbed sutures or any other scientific research.
I then looked up PubMed. As per this week there are 6 studies listed that are classified as clinical trials. Five of these studies are on surgery for prostate cancer and the use of V-Loc in suturing the vesico-urethral anastomosis. One paper is available on myomectomies (less blood loss with the barbed V-Loc suture compared to a historical control).
Desperate, I phoned Covidien. Jodie, a very helpful rep sent me a list of abstracts from past AAGL meetings. None of these abstracts can be considered "published evidence".
Within those there was one paper, a retrospective audit of 387 patients who had surgery within a 4-year period. Retrospectively, the authors compared barbed sutures with non-barbed sutures for laparoscopic vaginal vault closure. Barbed sutures had a 0% vaginal dehiscence rate (compared to 4.2% in the non-barbed sutures). Barbed sutures were also associated with a lower incidence of postoperative bleeding, formation of granulation tissue and cellulitis. The type of barbed suture was undefined. The study was retrospective, suggesting that the whole department switched form "what we used" to barbed sutures at a certain point in time. As we all know, retrospective series are not useful to compare one treatment with another as any treatment is subject to bias. A randomised trial is the only way to compare two interventions.
OK, I thought, maybe the competitor’s product Quill from Johnson&Johnson will have more info. The search for "Quill" resulted in three studies: One on sheep, one on rabbits and one on pigs. Apparently, on these animals, Quill (in the 2.0 strength) is as strong as a 2.0 monofilament PDS or Monocryl suture. Again, there is not a single trial on vaginal vault closure.
Very disappointingly, there is not a single randomised trial on barbed versus non-barbed sutures for vaginal vault closure worldwide. For Heavens sake! Who actually protects our patients in this country? Is it ethical to sell product to us so that we use it on our patients even if there is a total lack of supporting research documentation?
There may not be any difference in suture quality between barbed and other monofilament sutures. Or is there? What if new sutures actually do have an increased risk of surgical complications and patients need to be taken back to the operating theatre to fix it? Who is liable?
- Is it the device company that sells the suture without any documentation supporting its use? I guess from a device company point of view it is more cost effective to sell this stuff to hospitals and accept a class action from time to time (as currently seen on Meshes) rather than provide research data.
- Is it me? The surgeon who uses surgical suture material that is approved by Government authorities?
- Or is it the Therapeutic Goods Administration (TGA) that approves devices for the use on real patients. How come that novel sutures are not rigorously enough tested before they are implanted into patients?
Take a moment and compare it to medicines: Would anyone really accept to ingest a novel medicine without prior rigorous testing? Before being reimbursed by Medicare all medicines need to show that they are efficacious (that they actually do what they promise to do and that they are safe). I cannot see that in regards to vaginal vault closure tests for patient safety (surgical complications) were completed to an acceptable standard unless there are data available to TGA that are not available publicly.
Will TGA consider commenting as to why devices get different treatment compared to medicines?
Have you, dear reader, had any vault dehiscences that you would like to share with us?
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Comments
Dr.Thomas willium 01/01/2014 1:06am (10 years ago)
very bad suture
Dr.Thomas willium 01/01/2014 1:06am (10 years ago)
Very bad suture .there is no basic differene between traditional one.
Andreas Obermair 13/05/2013 5:14pm (11 years ago)
They will have not a problem getting any new suture through TGA. They will just argue that the new suture is like any existing PDS suture. In the past TGA has always ignored the possibility that the physicality of the suture might impact on outcomes, which is unfortunate. Unless companies volunteer to provide data on the safety and efficacy of their products, I cannot see how safer surgical devices can enter the market in the short term.
Carl 10/05/2013 1:18pm (11 years ago)
I wonder whether the issue is more technique related rather than the suture itself. Because it is unlike suture we have used previously it seems logical that a different surgical technique is required.
A 'normal' running suture can equilibrate tension throughout the suture line to allow for tissue oedema post op by sliding through the tissue. A barbed suture however will remain at the tension set by the surgeon and can't slide through tissue to equilibrate tension as well. Therefore as oedema develops post op it will become more ischaemic resulting in poor quality healing, predisposing to dehiscence.
My thoughts are to be very careful when setting the tension on the stitches and avoid using the suture to pull up on your suture line for the next stitch. Leaving it relatively loose rather than pulling really tight might decrease the chance of this complication.
Have you heard that Ethicon is about to enter the market with Stratafix? They are even releasing a PDS version specifically for laparotomy closure. I don't believe there are even case reports with it being used for this indication.
Andreas Obermair 27/02/2013 12:01pm (11 years ago)
I saw another patient yesterday afternoon. She has a history of breast cancer for which she had chemotherapy in the past. Had a TLH mid last year, with V-Loc vaginal vault closure. She had a vaginal vault dehiscence 4 months later. Very unusual. In the total absence of data - Is it all just bad luck for V-Loc or do we have an issue with the safety and efficacy of V-Loc.
Kelvin Larwood 21/02/2013 4:10pm (11 years ago)
Very good article and good points you make. I think we need to enguage industry as they play am important role in developing products that can help our patients.
When new products become available we need to review the evidence and if there isn't any be part of the solultion by using the product only on the bases that it is part of a formal audit/study with results that can be made public (good or bad) which can then guide our clinical use of these devices.
Periklis 11/12/2012 8:22am (11 years ago)
Hi Carole,How well you have described your eeiprexnce. Your emotions are so plain to read and I think many of us who have lived with fear of cancer and have endured not only the surgery, pain and discomfort but also the embarrassment indeed humiliation of it all. I am 61, had a vaginal hysterectomy and repair in Jan this year due to prolapse. Had problems with my bladder, but that has recovered quite a lot. Similar prob with my bowel movements, I think it's normal but I'm suddenly realising that I have reached the age when I want to discuss prunes with people! 17 years ago I had a mastectomy because of breast cancer. I now feel I am a one breasted, womb less woman! that is in the moments when I feel a bit sorry for myself. I have to keep telling myself that I am a child of these sixties and will continue to dye my hair blonde and wear probably unsuitable clothes for my age! I go back to work tomorrow after 12 weeks. I'm quite dreading it, but I suppose after a few days I will again back to normal and hopefully this episode in my life, will fade eventually and I will continue to moan about the mundane things in life. One or two good things to come out of it is that I have survived, didn't let myself down and have learnt, from this website, how brave and amazing we are. Take care and wishing you a good recovery.
Andreas Obermair 26/11/2012 5:33am (11 years ago)
It would be very easy to design a study on vaginal vault suturing because the primary endpoint does not require long follow up. Therefore such a study would also not be very expensive.
A colleague I operated with recently suggested that we collectively abstain from using "unproven" medical devices (e.g., mesh, barbed sutures, adhesion barriers, haemostatic agents) until they are properly tested. When I speak to the company reps, they also suffer. They are embarrassed that they have to come and see me, hoping to sell product to me without data.
We only would need to hope that we become so many that the pressure on the headquarters in the device companies becomes so big that they do support clinical trials on the products they are keen to sell.
Martin Rudnicki 23/11/2012 4:48pm (11 years ago)
During the recent period I have discovered several problems with barbed sutures, just as you described. I introduced the sutures as they looked very easy to use, but as you describe we observed several patients having postoperative bleeding and especially vaginal dehiscence, in the beginning several in a row. Accordingly, I stopped using the sutures, and went back to Vicryl.
I find it very problematic that it is possible to develop a suture without exact knowledge of the strengths of the suture, and whether there is any specific problems associated with the sutures. Maybe, we should define criteria for a prospective study?
Best regards
Martin Rudnicki
Ass. professer
Dept. of Obstetrics and Gyneocology
Roskilde University
Hospital
Denmark
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