I stopped using V-Loc this week

Tagged V-Loc, vaginal closure; Comments 3 ; Posted 11 years ago

When I trained with Tony McCartney in Perth, we used an ordinary monofilament suture to close the vagina after a TLH. The suture was introduced through the transvaginal tube into the pelvis; we started suturing at 4 o’clock and did a continuous suture from the right to the left and backwards. Once finished we exteriorised the needle to tie the knot against the vagina.

Some mishaps happened occasionally. Less than once a year the anatomy would be so distorted that the indwelling catheter would get caught in the suture in which case we had to undo the suture and start again. One of my colleagues even managed to involve a minor labia in the suture and the patient had to be taken back to theatre. There were hardly any other problems.

Vault haematomas happened occasionally but they were mainly of an infectious nature. Those dehiscences / haematomas usually developed within the 6–weeks postoperative period. Hardly any patient had to be taken back to theatre. Almost all of these patients could be treated conservatively with antibiotics.

Then came the V-Loc. A couple of years ago this new barbed suture was introduced and marketed by Covidien. Covidien did not have to sell it hard to us. What a convenient suture. Much shorter than the full-length Monocryl. No need to tie a knot.

V-Loc is a barbed suture that is essentially a Maxon suture, except it is barbed. The barbs essentially minimises that the suture slips back. It does not need to be tied, which not only I found very helpful.

Like all other sutures, the V-Loc gets introduced into the pelvis through the tube. You start at the right vaginal angle and continue as a running suture from the right to the left and backwards if you wish to.

The next thing that I became aware of was the two of my colleagues who switched to the V-Loc, actually switched back and away from the V-Loc after they had a couple of vaginal vault dehiscences.

At the time I did not encounter any vault dehiscences and thought to myself  that we all go through vaginal vault dehiscences occasionally. Hence, I continued using the V-Loc.

Shortly after I had two cases with vault dehiscences in a short sequence. It was characteristic of both cases that they developed several months after surgery. One of those patients had chemotherapy for breast cancer previously and I thought that the delayed wound healing from her chemotherapy might have contributed to that isolated case.

What broke the camel’s back was another two of those delayed vault dehiscences. In one case my patient had a TLH 6 months ago. I saw her 2 months after surgery, examined her and her VE has shown a completely intact vaginal vault. Four months later, she presented with a total vault dehiscence. She presented to another hospital with omentum eviscerating from her vagina. She required a laparotomy, involvement of an urologist and a general surgeon, omentectomy and vaginal vault closure. Another patient who had a TLH in August presented with a vault dehiscence in November. That’s too much.

I am not sure what the mechanism of the vault dehiscence is in these particular cases. It seems that all these vault dehiscences develop many months after surgery and all of those patients required surgery to fix the problem.

I can hear some colleagues saying that I tied the suture too hard, etc.  These are excuses. I am not aware of any study comparing how hard one is supposed to tie a suture.

In fact, I am not aware of any study that would have V-Loc formally tested for safety or for efficacy prior to registration with TGA.

V-Loc gained registration because Covidien claimed that it is extremely similar to an existing, registered suture; it apparently represents a minor modification only from an existing and registered TGA approved surgical device. The government authorities unfortunately never considered the physicality of the suture and its potential consequences.

I shared my concerns with Covidien. Covidien was not concerned. Prospective data were not available. Retrospective data that were available did not suggest an increased risk of adverse events using V-Loc. The complaints rate to Covidien was far less than 1% of product used.

The Therapeutic Goods Administration (TGA) deflects the responsibility of adverse events reporting to the individual surgeon. I attempted to report my failures with V-Loc but gave up midway. TGA makes it so difficult for surgeons to report adverse events, that this process is completely infeasible.

Many more gynaecologists will use V-Loc or any other barbed sutures for vaginal closure. And many more women will develop vault dehiscences for which they need to be taken back to the operating theatre for re-suturing.

Not only in Australia but worldwide we have an issue with testing and evaluating surgical devices. The current system of not-testing will continue to create significant preventable and costly harm to patients and society.

Surgical device companies can only hope that those individual patients who experienced adverse events don’t connect with each other and submit legal claims. This is exactly what happened with mesh devices in pelvic floor surgery, breast implants and faulty hip prostheses previously.

On Monday this week, I switched back to use the old monofilament suture again for vaginal vault suture. No more V-Loc for me. I will keep you posted. 

If you made similar experiences with V-Loc, you can share them with us here. 

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