On July 13, 2011 the FDA issued a Safety Communication (here) which says: 

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

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.

The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

Dr. John Wei, urologist, U of Michigan

Dr. Wei continues from Part 1 (here)

Q: The FDA has posted warnings that the benefits of mesh may not exceed the risk, are you aware of that?

“I’d say I agree with the FDA. I say they are doing a good job. There are two levels of concern at the FDA right now.  Right now the emphasis is on vaginal prolapse mesh.

 

Q: I can tell you, many of the women I talk to say they didn’t get the information. They were told it (mesh, slings) will fix you right up, no problems.

“That makes me uncomfortable. Some doctors don’t do a good job explain risks and benefits.  This (study) should help.  All a doctor has to do is pull out our paper. It actually can help terms of counseling. It’s used to guide to make informed decisions.

 

Q: Have you heard of the ‘clean contaminated’ field that Dr. Margolis testified to the FDA was the situation with introducing mesh through the vagina?

“I could tell you many example of clean contaminated in medicine all the time which we can get away with in the sense of having fairly low complications.  A colonoscopy is recommended when we hit age 50. We’ll take off polyps.  Is it clean contaminated? Absolutely! Is it safe? Yes, better than through the abdomen so yes, we do clean, contaminated all the time.”

 

Q: But you don’t leave something in there.

“That’s correct.”

 

Q: Are you aware of the 510(k) process for medical device approval?

“Yes, I do understand that point. The FDA requirements for drugs are more stringent than for new devices and technology. Over time the FDA policy will change because of the attention of mesh.

“There is a tradeoff between progress and doing the studies that will give you the evidence of efficacy side and the side effects side. If you demand all new drugs and technology go through the process of five years to prove it doesn’t harm and nobody dies, nothing will make it out.  It’s so expensive and takes so long to do.  So it’s a trade off.  You have to do an OPUS trial before you do something because takes too long what will happen? Women may be missing the benefit they could have. That’s the tradeoff.

“I’m sure we’ll come to some balance right now we’re all struggling.”

 

Q: How many slings do you put in prophylactically?

“No I’m a urologist, I work in a network of gynecologists. I’m unique in the network in that I don’t put in these slings.  When we wrote this grant we had to come up with an idea for a trial and I came up with this idea; it was my brainchild.  We listed everyone’s project within our group and they chose this study to do.

“It’s science at its best not based on politics, it’s based on what think important.”

 Your Questions were posed to Dr. Wei:

 

Q: Peggy D. says:“I still rue the day, 5 years ago that I let a gynecologist talk me into an unnecessary sling to prevent “future incontinence”. The sling was placed wrong and I had to suffer through 4 months of excruciating, debilitating pain, incomplete evacuation of my bladder, and difficulties urinating at all. I endured the most painful procedures as several doctors tried to sort out what the problem was. I was reduced to assuming humiliating positions to accomplish the dreaded task of urination and it remains that way to this day.I suffered through another surgery for a partial removal of the superfluoussling. I was left with a painful neuroma from one of the surgeries, still have the difficulties urinating and the constant pain. It sure has made me give up on doctors completely — and I’m a retired nurse. I’d rather die a natural death than allow them to humiliate, harm me, hurt me or just plain kill me outright.”

Dr. Wei: “I’m sure she is not a unique case as complications, even bad ones, do occur at a finite rate. As healthcare providers, we have to assume that if we are going to treat patients, then there will be a possibility of side effects.  Let’s say I perform surgery for leakage of urine, and while we successfully treat the leakage, the patient develops a stroke, and becomes paralyzed. It can happen. While it is impossible for providers to explain all possible complications that may happen, the most common ones should be explained.  Once you do that for patients and they understand it, there will be less regret.  A problem arises when the patient’s expectations aren’t where they should be.

“To say ‘I’ll fix you, guaranteed,” or similar statements are just wrong.

“My comments probably provide little solace for Peggy D who has experienced a terrible complication but her story should remind all of us, as consumers of health care, to try to be as educated about the care we are getting before accepting it.

“In the OPUS trial, there was a secondary analysis to see who might benefit more from a  midurethral sling based on a preoperative cough reduction stress test. At 3 months, women with a positive test appeared to benefit from a sling more than those with a negative test. However, this effect was no longer evident when the patient was followed to the 12 month time point.”

 

Q: Amy G says:

You might be continent with mesh surgeries- nearly 1/4 of the women with slings still developed incontinence. Doesn’t seem worth the risk for essentially only 1/4 of the women saw any benefit from the device. Slightly less than 1/2 of the women went on to develop incontinence in the non-sling arm-meaning this is a fairly weak argument in support of prophylactic slings.

A 25% chance it will be of any benefit does not seem like a worthwhile risk for taking on a device that could prohibit any sexual relations and result in crippling pain, urethral obstruction and multiple re-operations (just to name a few risks)

Dr. Wei: “That’s her opinion and she’s entitled to that. I’d say ask women who didn’t get a sling and she’s now enduring the leakage.  Is the 25% worth the risk? I can’t answer any of that it’s a personal value judgment.  I’m not making a value judgment. “

Q: Ruth says:

One of the (many) things that bothers me about this trial is that any “cost-effectiveness analysis” fails to factor in the incalculable human cost in terms of human suffering and destroyed lives which often develop much, much later than the 12 month follow-up period of this study.

Dr. Wei: “Our study does end at 12 months,” we did not do a cost effectiveness analysis I can’t speak to that.

“Do you do the cough test- it’s the doctor’s attempt to try and tell women who will leak. I don’t do surgery on female leakage. I’ve never put in a sling. That makes it fair for me to run a study because I can be very objective. I think you have a good sense of issues here.

“My take home message – The trial did something which will be valuable which expressed for women in concrete numbers the side effects and benefits of putting in the sling. We articulate why that is rational. Ultimately it’s up to the patient. I think our paper should help make that paper more concrete.”  #

 

Editorial in NEJM by Cheryl B. Iglesia, M.D. “Vaginal Prolapse Repair – Place Midurethral Sling Now or Later?

Cheryl B. Iglesia M.D.

Dr. Iglesia was a panelist convened by the FDA last September to revisit the number of patient injuries from synthetic mesh used for POP and SUI. In this editorial that accompanies the OPUS trial, she reminds us that between 2008 and 2011, the FDA noted an increase in complications including vaginal mesh erosions, infection, pain, bleeding and dyspareunia (painful sex). As a result the FDA convened an expert panel which “made a clear distinction between slings – that is, synthetic mesh straps 1 cm wide and an average of 10 cm long that are placed beneath the urethra – and the much larger sheets of synthetic mesh (up to 10cm wide and 20 cm long) that are placed in the vagina to support prolapse organs, such as cyctoceles, rectoceles, and uterine prolapse.”

She continues, “On the basis of findings from multiple randomized trials as well as observational studies with more than 11 years of follow-up, the committee concluded that midurethral slings were safe and effective.”  Because of the shortage of data regarding POP repairs, the panel recommended postmarketing studies to assess the safety and effectiveness of transvaginal mesh for prolapsed repair. Similar studies were not ordered for slings to treat incontinence.

So she concludes in making a choice to use a sling prophylactically, “should be based on the current evidence that slings reduce the risk of new incontinence but may pose some inherent (albeit nonserious) risks.”

If a woman is incontinent, then the benefit will probably outweigh the risks, she concludes. #