Dr. Wei Talks (continue) Part 2

Jul 12th, 2012 | By | Category: Medical News

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. #

 

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11 Comments to “Dr. Wei Talks (continue) Part 2”

  1. Amy G says:

    Wow pretty lame answers!

  2. Amy G says:

    He can’t answer that? There is a 50% chance you may develop urinary leakage after prolapse surgery and we would like to put a permanently implanted device that has been reported to erode and cause chronic life altering pain reported at 50% and 30% respectively. With many adverse events not occuring until 3 or more years post operatively it will be highly unlikely we could remove the device completely and without risk. There are a few specialists with experience in TVT removal after it has scarred in so you should set aside funds so you can travel to one of these specialists as it will be expensive especially if your insurance considers it “out of network”. You may be placed on disability, contemplate or commit suicide from the pain, you may remain so unable to leak urine as the scarring obstructs your urethra, you may possibly need to cath yourself several times a day. As the inflammatory process intended to support your organs never subsides you will continue to form adhesions which can tug on your lower pelvic muscles creating severe debillitating pain for some.

    And to this Dr. Wei, you say you can’t answer if the risks are worth the benefit?

  3. Amy G says:

    It seems Dr. Wei’s findings are incongruent with other research

    http://www.springerlink.com/content/kn412382526k3h2l/fulltext.html

  4. Caitlyn says:

    The issue here is that the women to which this study refers are usually not incontinent or have very mild or infrequent symptoms – they are informed at the time of prolapse surgery that they have hidden stress incontinence which will be a lot worse after prolapse surgery when in fact they may not even need to have a sling in half of the cases! As Amy says, you are introducting an unnecessary risk. If the women wait 6 months or a year after prolapse surgery they can then evaluate their SI situation and THEN decide if the benefit outweights the risk not before.

  5. Amy G says:

    HIs own study states for 1 woman to benefit 6.3 women will receive this sling needlessly or may develop incontinence in spite of the sling (? causation) International research demonstrates 10 women will receive the sling needlessly for only 1 to receive a benefit. Realizing these devices are paid for by tax dollars for medicare/medicaid recipients with complications treated adding to the expense this is not a wise use of money as the sling addition is billed as a seperate procedure from any hysterectomy, A & P repair, or rectocele repair. Every attorney generals office in this country should be advised of the egeregious waste with the indiscriminite use of these slings.

    • Caitlyn says:

      Yes, Amy, similarly it seems very wasteful for the UK’s National Health Service to pay several hundred pounds for a device which is implanted inside a woman who (a) might not actually need it and (b) might suffer from complications and harm from such a device therefore incurring further potentially unnecessary costs to the NHS. As you say in America, “Go figure…”

  6. Amy G says:

    Is Dr. Iglesia’s comment “albeit non-serious” her words or yours Jane?

    • Jane Akre says:

      Absolutely her words… that’s why I put them in a quote. Really, she knows better. She was called into the expert panel to listen to all of the meshes gone wrong.. No one there said their injuries were non-serious!

  7. anurse says:

    Recently I have been trying to help a lady in her early thirties, with a two year old child. She has horrible pain and has been unable to urinate since last June when her SUI MESH was inserted. She had one of the J&J mesh kits that are being removed from the market but that remain on shelves and in use. She has already had the mesh removed in more than one surgery by the same surgeon who put it in and has since been told by him that he doesn’t know why she still cannot urinate. Another group in town that she saw, desperately trying to seek answers, told her that they don’t want to see her anymore…. that she needs to go back to the first surgeon. I guess they don’t want to deal with someone else’s “problem”, a very familiar scenario for many mesh injured people. Now I’m hearing something about a possible “dead bladder”! Does this mean a “neurogenic bladder”? All this young lady wants is for her pain to go away and to be able to pee normally again! The FDA’s OB-GYN Panel found that SUI meshes are safe and effective?, “albeit non-serious”? Please tell that to this unfortunate young lady. Better yet, HELP HER NOW! She NEEDS your help NOW!

    • EH says:

      Hey, this is so sad and all too real! I had the same thing happen. After over $3000 worth of tests he decided to send me back to original surgeon. He must have talked to the medical community during the week. This is so absurb. I couldn’t pee either and was told many lies. Such as this is normal. I have not heard of a “dead bladder” but now will have something else to look up. SUI meshes are not safe and effective. They are life style killers as well as real killers. I’d like them to try this for awhile – implant a small amount of mesh into the muscle layer near any joint or nerve. I’m sure it would be a fun experiment. We went in for a “minor” procedure and came out maimed for life!

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