Adding my two cents to the mega mesh mess surrounding transvaginal mesh complications…

FDA warns there is NO evidence that mesh provided any greater clinical benefit than non-mesh surgeries

FDA3Many doctors and advocates for the use of mesh continue to promote using surgical mesh for pelvic repairs, routinely telling people that,

Without mesh, surgery often fails in one to five years because our tissues are not strong enough to hold the repair long term.

~  Sherrie Palm,  Founder of APOPs (Association for Pelvic Organ Prolapse Support), and author of  “POP MESH SURGERY: TIPS FOR THE BEST OUTCOME

So, I am asking yet again – is this true??

Do surgical repairs using mesh last longer than repairs using your own biological tissue?“.

If yes, WHERE are the actual medical articles/studies that show that mesh lasts longer than surgeries without mesh?  I’m asking because the The FDA warnings specifically state the opposite of what APOPS, and others, claim.
The FDA warnings stated:

“there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries”

The FDA also warns that people should be told that IF they use mesh, there is the “ADDED risk of mesh erosion”, and the severe mesh complications that go with that.

Please see the following FDA publications for details:

  • FDA: “Concerns about Surgical Mesh for POP“, where the FDA states, “Based on an updated analysis of adverse events reported to the FDA and complications described in recent scientific literature, on July 13, 2011 an FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse was issued to inform the medical community and patients that: serious complications associated with surgical mesh for transvaginal repair of POP are NOT RARE; and it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repairs.

  •  FDA: Information for Health Care Providers for POP”, indicating doctors should

    • Consider these factors before placing surgical mesh:
      • Recognize that in most cases, POP can be treated successfully without mesh.
      • Surgical mesh is a permanent implant that may make future surgical repair more challenging.
      • Having a mesh surgery may put the patient at risk for requiring additional surgery or for the development of new complications.
      • Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
  • FDA: “Information for Patients for POP“, where the FDA states, “It is important that women are aware of the risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP). Women who have mesh surgery may be at risk for needing additional surgery due to mesh-related complications“, and more.

  • FDA: Information for Health Care Providers for SUI, indicating doctors should insure patients understand treatment options (including non-mesh surgery), potential complications (including the added risk of erosion for mesh repairs), to convey that a mesh sling is a permanent implant,  and that there is limited information about outcomes after one year.

  • FDA: “Information for Patients for SUI“.  where the FDA suggests that patients ask their doctors about treatment options, including non-surgical options, and surgery without mesh.  They warned that mesh had the added risk of mesh erosion which could require additional surgery and cause “penile irritation and/or pain during sexual intercourse” for sexual partners.

  • And, in the FDA’s page titled, “Considerations about Surgical Mesh for SUI” notice, they said a lot – including that there’s an “approximate 70 to 80 percent success rate of women at one year” (as if 20-30% failure is good?!?), and that the use of mesh slings in transvaginal SUI repair introduces a risk not present in traditional non-mesh surgery for SUI repair, which is mesh erosion.

I do agree with Sherrie Palm that we need to raise awareness for these issues, and completely agree with her statement when she said;

You should hear both sides of the story, risks and benefits, in order to be fully informed to better enable you to make the most appropriate decision whether to move forward with surgery.

Yes.  Please.  HEAR BOTH SIDES.  And, that includes reading the FDA warnings, and seeing actual research, and maybe even (God forbid!) listening to some of the hundreds of thousands of women who HAVE been injured by mesh.  Please do NOT just take advice that contradicts FDA warnings, especially from someone who is not a medical professional, and/or without giving any actual research or medical studies to back up their advice.  

There is WAY too much  misinformation out there.   Much of it is generated by the mesh manufacturers themselves, who’s main goal is more likely the SALES of their mesh products, rather than your health.  

Please if you, or someone you know, is considering surgery for POP or SUI, please see THIS article first, “Top 10 Things to Know About Mesh BEFORE Having Surgery for POP or SUI“, which has links to FDA warnings and more.  Thank you.

==============Related Mesh Me Not Blog Posts================

FDA

Tagged as: , , , , , , , , , , , , , , , , , , , , , , ,

Categorised in: FDA, Mesh Complications, Pelvic Organ Prolapse, Sales & Marketing

14 Responses »

  1. Thank you Deb…. this is such an important reminder. Still, women are not being told this information, especially as it pertains to incontinence mesh, which the FDA has not adequately addressed. Doctors, are you listening? medical schools- start training doctors in non mesh repairs again!

    Like

    • Thanks Jane. I wish more WERE listening! I really don’t understand why organizations like APOPS, and others, are getting away with making claims that mesh lasts longer, when the FDA warnings state the opposite. How can they keep saying things, without giving any evidence to back up their claims? They say they want people to make their own choices and educated decisions – but, then they give them FALSE information or NOT real information. That is not being supportive. It’s being misleading.

      Like

  2. YES + I AM A HUSBAND OF ONE OF THE VICTIMS-OF SURGERY GONE REAL BAD AND I HAD TERRIBLE PAIN TO MY PENIS DURING INTERCOURSE & OUR SEX-LIFE WAS DESTROYED FOREVER…THERE SHOULD BE A LOT MORE LAWSUITS AGAINST THESE MESH COMPANIES THAN THE 1000″S THAT ALREADY HAVE !!!!

    Like

    • Thank you for leaving a comment here, James. I have heard of other men finding out the hard way that the mesh had eroded thru their partner’s vaginal wall. Considering the mesh hardens from that cushy gauze they show you beforehand, into a hard, window-screen like consistency with rough edges – I can only imagine how horrific this truly would be. People have no idea. You would think the thought of this very REAL possibility would be a bigger concern and consideration for most to NOT use mesh…. but, instead, you do not hear much about this. Probably because men don’t go into these groups/forums as much, and it’s not something easy to share or discuss…

      Like

  3. I am 2 weeks down the line from having a polypropylene mesh repair to a very rare lumbar hernia in my back which had some of my bowel in it. I was told I’d be given a number of local anaesthetics to the area before I woke up (meshis about 16cm by 16cm) close to my ribs, spine and hips. I awoke thinking I had gone to hell, every breath, even the shallowest was purgatory, I could not even speak for the pain. I was given more and more morphine till they said my pupils were like pin points and they stopped giving any more pain relief, my husband tells me I was howling like an animal, clearly in agony and spouting all sorts of nonsense.

    My pain has subsided a fair bit in my stomach from this surgery but I am experiencing stabbing pains in my rib, back and hip area and decided to look at possible problems with the mesh on the net. I found your site and it scares me that this stabbing pain (which is completely different from the first 10 days of postop pain) could be due to the mesh.

    Has anyone had the same op as me with or without mesh who is able to advise me how long till I am pain free? I have had other major surgeries, mastectomy with Lat Dorsi reconstruction, 4 and a 1/2 inch rotator cuff repair with biceps bone transplant repair and lower lumbar spine repair to 3 discs so I have had some bad post op pain before but never as bad as this was. I’m not a wuss!

    I’m hoping it’s not the mesh that’s stabbing me inside as this is a big area of it I have so how would they ever get it all out? It’s stapled with titanium to various muscles. Rather worried to say the least. Guess what, I asked if there are any complication with the mesh and was told no, none, and I am a person with other allergies.
    Thanks folks. X

    Like

    • Carole –

      I’m so sorry. That sounds like hell. =( I would not be surprised if the mesh is a factor, and it amazes me that people are STILL being told today that there are NOT mesh complications. I do not have hernia mesh, but have talked to many who do… and it is made of the same material, and causing the same kinds of problems (erosion, infection, etc.) There are doctors who specialize in hernia mesh complications, just as there are a few that specialize in pelvic mesh. But, they are not always easy to find. Seems most docs do not want anything to do with it, and/or really don’t know much about it.

      You may want to talk to folks in this group, for people with hernia and TVT mesh complications: http://www.everycup.com/mediadetail/23799998?

      There’s also an Open/Public group for anyone and everyone at:
      https://www.facebook.com/groups/meshproblems/

      Hang in there… and keep searching for answers. ❤

      Like

  4. “According to a Cochrane review presented at the International Urogynecological Association’s 2012 annual meeting, studies have not uncovered a clear advantage of anterior compartment mesh utilization over anterior repair (colporrhaphy). Nor is transvaginal mesh better than native tissue repairs in apical or posterior compartment prolapse, and mesh also carries with it an increased risk of intervention in the short term, the team concluded.”

    From:
    http://www.renalandurologynews.com/urology/few-pelvic-organ-prolapse-procedures-show-edge/article/261789/

    Like

  5. I completely agree with this. I had some contact with Sherrie Palm and she is a well meaning, passionate, kind lady who just wants to raise awareness of the hidden issue of POP. BUT, she does have a voice in this field, and it is sad and wrong if her posts encourage people towards mesh surgery when the truth is the risks are unacceptable high.

    Liked by 1 person

    • Thank you. That is all I’m saying. Go ahead, and raise awareness… but, give people ALL the facts when it comes to option. Give them the TRUTH about mesh. Let them hear the warnings, etc. It’s not right to make claims that are NOT warranted, or proven to be true (like, mesh lasts longer, etc.).

      Like

  6. How about this article, published in the International Urogynecology Journal, titled “Systematic reviews of apical prolapse surgery: are we being misled down a dangerous path?”
    It has to do with the claim of superiority of sacrocolpopexy (SC) over other pelvic organ prolapse (POP) procedures, which included:

    “The addition of mesh, whether abdominally or vaginally, does not universally result in definitive cure of POP and the risk of mesh-related complications CONTINUES INDEFINITELY. Systematic reviews of risks associated with the use of mesh in POP surgery indicate that mesh procedures (SC and vaginal mesh) result in lower rates of reoperation for recurrent prolapse, but have higher reoperation rates for complications, resulting in a higher total reoperation rate with mesh than with native tissue repairs [20, 21].”

    Here is the article as posted online at: http://link.springer.com/article/10.1007/s00192-015-2733-6/fulltext.html

    Like

Trackbacks

  1. Mesh-Injured People: NOT rare. NOT going away. NOT getting SUPPORT! | Mesh Me Not
  2. AUGS Prolapse Consensus Conference Announced - Mesh Medical Device Newsdesk
  3. Is it ok to jump right into “minor” surgery for SUI? – Mesh Me Not
  4. Scaremongering or Just Plain Scary? – Mesh Me Not

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s

Appreciated Visits:

  • 181,376 hits
%d bloggers like this: