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

By DebCNY • 2015/04/02

Many 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================

• Finding the Right Doctor for Surgical Mesh Complications
• Searching for Docs Experienced with FULL Mesh Removal, and/or NON-Mesh Repairs
• Partial vs. Full Mesh Removal Surgery
• Upstate NY Support for Mesh Complications
• Mesh-Injured People: NOT rare. NOT going away. NOT getting SUPPORT!
• It’s NOT enough. We need help!
• Are you a GOOD mesh? Or a BAD mesh?
• Were you told that you were the “only one”?
• FDA warns there is NO evidence that mesh provided any greater clinical benefit than non-mesh surgeries
• Top 10 Things to Know About Mesh BEFORE Having Surgery for POP or SUI
• Links to many other articles, blogs, support groups, and resources on the bottom of this blog

Tagged as: APOPS, Association for Pelvic Organ Prolapse Support, Bladder Prolapse, evidence, FDA, FDA warnings, marketing, Mesh, mesh complications, mesh survivors, no evidence, non-mesh, Pelvic Organ Prolapse, POP, proof, Research on Mesh, Risks, sales, sling, Stress Urinary Incontinence, SUI, tape, trans vaginal tape, warnings

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

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