FDA Warns of Symptoms of Mesh Problems

Aug 10th, 2011 | By | Category: FDA, Medical News

What to look for if something is “Not Right”

After initially calling problems with synthetic surgical mesh “rare” the Food and Drug Administration (FDA) in a July 13, 2011 Alerts and Notices made an about-face and said the complications are “not rare” as first reported in an advisory issued October 20, 2008.

Pelvic Organ Prolapse

When the tissues that hold pelvic organs in place become weak or stretched, pelvic organ prolapse (POP) can occur.

Symptoms: may include a feeling that the bladder, the uterus or the rectum has bulged or prolapsed into the vagina and sometimes past the vaginal opening.

Stress Urinary Incontinence

When you laugh, cough, sneeze or exercise a small amount of urine may leak. This condition might be Stress Urinary Incontinence (SUI). Women diagnosed with both or one of these problems may be treated with an implantable surgical mesh medical device, usually synthetic or in rare cases, absorbable biologic material. The mesh is permanently sewn into the pelvic area to reinforce a weakened vaginal wall or to support the urethra to treat incontinence.

From 2005 until 2010 there were approximately 4,000 reports of complications from surgical mesh reported to the FDA. Since the reporting of complications is not mandatory, that number may represent only a small portion of what is occurring in the real world.

Symptoms of Mesh Complication

In the July 13, 2011 announcement, the FDA says the following may be a symptom of a mess complication after it has been implanted through the vagina, called a transvaginal placement:

  • Mesh erosion through the vagina (this is also called exposure, extrusion or protrusion)
  • Pain
  • Infection
  • Bleeding
  • Pain during sexual intercourse, and pain to your partner’s penis when he contacts the mesh
  • Organ perforation
  • Urinary problems
  • Recurrent prolapse
  • Neuro-muscular problems with movement and pain which can result of nerve being severed
  • Vaginal scarring and shrinkage
  • Mesh contraction or shrinkage
  • Emotional problems

Many of these problems have resulted in more surgical intervention and hospitalization. In some cases, women and men have endured a dozen or more surgeries in an attempt to remove the mesh, likened to removing gum from hair and very difficult if not impossible to accomplish, according to most surgeons.

Does Not Improve Quality of Life

With all of the side effects, the FDA in a review of published scientific literature from 1996 to 2011 concluded that “transvaginal POP repair with mesh does not improve symptomatic results or quality of live over traditional non-mesh repair.”  Non-mesh repair uses stitches to tighten the pelvic floor, which requires additional surgical skills.

No single brand of mesh has been singled out for complications.

Learn More: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, July 2011, FDA Center for Devices and Radiological Health. #

 

 

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2 Comments to “FDA Warns of Symptoms of Mesh Problems”

  1. [...] and in a Public Health Notification called it “an area of continuing concern.” By July 2011, (here) there were more than 2,800 incidents of complications associated with surgical mesh. Despite that, [...]

  2. [...] Warnings and Info: – FDA Safety Communications on Surgical Mesh – Article: FDA Warns of Symptoms of Mesh Problems (July 2011) – FDA NEWS RELEASE (July 2011) – FDA SEARCH tool: MAUDE – Manufacturer and User Facility [...]

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.