FDA Warns of Symptoms of Mesh Problems

Aug 10th, 2011 | By | Category: FDA News, 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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5 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 […]

  3. bill says:

    I was implanted with the surgical prefix mesh and plug on Jan.29,2014. My surgeon told me before the surgery when I asked her if it was anything like the vaginal mesh that was being used on women that it was a new and improved mesh she was going to use on me. I specifically told her I did not want the mesh to be implanted in me if it was anything like the mesh that was used on women due to all the recalls and complications. She assured me it was not and it was new and improved and other patients she used the prefix mesh and plug on had no complications. Well after I had the surgery and I woke up from the anesthesia I was in chronic pain and knew right away something was wrong. They told me it was normal and sent me home. For a couple weeks I suffered with chronic pain, swelling, stomach bloated making me look like I was 9 months pregnant,trouble with bowel movements, etc. I told my surgeon at my next Dr appt. About my complications, she tells me it is normal but could not explain my bloating. Each and every follow up visit thereafter was the same. I had to beg for pain medication which she barely gave me that only took the edge off. Finally after 5 months of suffering she said I had 3 options 1)go to pain specialist. 2) get second opinion. 3) have another surgery and remove mesh and plug. Well, I went with the first choice but nothing the pain specialist did for me worked, like sample creams, lyrics, and many shots in my groin for nerve block, nothing worked after several visits. So I finally found another surgeon and within the first 5 minutes of speaking with him he told me he could not believe my first surgeon would implant me with the prefix plug and mesh. That he used that same mesh 15-20 years ago and all his patients he used it on all had serious complications and that that type of mesh used on me was junk. So much for new and improved hu?????? I had my second surgery done on june6,2014 to have the mesh and plug removed. Still in recovery as of today. As for my first surgery I could not hardly get out of bed, have to either lay on the couch or in bed. Still having the same complications I now as I did with my first surgery. This mesh needs to be recalled before it destroys any more lives. There has been no enjoyment of life for me, I can’t have sex, walk my beagle puppy. I can’t work and I am on short term disability thru my employer, which is about to expire in a couple weeks and I am far from recovering .PLEASE HELP GET THIS PERFIX MESH AND PLUG FOR INGUINAL HERNIA REPAIR RECALLED BEFORE IT DESTROYS THOUSANDS OF MORE LIVES OR EVEN CAUSE DEATH!!!!!

    • Jane Akre says:

      Bill- I am so sorry….. If a doctor tells you this is “new” and “improved” or “different” mesh- ONE QUESTION TO ASK!! Is it made of Polypropylene, also noted as PP? If the answer is “Yes” it is the SAME mesh not different. As a patient and consumer you deserve to know the truth… and unfortunately you were not told the truth. I’m so sorry that a doctor does that. Where is the profession these days? Please give Bruce Rosenberg a call at 954-701-5094- he is hernia mesh injured and knows the latest on doctors, lawyers, treatments etc. he does this voluntarily- has no connection to any. He has the nonprofit Meshoma Foundation… brosenberg1@bellsouth.net. He is a great resource for all hernia mesh injuries and may have some direction for you. Shame on that doctor!! In fact, we need a Hall of Shame of doctors who continue to lie to patients. Please contact him… and thanks for writing. Let us know what happens. ~ Best, Ja

  4. ct says:

    Hi. My mom HD surgery where hey users a mesh for repair of a hernia. Since the surgery, she has suffered debilitating pain and symptoms. Many of which we’ve compared to the symptoms found on this website.we are requesting information on Drs. Who are aware of this problem people who have had hernia surgery using a mesh that can help her with some information. I you can help, please send me a message at: shubie42@gmail.com. we will appreciate any information we can get about what can be done. Thank you very much.

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