After several months of review, the agency issued a public health notice about meshes used to treat pelvic organ prolapse and stress urinary incontinence due to a host of serious complications. At the same time, the FDA also updated new info for hernia patients.
For POP and SUI patients, the FDA received 1,106 reports between 2005 and 2008 from nine surgical mesh makers of complications, which are usually placed transvaginally using tools for minimally invasive placement. The most frequent problems included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion (look here).
For hernia patients, the FDA received 1,911 adverse events between 2004 and 2008, although the vast majority were related to two meshes that have already been recalled. In any event, the complications include adverse reactions to the mesh, adhesions (when intestinal loops adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels. Other problems can occur with or without the mesh, including infection, chronic pain and hernia recurrence.
"This has been a long time coming, but it is really just one step in the process. It is one thing to warn the general public, but the surgeons that implant these meshes need to understand that they could be doing great harm to someone. So, yes it is suffcient for now, until the investigation is over," says Jim Shull, a New Jersey resident who had a bad experience with a mesh and has lobbied FDA officials to take tougher steps. "But these products need to be made safer and if that can not be accomplished then they should be pulled from the market.
UPDATE: This is the list of manufacturers: American Medical Systems; Boston Scientific; CR Bard; Coloplast Manufacturing; Ethicon; Mentor; Sofradim; Tyco Healthcare; Proxy Biomedical, and Synovis Surgical Innovations. An FDA spokeswoman notes that eports have not been linked to a single brand or model of mesh and "that we believe this is a problem across the industry with all brands and manufacturers." Industrywide, there are about 20 manufacturers.
13 Comments
Hi Ed, Do you know which manufacturers are included in the FDA's public health notice and updated information notice?
Hi Just Wondering,
No, I don't know, but I've asked the FDA for that info and will update if I receive that later or tomorrow or whenever.
Ed
Ed, Thanks for the excellent reporting and follow through, this is truly an informative website. The issue now will be whether the FDA does in fact release a Public Safety Notice on Hernia Mesh specifically (not just a link) and state the materials degredation/erosion injury issue, in addition to the explantation injury. Unfortunately practically no one visits the FDA Public health Notice site until after they are already injured. The FDA needs to release the notices via mass media to inform the publicas these are extremely common surgeries. Please contact me as I have more info for you, Thanks again, Bruce
Ed,
Just wondering, can you tell us who this Jim Shull is and what makes him an expert? I doubt he had mesh implanted for SUI or POP! Hernia mesh from what I have read is a whole different subject matter. (Google: Kugel Mesh lawsuit) and the obtape was pulled from the market due to it's small pores.
Thanks!
Julie
Hi Just Wondering,
I didn't hold out Jim Shull as an expert. I identified him as someone who had a bad experience - with a hernia mesh, yes. He had alerted me to the upcoming FDA announcement by virtue of his interactions with them about the overall mesh safety issue.
Hope that helps, ed
Julie
As Ed stated, I am not an expert, but one who has experienced very harmful effects from surgical mesh. During the course of my research I met some wonderful woman and men who have suffered. I have spent hundreds of hours on the phone and emailing many members of the FDA/CDRH from the commisioner on down. I do believe that these releases are a positive step in the right direction, with more to come. Ed, Thank you again for following thru, it is deeply appreciated. Jim
Ed,
In 2005 had two meshes put in because of hernias. Soon after the procedure I had experienced tuging pain in the hernia areas, bladder pain and frequent urinary problems. lower intestinal pain and occasional sharp pains that come and go. I had this for about a year until a doctor suspected a chronic infection and gave me antibiotics for 45 days. This cleared up most of the pain problems. However I still have some of the other issues that I didn't have before the procedure. I need to investigate this further... will the doctor that performed the procedure know what kind of mesh was used? should I have them replaced? Should I get a lawyer?
Hi Andrew,
Well, I would imagine the doctor who performed the procedure would have records to consult showing which device was used. Then again, I am only guessing. But the question is worth asking. As to a lawyer, I have to give you my standard response, which is that I do not encourage or discourage litigation. That is an individual choice. As a journalist, I'm always happy to discuss most anything, but I must refrain from offering advice.
Hope that helps, ed
Andrew, I have sympathy for your situation. But as to whether you should consult a lawyer - it depends if you want to sort out your medical problems or get compensated for them.
Aside from Andrew's specific situation the whole litigation issue is just one aspect of a bigger problem isn't it? Healthcare costs are apparently out of control, physicians are apparently struggling to stay in practice, pharma companies are profiteering at patients' expense, and now insurance companies are buying steak dinners to encourage prescribibg of generics not brand names. But for as long as the medical malpractice lawyers are in business and the 'wronged' can get compensated for their troubles, we'll struggle to deal with one of the bigger problems - and cost drivers - of healthcare expenses.
Andrew If your doctor is not forthcoming, you can go to the site of where the surgery was performed. You can request all of your surgical records generated on your case. In it you will find the type of mesh used in your surgery, along with lot# and serial#. You must do extensive reasearch, to find other types of complications associated with these products. There are very many complications associated with all of the hernia meshes, the FDA is still investigating these products. Andrew, you are not alone, there are thousands of us that are having serious complications from mesh surgeries. Male and female alike.
Just a question about the mesh for use in pelvic surgery. I know Julie mentioned the obtape being removed from the market, but do they go into at all the type of mesh that they are looking into? Polypropolyne, gore-tex, macro or micro-porous??? There are so many factor that go into how the mesh will work or not work once implanted. The Medical industries has been using mesh for slings for over 9 years now with amazing cure rates and a less that 2% erosion rate. Macro-porous polypropolene mesh.
Hello...I just came across this site in researching medical mesh. I had the AMS Sparc TVT put in in June 2007. I immediately started having problems. Now the mesh has eroded through my vaginal wall. My Gynecologist snipped out three pieces and showed them to me, gave me Estrace cream to apply and return to her in 6 weeks. I filed my complaint with the F.D.A. in March 2009. Do you have any updates? Thanks in advance....Laura
Laura,
I have done extensive research on several types of bladder mesh, and have tied them all either directly or indirectly to a product that was recalled by its own manufacturer in a letter to the FDA on January 22, 1999.
If you need more information, or assistance researching the AMS Sparc TVT, please contact me at aunt_sanner@yahoo.com
I have also authored a petition on the CARE2 Petition Site entitled: "Demand Justice for Surgical Mesh Victims." Everyone please, go to the site and sign the petition, then encourage your family and friends to do the same. I am desperately trying to secure a Congressional Hearing for myself and a few other mesh victims to serve as spokespersons to address the issues of surgical mesh and the FDA's 510K approval process for a permanently implanted device.
If ever I succeed in getting a hearing, I hope that Bruce Rosenberg and Jim Shull, who posted above will be two of the people to help me address this. They are both quite knowledgeable about surgical mesh!