SURGICAL MESH COMPLICATIONS | INJURED BY SURGICAL MESH, CONTACT US!
FOR IMMEDIATE RELEASE Truth in Medicine Incorporated July 27, 2011 Lana Keeton (305) 671-9332 ext#1 lanakeeton@truthinmedicine.us.com
TRUTH IN MEDICINE PRAISES FDA FOR MESH WARNING, CALLS FOR END TO SYNTHETIC MESH USE
Following years of persistent communication from the patient advocacy group, Truth in Medicine, the federal agency that oversees medical devices issued its second strongly worded warning about the dangers of surgical mesh. Truth in Medicine feels there is still more important work ahead in removing mesh from the market except in rare cases. Truth in Medicine is also calling for doctors and professional associations to recommend to their members to avoid the use of synthetic mesh whenever possible, whether for hernia repair, pelvic organ prolapse or bladder suspension.
The Food and Drug Administration (FDA) in its July 13 advisory admits that petroleum-based meshes, which are the medical devices implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), causes at least 10% more complications than previously thought and is exposing patients to unnecessary risks such as pain, bleeding and infection.
“The added benefit of using the mesh is not evident, but there certainly appears to be an added risk,’’ said Dr. William Maisel, Food and Drug Administration’s (FDA) chief scientist and deputy director of the center for devices. Lana Keeton had a surgically implanted mesh which failed and led to years of devastating pain and repeated removal surgeries.As a steel broker she understood the physical and chemical properties of steel, translated it to synthetic surgical mesh, and combined it with her ability to research to become a patient advocate founding Truth in Medicine in 2008. With thousands of contacts from injured patients worldwide, the group has been persistent in its calls to the FDA, through face-to-face meetings, and in testimony at public hearings, a driving force that led the FDA to issue this second public warning.
“We’ve been talking to them since ‘07 and we’re not going away. Our public pressure has been instrumental in raising the awareness of enormity of the problem,” said Keeton. “Ultimately there is no added value to synthetic surgical mesh and a huge downside” said Keeton who would like the FDA to recall the medical device from the market. Keeton recommends doctors follow the lead of Dr. Shlomo Raz, world renowned UCLA pelvic floor repair specialist and Professor of Urology who presented his non-mesh procedure for suture only pelvic organ prolapse repair at the American Urological Association (AUA) in May of this year.
The FDA reported that between 2008 and 2010 there were 1,500 adverse event reports of mesh complications, a number that increased 50% from the prior three years. More than 75,000 women had mesh implanted for pelvic organ prolapse last year and approximately 200,000 had mesh surgery for incontinence, though the warning issued July 13 only addresses mesh implanted for POP surgeries.
Most women experience pain and bleeding within a year after their surgery. Patients often must undergo multiple surgeries to remove the mesh which Keeton says is like cutting gum out of your hair. “Any complication is devastating,” says Keeton who knows from personal experience having endured 17 procedures/surgeries to remove the mesh placed in her in 2001. Dr. Maisel, the FDA scientist, said the traditional surgery performed by a skilled, experienced surgeon using stitches only may be a better alternative for women suffering from POP and SUI. Manufactured by at least nine different companies, “plastic” mesh is used to reinforce the pelvic organs in a patient suffering from incontinence and/or prolapsed organs. Surgeons typically insert the mesh through the vagina, though some surgeons prefer placement through an incision in the abdomen. The agency is reviewing the use of mesh for incontinence and will hold a two-day meeting in September to determine if there is any benefit to synthetic surgical mesh and whether it should be reclassified from a low to a high-risk device. Synthetic surgical mesh is considered to be low-risk. “Something that is implanted in your body permanently can never be considered low-risk” says Keeton who also points out that the agency is currently reassessing the controversial 510 (k) clearance process that allows untested, unsafe medical devices on the market. A manufacturer only need claim that a similar “predicate” device is already on the market to obtain clearance for a new medical device. In the case of surgical mesh, the predicate device for all current bladder suspension meshes was taken off the market after it was found to be “adulterated and misbranded” and led to problems such as vaginal erosion or dehiscence and did not appear to function as intended. The FDA does not require the agency to re-review the medical mesh currently on the market that used the recalled mesh as a predicate device.
The 510 (k) fast-track system has gone largely unchanged since the 1970s.#
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