Tens of thousands of women around the world have had a product called surgical mesh implanted in their bodies as a response to several serious medical issues. What they did not know, and are only just beginning to learn, is that the mesh may in the end cause far more damage than the original symptom for which it was placed.
According to the FDA, ” Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In uro-gynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.”
In 2008, the FDA issued a letter to surgeons using surgical mesh, also known as trans-vaginal mesh, to seriously consider using alternative approaches to the problems the mesh had been employed as a response to. These problems included :
The products were manufactured and supplied by these firms:
Johnson & Johnson®
American Medical Systems®
They have been marketed under a number of names and several configurations.
The FDA letter stated, in part:
“October 20, 2008
Dear Healthcare Practitioner:
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications 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. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.”
This was in 2008. Since that time, the number of complications, as well as the rationale for using the mesh itself (along with the number of medical problems the mesh has been used for) has increased significantly. Far more than the 1000 women cited in the FDA letter have surfaced with severe, sometimes life-threatening complications. Many have had numerous surgeries to try and remove the mesh, or respond to the damage to organs and tissues caused by the mesh, or both.
In July, 2011, the FDA issued an update, that in part reads:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.(italics added)
From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.”
A link to the full Update is here. ( https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm)
In 2010 alone, there were at least 100,000 pelvic organ prolapse repairs with surgical mesh. About 75,000 of these were transvaginal procedures, according to the FDA. And unlike many implanted medical devices, mesh cannot be easily removed, making the issuance of an FDA-ordered recall nearly impossible to carry out. To make the situation even more troubling, evidence shows the various manufacturers had knowledge about the risks at least as far back as 2006, yet did nothing to stop selling these products, showing that profits mattered far more than the risks of damaging the health of tens of thousands of woman.
The Cartwright Law Firm has been receiving many calls about this serious issue, and is working with other firms to represent women who have been seriously affected by the implantation of trans-vaginal mesh, no matter which manufacturer or what variation of the product was employed. To date, thousands of cases have been filed against the various manufacturers of the mesh products.
The first case related to this issue to go to trial recently was awarded $5 million dollars by a jury in Bakersfield, California. The woman in that case has had to undergo eight surgeries to date to try and repair the damage caused by the mesh. She still cannot be certain how many more surgeries she will require in response to the damages she has suffered, and neither are her doctors. A news article and a video news report about that case can be seen here:
The problems with the mesh products appears to be two-fold: biomechanical – the mesh interferes with the normal workings of the tissues and organs in the areas where the mesh is implanted; and bio-chemically – the polypropylene materials used to make the mesh products has been associated with damage to neurotransmitters: researchers have found in laboratory experiments that oleamide, which interacts with neurotransmitters, may leak out of polypropylene plastics. While more research needs to be completed to further explain the connection between this leakage and some of the damages being seen from trans-vaginal mesh implantation, continuing to use humans as guinea pigs for the medical device manufacturers must be stopped.
Patients who have had an implantation of trans-vaginal mesh, even if they have yet to experience painful medical complications, should contact The Cartwright Law Firm immediately to protect their legal rights. The Cartwright Law Firm has represented many victims of defective medical products for more than 30 years, with outstanding results. We urge you to call us today at 415-433-0444 for a free consultation, before you have to undergo any further procedures or suffering.