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LOOKING FOR PATIENT CARE PROVIDERS TO ASSESS PATIENTS WITH TVM IMPLANTS
THE CONCERN...
Many female patients across the country received Transvaginal Mesh (“TVM”) implants for various problems, including Pelvic Organ Prolapse (“POP”) and Stress Urinary Incontinence (“SUI”). Recently, it has come to light that many of these patients are suffering from adverse effects from the TVM. The FDA concluded that “serious Patients are complications associated with suffering from surgical mesh for transvaginal vaginal and mesh repair” are not rare. erosion, internal -FDA July 2011 bleeding, fistulas, infections, mesh shrinkage and migration, organ perforation and punctures, pain with intercourse, general discomfort, recurrent prolapses, vaginal wall narrowing, vaginal scarring and shrinkage, neuromuscular problems and emotional trauma.
“The FDA believes the overall increase in the number of serious adverse events [related to TVMimplants] is cause for concern.” -FDA July 2011
“Most surgeons would probably not have used a completely new product if there was no oversight.” -Professor Andrew Sokol, Georgetown University School of Medicine.
“These products are associated These women genuinely with serious adverse events... need help. Women who compounding the concerns received these implants may regarding adverse events are be symptomatic or asympthe performance data that fail tomatic. Any female who to demonstrate improved received a TMV implant clinical benefit over traditional needs to be evaluated non-mesh repair.” immediately by a well-FDA July 2011 trained physician, hopefully a primary care provider that can assess and determine the extent of any problems that may or may not exist. “15.6% of surgical mesh patients develop erosions.” -American College of Obstetricians and Gynecologists
THE NEED...
Doctors must rely on the information available to them in treating their patients. Often times, doctors rely on reputable manufacturers as it relates to medical devices. In this instance, it is possible that doctors were deceived as much as patients. A deceived doctor is not to blame for a manufacturer’s deception. However, a TVM patient’s doctor is in a unique position to correct this wide-spread problem, one patient at a time. Doctors can re-evaluate patients with TVM implants, assess any existing problems, and take the necessary action to correct any problems that may exist. If the doctor finds nothing
THE DOCTORS...
THE MANUFACTURERS...
Manufacturers, such as Johnson & Johnson, C.R. Bard, American Medical Systems, and Boston Scientific, marketed TVM implants to doctors without sufficient clinical
Johnson & Johnson stops selling controversial vaginal implants, calling it a “global discontinuation.” -Reuters July 2012
wrong with a TVM patient, he or she can and will provide something invaluable; soundness of mind for a patient in distress. Essentially, an informed doctor’s care may very well be the solution to many of these women’s problems.
“The FDA has not seen conclusive evidence that using transvaginally placed mesh…improves clinical outcomes…and it may expose patients to greater risks.” -FDA July 2011.
trials and, in some cases, even without FDA approval. The medical evidence and scientific literature now illustrates quite clearly that TVM implant surgery in many cases is no better than more traditional treatments, and can also cause many adverse side “Johnson & Johnson sold a vaginal effects that require mesh implant for three years additional treatment, before U.S. regulators approved the device.” as well as additional -Bloomberg corrective surgeries. Manufacturers essentially rushed these products to the market without proper protocols, testing, clinical trials, and/or approval. By putting profits before safety, manufacturers deceived doctors and put many female patients at serious risk of harm.
“...higher rates of surgical complications and post-operative adverse events...higher scores of stress incontinence and higher frequency of new stress incontinence...higher rates of sexual pain...” -New England Journal of Medicine
Transvaginal Mesh Safety Awareness Group is looking to doctors to join our fight. We need doctors who have treated patients who received TVM implants to identify those patients, educate them, and recommend additional treatment if necessary—we are looking for patient care providers, not litigation experts or legal advocates. We are willing to assist doctors in this process by paying generous physician consultation fees and covering medical charges for any care rendered to correct or repair damage from a TVM implantation. This is our commitment. We are asking doctors for their commitment.
THE GOAL...
The TVM Safety Awarness Group
THE CONCERN...
Many female patients across the country received Transvaginal Mesh (“TVM”) implants for various problems, including Pelvic Organ Prolapse (“POP”) and Stress Urinary Incontinence (“SUI”). Recently, it has come to light that many of these patients are suffering from adverse effects from the TVM. The FDA concluded that “serious Patients are complications associated with suffering from surgical mesh for transvaginal vaginal and mesh repair” are not rare. erosion, internal -FDA July 2011 bleeding, fistulas, infections, mesh shrinkage and migration, organ perforation and punctures, pain with intercourse, general discomfort, recurrent prolapses, vaginal wall narrowing, vaginal scarring and shrinkage, neuromuscular problems and emotional trauma.
“The FDA believes the overall increase in the number of serious adverse events [related to TVMimplants] is cause for concern.” -FDA July 2011
“Most surgeons would probably not have used a completely new product if there was no oversight.” -Professor Andrew Sokol, Georgetown University School of Medicine.
“These products are associated These women genuinely with serious adverse events... need help. Women who compounding the concerns received these implants may regarding adverse events are be symptomatic or asympthe performance data that fail tomatic. Any female who to demonstrate improved received a TMV implant clinical benefit over traditional needs to be evaluated non-mesh repair.” immediately by a well-FDA July 2011 trained physician, hopefully a primary care provider that can assess and determine the extent of any problems that may or may not exist. “15.6% of surgical mesh patients develop erosions.” -American College of Obstetricians and Gynecologists
THE NEED...
Doctors must rely on the information available to them in treating their patients. Often times, doctors rely on reputable manufacturers as it relates to medical devices. In this instance, it is possible that doctors were deceived as much as patients. A deceived doctor is not to blame for a manufacturer’s deception. However, a TVM patient’s doctor is in a unique position to correct this wide-spread problem, one patient at a time. Doctors can re-evaluate patients with TVM implants, assess any existing problems, and take the necessary action to correct any problems that may exist. If the doctor finds nothing
THE DOCTORS...
THE MANUFACTURERS...
Manufacturers, such as Johnson & Johnson, C.R. Bard, American Medical Systems, and Boston Scientific, marketed TVM implants to doctors without sufficient clinical
Johnson & Johnson stops selling controversial vaginal implants, calling it a “global discontinuation.” -Reuters July 2012
wrong with a TVM patient, he or she can and will provide something invaluable; soundness of mind for a patient in distress. Essentially, an informed doctor’s care may very well be the solution to many of these women’s problems.
“The FDA has not seen conclusive evidence that using transvaginally placed mesh…improves clinical outcomes…and it may expose patients to greater risks.” -FDA July 2011.
trials and, in some cases, even without FDA approval. The medical evidence and scientific literature now illustrates quite clearly that TVM implant surgery in many cases is no better than more traditional treatments, and can also cause many adverse side “Johnson & Johnson sold a vaginal effects that require mesh implant for three years additional treatment, before U.S. regulators approved the device.” as well as additional -Bloomberg corrective surgeries. Manufacturers essentially rushed these products to the market without proper protocols, testing, clinical trials, and/or approval. By putting profits before safety, manufacturers deceived doctors and put many female patients at serious risk of harm.
“...higher rates of surgical complications and post-operative adverse events...higher scores of stress incontinence and higher frequency of new stress incontinence...higher rates of sexual pain...” -New England Journal of Medicine
Transvaginal Mesh Safety Awareness Group is looking to doctors to join our fight. We need doctors who have treated patients who received TVM implants to identify those patients, educate them, and recommend additional treatment if necessary—we are looking for patient care providers, not litigation experts or legal advocates. We are willing to assist doctors in this process by paying generous physician consultation fees and covering medical charges for any care rendered to correct or repair damage from a TVM implantation. This is our commitment. We are asking doctors for their commitment.
THE GOAL...
The TVM Safety Awarness Group
