Surgical Mesh Patients Angry at Manufacturers' Failure to Warn
UPDATED: June 19, 2018
It’s all about you. We want to help you make the right legal decisions.
We strive to help you make confident law decisions. Finding trusted and reliable legal advice should be easy. This doesn't influence our content. Our opinions are our own.
Surgical mesh patients who were surgically implanted with transvaginal mesh are angry that they weren't warned about risks - and are taking their cases to court. Many of these patients, along with numerous medical experts, say that they would have been better off having traditional surgery - an issue the FDA plans to address in September of 2011.
Surgical Mesh Side Effects: A Mounting Controversy
When a woman has pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI), there are two basic ways to repair them. One is to do a primary repair, which is a surgical option without the use of the mesh. The other uses vaginal mesh.
The problem is that a lot of patients have been having surgical mesh side effects, which is becoming a mounting controversy. Side effects include erosion through the vaginal tissue, pain, infection, bleeding, pain during intercourse, organ perforation from surgical tools used in the placement procedure and urinary problems. Many may need additional surgeries or hospitalization to treat complications or remove the mesh. However, mesh removal may not be a viable option.
In fact, the U.S. Food & Drug Administration (FDA) issued a public health notification on July 13, 2011 discussing treatment of these serious complications. William Maisel, MD, MPH, deputy director of FDA's center for devices and radiological health said that the FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant - complete removal may not be possible and may not result in complete resolution of complications. The most frequent complications include mesh erosion into the vaginal bladder, into the intestines and uterus, mesh shrinkage or migration, scar tissue formation and all of the side effects that may result.
The continued use of transvaginal mesh in general also continues to be controversial as many medical experts say that traditional surgical procedures to treat POP and SUI may be better - and safer - than mesh surgery. The FDA has taken note and will convene an expert panel to discuss surgical mesh injuries in September of 2011. However, many surgical mesh injury attorneys believe that the discussion may result in a recall of the products in the long run.
Injured Surgical Mesh Patients Angry
Patients who have undergone surgery to correct POP or SUI using transvaginal mesh procedures are understandably angry that they weren't warned about these dangers. One blogger wrote: "How often have we seen medical devices/products released to the public that have eventually caused more serious complications than what they were trying to help? The rush to market seems to be predicated on how much money can we get before the public is harmed. Perhaps the testing needs to be longer before going to market or perhaps [it's better to] just hit the manufacturers where it hurts by filing a lawsuit to face the financial claims."
It seems to be latter that patients are choosing as surgical mesh lawsuits are being filed in record numbers against manufacturers alleging that more testing should have been done, warnings should have been issued and that the products should have been recalled long ago.
Mesh Injury Lawsuits Allege Product Defect & Medical Malpractice
While many of the lawsuits already filed allege that the products are defective, some have been filed as medical malpractice cases alleging that physicians failed to provide a proper informed consent to patients and should have known about studies that warn about the dangers of using transvaginal mesh.
Transvaginal mesh products are manufactured by several companies such as Johnson & Johnson, CR Bard, Boston Scientific, American Medical System and others. If you've been injured due to surgical mesh, contact a surgical mesh injury lawyer to discuss your rights and find out whether you might be entitled to compensation.