Dr. Malik is a cardiologist and now an attorney in Dallas who heads his own law firm. He is board certified in internal medicine and was a practicing cardiologist for 10 years. In 2003 he decided to go to law school and has been practicing personal injury law since 2006.
MDND asked Dr. Malik his perspective on both the legal and medical questions involving synthetic mesh used for pelvic organ prolapse and incontinence.
Dr. Malik: “Women end up have TVM (transvaginal mesh) surgeries for two medical conditions. One is the prolapse of the uterus or pelvic organs and typically these are women of childbearing age and later in life. They end up with laxity of the pelvic tissue and the pelvic organs are displaced as a consequence of gravity, so you get prolapse of the uterus into the vagina. So that's number one indication. The second indication is you end up with stress urinary incontinence (SUI), again, because of the physiological changes as a result of menopause. The tissue becomes lax and as a result women start developing urinary incontinence which can occur from coughing, sneezing and straining.
“So these women have symptoms such as feeling an incomplete evacuation from bowels from a potential rectocele, or urine leaks, or the urgency to go. There are a multitude of symptoms. They go to their gynecologist who often recommends conservative therapies such as strengthening the pelvic muscles with Kegel exercises. If that does not improve, the patient may end up having some support added such as pelvic mesh placed either abdominally or transvaginally.
“They start getting side effects because it’s made of plastic and that causes erosions into the vaginal canal. It can cause perforation into the bladder and a multitude of other side effects. And ultimately unfortunately, the only treatment is to redo the surgery and remove the offending device and try and repair whatever damage has been done. You can get granulation, inflammation, bowel infections and sepsis. In other words the symptoms are real as a result of the surgery."
Dr. Malik: “I’ve been a physician for the last 30 years though I’m not a gynecologist or a urologist. I’m a cardiologist and invariably what happens is some docs don’t like to face facts and do not like to admit what they’ve done may be the cause of the subsequent side effects.
“They go to meetings and meet vendors who tell them you are not a cutting edge doctor if you are not using this space age technology. Doctors are supposed to fill out a side effect profile from procedures they do and report them to the FDA. That’s how the FDA finds out there is a problem. Unfortunately doctors don’t do that on a routine basis; they don’t want to upset the apple cart.
“The problem is multi-faceted. You've got the manufacturer of these devices who knew or should have known it would cause problem in women. They want market share and it’s an extremely competitive environment, it’s a corporate mentality. Then you have the FDA that has been lax in its oversight. They’ve created a loophole in the regulation. Unlike premarket approval (PMA which requires clinical trials and studies), the FDA has created a fast-track process, the 510(k) process and all the manufacturers have to do to avoid the PMA is to go through this fast-track process and demonstrate that your medical device is comparable to others on the market. As long as you can demonstrate that then you can get it to market in a shorter time. All of these mesh companies took advantage of that loophole and dumped on the public these defective devices and we have the fiasco we have here."
Dr. Malik: “We try and determine if the injury is the result of bad medicine or a bad surgical technique versus pure product liability versus a combination of both by creating a time line. If someone develops an infection a day or two after surgery, that is more likely due to surgery than the device. If there is an ongoing prolapse within a week of surgery, then it is likely due to surgical technique. If a year or two year outside of surgery and suddenly they have erosion into the vaginal canal and into the rectum that is more likely due to the mesh.
“The short answer is we don’t know what component is medical malpractice by physicians versus what is due to a purely defective product out there. There are complications after any surgery. Infection is common.
“In other words this is a complicated area of litigation. There are at least 20 mesh manufacturers in the U.S. Some women have multiple devices from different manufacturers. Further complicating this is the fact that six manufacturers are hauled into open court in West Virginia to sort it all out. The various manufacturers can point the finger at each other.
“The take home message - it’s a commonly used gynecological procedure in the U.S. We expect it’s the tip of the iceberg. Since many women have these surgeries we expect litigation to grow as these devices break down. I would tell the women, look, you are not alone, this is a problem mass tort attorneys are trying to address but in my humble opinion it will be three to five, maybe seven years to work its way through the courts. Get the necessary treatment. If you are unsatisfied seek a second opinion."
“I personally believe yes, it’s a defective product. Mesh and bladder slings both. There is no benefit to the patient to have it put in. It only increases side effects down the line. Why put mesh in with no benefit? Eventually it will break down and when it does break down because it is made of polypropylene, it will erode into internal organs."
“No, any time you put a foreign body into the abdominal cavity it will react with the local tissue.
“I think at the end of the day the story is not written yes on the widespread use of mesh and the litigation. We are getting, I kid you not, one to two calls a day on vaginal mesh and we have several hundred potential clients we are evaluating and getting ready to file and we are not alone. Many other attorneys are in a similar situation. It’s going to be big – there is no way of knowing!"
The nine-day trial of Tina Burris v Johnson & Johnson ended with a defendant win after jurors decided the company had issued adequate warnings about the risks of Prolift.
Kila Baldwin, who has won in excess of $150 million for transvaginal mesh injured women, has broken from Philadelphia-based Kline Specter to form a new personal injury law firm.
Tina Burris, implanted with two transvaginal meshes made by Johnson & Johnson (Ethicon) will have her defective product day in a Toledo, Ohio courtroom beginning in July.