While it seems as though a simple piece of mesh, used to repair hernias, as well as in transvaginal repairs, would not be a controversial medical device, in fact, surgical mesh is responsible for hundreds—possibly thousands—of adverse health issues across the United States.
Take the case of Chrissy Brajcic, a once healthy, happy mom and wife with a growing business. Following a surgical procedure to treat stress urinary incontinence, Chrissy is now bedridden, forced to constantly battle one infection after another as well as severe, chronic pain.
Stress urinary incontinence is a common female disorder among women who have gone through childbirth multiple times. Doctors commonly recommend a mesh sling, which supports the urethra, most telling their female patients the operation is simple and safe. Brajcic says she knew within hours of her surgical procedure there was a problem—“…it was like my insides were ripping out… “ Brajcic spent the next year trying to find a doctor who had the necessary skills and experience to remove the mesh implant, which, in her case, had to be extracted piece by piece.
Brajcic’s removal surgery lasted for five full hours, yet once the mesh was gone, the pain remained, and the trauma of the removal surgery caused her pelvic floor to collapse. Brajcic continues to have chronic infections, as well as pain which is so severe she is forced to be hospitalized nearly once a month. Brajcic says she is unable to even walk most days, and all the simple things she once took for granted, she is now unable to accomplish.
Chrissy Brajcic, along with thousands of other women, has filed a lawsuit against Johnson & Johnson and its subsidiary, Ethicon for the injuries she suffered from the implantation of their pelvic mesh. More than 100,000 women currently have cases against companies like J & J, Boston Scientific, AMS and CR Bard. This current mesh controversy is the latest in a saga which began more than 15 years ago. By the early 2000’s, mesh makers—who previously only manufactured mesh for hernia repair—had developed transvaginal mesh to treat stress urinary incontinence, as well as pelvic organ prolapse (when the muscles holding the pelvic organs in place become weak from childbirth or age).
FDA Safety Warning Regarding Mesh Devices
The mesh kits allowed surgeons to fix either condition, using a minimally-invasive surgical procedure, as opposed to the more traditional repair which used a woman’s abdominal tissues, and typically involved longer surgical procedures and long recovery times. Unfortunately, in 2008, after receiving adverse event reports from hundreds of women, the U.S. Food and Drug Administration issued a safety warning for transvaginal mesh used to treat stress urinary incontinence and pelvic organ prolapse.
This safety warning stated that there could be “rare” complications from the mesh, including painful intercourse, infection, erosion of surrounding tissues and chronic pain. The FDA stated in this safety warning that doctors should inform patients of the potential risks prior to surgery.
Women in the UK More “Vocal” About the Mesh Issue
In the U.K, women have been more vocal about the issue than in the U.S. Protests by women, including those in wheelchairs or forced to use a walking cane as the result of a mesh surgery, have been held in London in front of parliament on numerous occasions. Many of these women have experienced life-altering chronic pain, and are forced to exist on high dosages of medication simply to be able to get through each day. For many, their marriages have disintegrated because of the surgery, others can no longer work or take care of their children.
Kath Sansom, an advocate for women who have undergone mesh implants, launched an awareness campaign called Sling the Mesh, to warn women about the potential risks associated with the use of transvaginal mesh. Sansom herself, suffered severe pain in her legs after she underwent a mesh surgical procedure in 2015. Sansom believes her country should suspend the use of all female mesh implant devices, just like the country of Scotland id in 2014.
Is Hernia Mesh Safe?
With the spotlight on the use of transvaginal mesh, some doctors have questioned the safety of hernia mesh as well. One Canadian doctor, Dr. John Morrison, claims to have seen hernia mesh erode into nearby tissues on multiple occasions. Morrison performs mesh removals on a regular basis, receiving calls from desperate patients across Canada.
Keith Richter, 26, underwent hernia repair surgery with hernia mesh when he was only 22 years old. Since that time, Richter has had many problems with his hernia mesh implant, and now suffers such severe, chronic pain that he is unable to engage in activities he once loved—skateboarding and playing hockey. Richter has joined a class action lawsuit against Bard Canada and CR Bard, the manufacturer of his mesh implant.
Problems with Mesh
Another doctor, Dr. Vladimir Iakovley, the director of St. Michael’s Cytopathology, has examined more than 500 mesh specimens from those patients who had problems following their hernia or transvaginal mesh implant. Iakovley noted that although the mesh is implanted in a flat position in the patient’s body, it can fold, or shrink to as much as 50 percent of its original size. Iakovley likens what the mesh can do in the body to “rebar in concrete,” saying he has seen nerves, scar tissue and even blood vessels grow into the mesh, making it almost impossible, in some cases, to remove the mesh.
The mesh can also move from the repair site, puncturing surrounding tissues, such as the uterus, the bowel, the stomach and the vagina. In short, says Iakovley, mesh moves, and polypropylene mesh can degrade and become brittle inside the body over time. Like many medical devices, most of the mesh devices on the market today were fast-tracked through the FDA’s 510(k) program which only requires that the device be substantially similar to another product already on the market.
Some Doctors Believe Hernia Mesh Complications are Rare
Despite the many negative issues associated with hernia and transvaginal mesh, there remain surgeons across the nation who believe mesh is an important tool for repairing hernias as well as female pelvic disorders. In fact, urogynecologist, Dr. Colleen McDermott uses mesh regularly, claiming most of her patients are “overjoyed and thrilled,” with their mesh implant. McDermott believes the problem lies, not in the mesh itself, but in the fact that not all surgeons have the necessary skills and experience to perform these procedures. McDermott herself, received three years of specialized training in order to implant mesh, however notes that many generalists are performing mesh implants even though “you can’t learn how to do these procedures in 4 days.”
Surgeon-in-chief at Women’s College Hospital, Dr. David Urbach agrees, saying he uses mesh in virtually every hernia repair, and believes complications are rare. Both McDermott and Urbach stress that patients should be aware of the potential risks of mesh, and that patients with a high risk of complication should be offered an alternative. In 2016, Bard Canada agreed to pay $2.4 million to settle claims against their Avaulta, Align and Adjust mesh products. It remains to be seen whether J & J and Ethicon, CR Bard, Boston Scientific and AMS will settle their mesh cases or risk going to trial.
Contact Our Mississippi Hernia Mesh Lawsuit Attorneys
At Coxwell & Associates, PLLC, our attorneys believe in fighting aggressively for injured Mississippi hernia mesh patients and their families – to ensure that they receive the money they need to fully recover.
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Disclaimer: This blog is intended as general information purposes only, and is not a substitute for legal advice. Anyone with a legal problem should consult a lawyer immediately.