Chaffin Luhana LLP, a national plaintiffs-only law firm, alerts women that Ethicon, a division of Johnson & Johnson, has announced a voluntary withdrawal of its Gynecare mesh products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The products include the GYNECARE TVT SECUR system, GYNECARE PROSIMA Pelvic Floor Repair System, GYNECARE PROLIFT Pelvic Floor Repair System, and GYNECARE PROLIFT+M Pelvic Floor Repair System. Ethicon also has announced that it plans to update its labeling for GYNECARE GYNEMESH® PS to limit its use to abdominal procedures for the treatment of POP.
BACKGROUND
Surgical mesh is a medical device used to repair pelvic organ prolapse and stress urinary incontinence resulting from weakened, stretched, or damaged tissues.
Pelvic organ prolapse occurs when pelvic muscles and tissues can no longer support the pelvic organs. According to the U.S. Food and Drug Administration (FDA) Safety Communication of July 13, 2011, thirty to fifty percent (30 – 50 %) of women experience POP during their lifetime. For some women with POP, mesh is surgically implanted vaginally to support and uphold the pelvic organs.
Stress urinary incontinence is a condition when urine leakage occurs as a result of physical activity, such as exercising, coughing, sneezing, or laughing. For some women with SUI, mesh is vaginally implanted to support the urethra.
PAST FDA COMMUNICATIONS
On October 20, 2008, the FDA issued a Public Health Notification stating that although rare, serious complications were associated with transvaginal mesh products used to treat SUI and POP. After subsequent research and analysis, the FDA issued an updated Safety Communication on July 13, 2011 stating that serious complications resulting from repair of POP are not rare after all.
The FDA stated that surgical mesh may not be more effective than traditional treatments, and healthcare providers should “recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.” The FDA requested that healthcare providers choose mesh surgery only after considering the risks and benefits of non-mesh procedures.
Symptoms resulting from vaginal mesh implants include: abdominal and pelvic pain, urinary problems (i.e. leakage, urgency, and frequency), painful sexual intercourse (dyspareunia), vaginal scarring, and erosion of mesh, which is the most commonly reported problem. Doctors may recommend removal of the mesh as a relief from these symptoms; however, removal of the mesh often requires multiple surgeries with added health risks. In many instances, complete removal of the mesh is not possible because of mesh erosion.
ETHICON MESH WITHDRAWAL
On June 4, 2012, Ethicon, a Johnson & Johnson subsidiary and a global medical device company manufacturing various mesh products, voluntarily withdrew the following products from the market: GYNECARE TVT SECUR system, GYNECARE PROSIMA Pelvic Floor Repair System, GYNECARE PROLIFT Pelvic Floor Repair System, and GYNECARE PROLIFT+M Pelvic Floor Repair System.
Pending FDA approval, Ethicon has requested 120 days to stop marketing these products. This time period will allow Ethicon to notify consumers, allowing surgeons and hospitals to find alternative methods of treatment. Ethicon also requested that the FDA’s Office of Surveillance and Biometrics place the existing 522 orders requiring additional studies on hold.
Additionally, Ethicon plans to continue to market and sell its GYNECARE GYNEMESH® PS with updated labeling for Indication for Use: restricting use to abdominal sacrocolpopexy procedures for treating POP.
The FDA has not yet responded to Ethicon’s proposals.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.
4 Comments
Noreen Wideman
As a victim of TVT Secur complications in contact with many other women with similar mesh injuries I'm wondering if this is just a token four products to be sacrificed from the profit producing medical device lines to appease public opinion. There are other Gynecare Ethicon meshes that have caused grievous harm that are not included with the four named products. As far as I've been able to research they are made of the same non-inert synthetic polypropylene that causes life altering allergic reactions caused by the composition of the mesh , not the style of mesh, or doctor error in placements of the mesh. The is not inert ! It shrinks, breaks apart, migrates and entraps nerves! That is not the fault of doctors but of the manufacturers. Manufacturers have been caught with their pants down marketing meshes not adequately tested for human safety. Paying for extensive testing may in the long run may have been be more cost effective than having to compensate women who as it turns out were the test lab rats for many medical meshes. I'm an angry, crippled by mesh woman who did not volunteer to be a test patient.
Diane Fichter
I am the lucky recipient of the Gynecare Johnson & Johnson TVT-O whose quality of life has been drastically changed since the implant of said device. I hope that J&J steps up to the plate and pulls all the other mesh slings produced by them!
Mine is not in the recall but let me tell you, my injuries and health issues are without a doubt as easily as devastating as those who have the named recalled slings. I am outraged that J&J has not made any announcement of pulling ALL SLINGS! I can only hope and pray that you do the right thing by us women and hear our cries and hear our voices and know that we will NOT GO AWAY!!!! We will stand united and raise our voices louder and louder until you hear our cries and do right by us!
Jemima Williams
In 2002 I had an Ethicon Mersilene Mesh implanted as a surgical mesh sling, after a pelvic organ prolapse. My life has been devastated and also that of my family. I am one of the 'lucky ones' because most of the mesh has now been removed after several operations and humiliating personal tests. A piece of the mesh has grown into the sacral fold and cannot be removed because it is too close to an artery. An operation in 2005 had to be abandoned because I had a very bad haemorrhage and had to have a ten pint blood transfusion. It has been a very hard ten years. In March of this year I had another mesh removal operation and I have been making a slow recovery from this.
I feel most strongly that ALL Surgical Mesh Implants should be removed from the GLOBAL MARKET until further clinical trials have been done.
I also feel that Johnson and Johnson have a duty of care towards patients suffering with the complication of Surgical Mesh Implants. They should, at the very least, make certain that ALL of the patients injured by Surgical Mesh Implants are cared for medically, so that they can re-build their devastated lives.
Jemima Williams
Lucille Jones
Another victim of this horrible mesh mess has left me a broken person looking for help to find a surgeon who is qualified and skilled to remove this GYNECARE TVT that i have had in since 2002. It has caused me emotional distress,suffering, loss of enjoyment in life,financial loss and physical endless pain. Wining and dining proffesionals and not to mention perks to sell this product has been at the exspense of lives,lives that will never be the same.As days turn into wks and wks turn into months there are women out here who are suffering because of an all mighty dollar that was made by JOHNSON AND JOHNSON. Yes there are a whole line of these devices that were made and being biochemically made should not have been put in women to be tested on. More clinical testing and research should have been done. A study of up to 10 years was supposedly done.... then what happens after that? Somebody has to be accountable for what has happened to these women who will never be the same before this mesh mess.Our lives have been altered forever and thats thanks to someone not doing their homework!
Comments for this article are closed.