Johnson & Johnson’s Ethicon Transvaginal Mesh Device
Ethicon, which is a division of Johnson & Johnson, makes several transvaginal mesh devices. The transvaginal mesh devices are used to correct the condition known as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Many women have been implanted with these transvaginal mesh products, which are designed to remedy their condition. However, the transvaginal mesh devices sold and distributed by Ethicon and Johnson & Johnson has resulted in many common complaints.
There have been instances of mesh erosion where the mesh itself moves and cuts through the vaginal and pelvic tissues which causes great pain and discomfort. Surgery becomes necessary to remove the mesh in those cases. In some of those mesh defect cases, the patient’s tissue has already formed around the mesh making it even more difficult to remove it surgically. Some women have needed multiple surgeries and have still not found that they are relieved of the pain.
On June 4, 2012, Johnson & Johnson’s Ethicon division stopped selling four types of transvaginal mesh implants. In a correspondence that was sent to the U.S. District Court for the Southern District of West Virginia, Ethicon requested the FDA for approval to stop selling these devices:
Gynecare TVT Secure System Gynecare Prosima Gynecare Prolift Gynecare Prolift +M
There is overwhelming evidence that the transvaginal mesh devices generally are unsafe for use. The FDA has reported that a five-fold increase in injuries have been documented between 2008 and 2010. Even in the face of the mounting evidence, Ethicon and Johnson & Johnson claimed that the decision they made to stop selling their mesh products had to do with profits and not safety issues.
In February 2013, Johnson & Johnson and Ethicon were found liable in the first of some 4,000 Gynecare Prolift cases that are set to go to trial. In this first case, the jury found the defendants liable to a woman who had suffered from this transvaginal mesh device and was compensated for her injuries at $11.1 million, which included $7.7 in punitive damages against Johnson & Johnson.
Thousands of other cases have been filed in the U.S. District Court for the Southern District of West Virginia concerning transvaginal mesh implants. These cases are in what they call the multidistrict litigation (MDL) pool where the defendants include Johnson & Johnson, Boston Scientific, C.R. Bard, American Medical Systems and Coloplast. The alleged injuries in these lawsuits include:
- The need for multiple revision surgeries and the costs associated with them;
- Lost ability to have sexual relations;
- Loss of normal life;
- Lost wages;
- Emotional distress;
- Medical, surgical and hospital expenses;
- Pain and suffering; and
- Spousal or partner loss of consortium.
The FDA has provided a study that shows that as many as 10% of the women who undergo surgery with transvaginal mesh devices implanted in them will suffer from mesh erosion within as little as 12 months. There are many other complications that have been associated with the mesh implant which include:
- Erosion of the mesh that moves through vaginal tissue;
- Feeling a lump or something protruding from the vagina;
- Painful sexual intercourse;
- Perforation of the bladder around the vaginal wall;
- Recurring POP and SUI;
- Urinary issues;
- Vaginal bleeding; and
- Vaginal pain.
The use of transvaginal mesh devices is now known to be a risk to the health of women implanted. It has come to light that many of the transvaginal mesh manufacturers had not clinically tested their products before being sold and implanted. This means that the surgical mesh designed for POP repair may no longer be used in its current form.
If you or someone you know has been injured as a result of a failed transvaginal mesh implant or sling, please call us for an immediate free consultation.
Robert Kreisman of Kreisman Law Offices has been handling medical product defect injury cases. Kreisman Law Offices has prevailed in trials and settlements in Chicago, Illinois and surrounding communities and has successfully resolved cases for those injured in transvaginal mesh implant and sling defect devices.
With our years of experience in trying and settling medical product defect cases, Kreisman Law Offices provides the best possible services to our clients and have achieved unsurpassed results. Our service is unmatched. Please call us 24 hours a day at 312.346.0045 or toll free 800.583.8002 for a free and immediate consultation, or complete a contact form online. There is no charge for a consultation that will include an evaluation of your case, assessment of your damages such as lost income, lost wages, medical and hospital bills, past and future pain and suffering, loss of normal life and wrongful death.