Transvaginal mesh products like Gynecare mesh have been linked to serious complications, such as infections, recurring organ prolapse, and damage to the bowels and bladder. If you suffered these or other complications after being implanted with a Gynecare mesh product, a Cincinnati Gynecare mesh lawyer could help you recover compensation for medical costs, lost wages and other effects of your injuries. Our firm's dedicated defective medical device attorneys can discuss your situation in a free, no obligation legal consultation. If you have a case, we can help you with every aspect of the legal process. We take defective medical device cases on a contingency fee basis, so you will not owe legal fees unless you receive compensation.
USES AND SIDE EFFECTS OF GYNECARE MESH
Doctors use transvaginal mesh products like Gynecare mesh to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). SUI, also referred to as stress incontinence, occurs when physical movement or activity causes a person to unintentionally lose urine. Loss of urine could occur because of something as simple as a cough or sneeze. Urine loss can also occur during more intense physical activity, like running or heavy lifting. POP is a condition that causes a pelvic organ to move out of its normal position and press against the walls of the vagina. This happens because the muscles that hold pelvic organs in place have been weakened. POP often occurs after childbirth or surgery. Transvaginal mesh can be placed under the urethra to help prevent stress incontinence. Doctors can also use vaginal mesh to help strengthen the muscles in the pelvic area to support prolapsing tissue caused by POP.COMPLICATIONS FROM VAGINAL MESH
Unfortunately, thousands of women treated with Gynecare mesh and other brands of transvaginal mesh have reported a variety of serious complications, including:- Erosion of the mesh
- Pain, including pain during sexual intercourse
- Infection
- Bleeding
- Perforation of blood vessels, bladder or bowels
- Vaginal scarring and shrinkage
- Problems with urination
- Neuromuscular problems
- Emotional problems
MANUFACTURER HALTS SALE OF GYNECARE MESH PRODUCTS
Between 2005 and 2010, thousands of women reported side effects from Gynecare mesh and other mesh products for treating SUI and POP. Many women who experienced side effects filed vaginal mesh lawsuits against Johnson & Johnson and subsidiary Ethicon, the manufacturer of Gynecare products. Gynecare mesh lawsuits and reports of side effects raised serious concerns about the safety of this product. However, Johnson & Johnson said its decision in June 2012 to discontinue the marketing, manufacturing and selling of certain Gynecare mesh products was not based on concerns about product safety. The discontinued products included:- Gynecare TVT Secure
- Gynecare Prosima
- Gynecare Prolift
- Gynecare Prolift+M
FDA WARNINGS ABOUT GYNECARE MESH
The FDA has been warning about the dangers of Gynecare and other types of transvaginal mesh for several years. In October 2008, the FDA released a Public Health Notification to tell patients and health care providers about side effects from mesh used in urogynecological procedures. The notification said serious complications from using mesh for POP repairs are rare.2011 UPDATE
The FDA released an update on the safety and effectiveness of transvaginal mesh to treat pelvic organ prolapse in July 2011. This document said the risk of side effects is not rare like it had previously said. The FDA based this conclusion on a review of numerous studies and adverse event reports submitted to the FDA between Jan. 1, 2005 and Dec. 31, 2010. For instance, the FDA found multiple studies showing patients who are implanted with mesh to treat POP suffer complications not experienced by patients who undergo surgery without the use of mesh. The FDA also noted increasing numbers of reports of mesh contraction, vaginal shortening, tightening and vaginal pain from the use of mesh to treat POP. The FDA also identified 3,979 reports of injury, death or malfunction from urogynecological mesh products. The FDA's 2011 update tells patients to be aware that mesh surgery could increase the risk of needing additional surgery due to complications. For some patients, another surgery will not fix complications. Patients should immediately report any complications after mesh surgery. They should also continue with any routine or follow-up appointments with doctors. The 2011 update told health care providers to only chose mesh surgery after weighing the risks and benefits versus alternatives. Doctors should also consider that mesh could put the patient at risk of needing more surgery, which will be more challenging because of the presence of the mesh.ADDITIONAL WARNINGS
In May 2014, the FDA released a proposal to reclassify surgical mesh for transvaginal repair as class III devices instead of class II. Class II usually consists of devices with a moderate risk of causing side effects, while class III devices are considered high risk. The FDA also proposed a requirement that manufacturers submit a premarket approval application to support the safety and effectiveness of transvaginal mesh products. These orders were finalized on Jan. 4, 2016 and put into effect. The communication announcing these orders also said there was a significant increase in the number of adverse event reports from mesh for the treatment of POP.STUDIES ON THE DANGERS OF GYNECARE MESH
There are numerous studies that have been published showing the dangers of mesh products like Gynecare mesh. For example, in Jan. 2009, the British Journal of Obstetrics and Gynaecology published a review of 30 studies involving 2,653 women who were implanted with vaginal mesh to treat vaginal prolapse. The study found there was an increasing number of women who needed surgery for complications from the mesh. Another study published in Feb. 2009 in the Journal of Obstetrics and Gynecology found the rate of complications requiring revision surgery was highest in patients who were implanted with vaginal mesh kits, compared to patients who had traditional vaginal surgery without mesh or sacral colpopexy. The same journal published a study in Aug. 2010 showing a vaginal mesh erosion rate of 15.6 percent within three months of the surgical procedure. Researchers questioned the continued use of synthetic polypropylene mesh. The British Medical Journal came out with a study in 2015 showing the use of mesh for POP repair continues to grow, despite FDA warnings. Researchers also found patients who received mesh had a higher chance of needing another surgical procedure due to complications. Researchers studied a group of 7,338 patients who had surgery with mesh and 20,653 who had surgery without mesh. In September 2017, Scientific Reports published a study of all women discharged from the hospital in England between April 1, 2007 and March 31, 2015 after being implanted with surgical mesh to treat SUI. Researchers estimated 9.8 percent of these patients experienced a complication within 30 days or five years of the procedure. If you were implanted with Gynecare mesh and experienced any problems identified in these studies, or other complications, contact our compassionate attorneys in Cincinnati.GYNECARE MESH LAWSUITS AND SETTLEMENTS
There have been tens of thousands of lawsuits filed over transvaginal mesh products. This includes almost 40,000 lawsuits against Ethicon, the subsidiary of Johnson & Johnson that manufactures Gynecare mesh products that have caused a variety of severe complications. The nearly 40,000 lawsuits are part of a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia. An MDL combines cases with similar allegations to streamline the legal process. There were 13,673 lawsuits pending in the MDL as of Feb. 15, 2018. These lawsuits allege Ethicon produced mesh products that caused a variety of complications that required the devices to be removed, including:- Soft tissue injuries
- Tissue erosion
- Bleeding
- Pain
- Infection
