- 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
Just a few months earlier, in March 2012, Bloomberg News reported Johnson & Johnson had been selling Gynecare Prolift mesh from 2005 to 2008 without FDA approval.
This product was not approved by the U.S. Food and Drug Administration (FDA) until May 2008. Johnson & Johnson claimed the product was substantially similar to Gynecare Gynemesh, which had already been on the market. The FDA’s 510(k) approval program allows manufacturers to market products that are substantially similar to other products that have already been approved. However, the Bloomberg report says Johnson & Johnson failed to get approval through the 510(k) program.
If you suffered side effects after being implanted with Gynecare mesh, you may be able to file a Gynecare mesh lawsuit to try to obtain compensation.
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.
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.
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 us about filing a Gynecare mesh lawsuit.
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
The lawsuits also allege Ethicon failed to adequately warn doctors and consumers about the risks of side effects from Gynecare mesh and other types of transvaginal mesh products they manufactured.
The first trial in the MDL was for a Gynecare mesh lawsuit filed by a woman who was implanted with a Gynecare TVT pelvic mesh device in Nov. 2009. On Feb. 18, 2014, Ethicon filed a motion saying the victim failed to present sufficient evidence that the mesh was designed defectively. The judge granted the motion and ruled in Ethicon’s favor.
The second case to go to trial was decided in favor of the victim, who was awarded $3.27 million in compensation in Sept. 2014. The jury ruled Ethicon was liable for selling faulty devices and failing to warn about side effects like pain, bleeding and infections.
The victim was implanted with a Gynecare TVT Obturator transvaginal mesh device in 2011 for the treatment of SUI. Her lawsuit claimed the device caused severe side effects like pelvic pain.
Other Gynecare mesh lawsuits that are not part of the MDL have also resulted in settlements for victims, including a $3.35 million settlement for a South Dakota woman who was implanted with Gynecare Prolift to treat pelvic prolapse. She required 18 operations to repair the damage caused by this product.
This was the first of 1,800 pending cases in New Jersey against Ethicon and Johnson & Johnson over vaginal mesh products.
In April 2014, a Dallas jury awarded $1.2 million to a woman who suffered health problems after an operation to implant a Gynecare TVT-Obturator vaginal mesh sling. The jury held Ethicon and Johnson & Johnson liable for defects.
Schedule a free legal consultation with an attorney to discuss your potential Gynecare mesh lawsuit.
CONTACT OUR ATTORNEYS TODAY ABOUT A GYNECARE MESH LAWSUIT
Ethicon and Johnson & Johnson could be liable for the injuries you suffered after being implanted with a Gynecare mesh product.
Contact our attorneys right now for a free legal consultation to determine if you have a case. If you have grounds for a Gynecare lawsuit and want to move forward, we will not charge for representing you unless you receive compensation.
We are committed to holding negligent product manufacturers accountable for the harm they have caused. We understand how harmful defective products can be and are committed to pursuing compensation for all of the damages you have suffered.