Vaginal Mesh Lawsuits filed

More than 400 lawsuits have been filed in New Jersey state court against Ethicon, Inc.  and Johnson & Johnson (Ethicon, Inc. is a wholly owned subsidiary of Johnson & Johnson). 

The complaints allege that Johnson & Johnson was aware that their products were risky and dangerous but continued to manufacture and market them.  The specific line of mesh products in question were: Gynecare Prolene mesh, Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare TVT sling and other pelvic mesh product manufactured by Ethicon. 

Some of the symptoms reported by patients of these mesh products include infections, pelvic pain, urinary complications, and erosion of the mesh device.  Earlier this month the FDA officially advised against using these mesh products as a means to repair pelvic organ prolapse or for weakened vaginal tissues due to childbirth, hernias, etc.   

Johnson & Johnson isn't the only company under fire for manufacturing and marketing their transvaginal mesh products.  C.R. Bard, Boston Scientific, and American Medical Systems (AMS) have also allegedly manufactured defective mesh products.

There are two important steps to take if you have been negatively impacted from your transvaginal mesh implant.  First and foremost, it is critical that you visit your physician as soon as possible.  Second, if you're interested in seeking recovery from the company that is responsible for your injury, you will need to speak with a successful injury lawyer; preferably a vaginal mesh injury lawyer with a track record of maximizing settlements for their clients.

Vaginal Mesh Failure Rate - 10%

The FDA is now reporting that up to 10% of vaginal mesh implants have been eroding and have officially advised against using them. 

Often times, medical devices don't require the same scrutiny and approval process as prescription drugs and can be rushed to market without adequate testing (note: this excludes devices that are considered 'most risky' such as pace-makers and breast implants). 

As unfortunate of a situation as vaginal mesh implants have become, hopefully some good will come out of this.  There needs to be greater oversight and consumer protections in place to protect against future incidents involving medical devices.

Over the last 5 years, there have been over 100 recalls on medical devices that the FDA cleared.  Of those 100 recalled devices, only 21 required patient testing before receiving their approval.

In 2010 alone, there were over 100,000 vaginal mesh implant patients in the United States. 

If you have experienced any pain or discomfort from your vaginal mesh implant, it is important that you visit your physician as soon as possible.  If you're interested in seeking additional recovery from your injuries, it is advisable to speak with a qualified vaginal mesh lawyer, preferably one who offers free consultations and one that doesn't try to make you part of a class action lawsuit.

FDA Alert - Vaginal Mesh

On July 13th 2011, the FDA issued a safety communication regarding 'Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse'.

In other words, serious complications have been linked to the use of vaginal mesh or transvaginal mesh.  As discussed previously, this vaginal mesh is an implant used to strengthen vaginal tissue that can weaken due to childbirth, hernias, etc.  According to the FDA, the purpose of their "serious concerns" are specific to pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  


The most common complication that was reported for these vaginal mesh implants was an erosion of the device through the vagina, also known as a protrusion.  The vast majority of these reports came between 2008 and 2010.


Some of the most important revelations from the FDAs investigation (taken directly from the FDAs website) are as follows:

• Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
• Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
• There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
• While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

 Patients that experienced either mesh erosion or mesh contraction reported severe pelvic pain and/or discomfort.

If you have had a vaginal mesh implant and have suffered from any discomfort, it is important that you contact your physician immediately.  There are surgical steps that can be taken to repair this damage and/or reduce the pain or discomfort.  If you are interested in legal remedies from such complications, it would be best to speak with a vaginal mesh lawyer.

If you have not had a mesh implant but are considering doing so, please be aware of the alternatives (such as biologic grafts) as well as asking your physician the appropriate questions (recommended by the FDA):

• Are you planning to use mesh in my surgery?
• Why do you think I am a good candidate for surgical mesh?
• Why is surgical mesh being chosen for my repair?
• What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
• What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
• Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
• If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
• What can I expect to feel after surgery and for how long?
• Which specific side effects should I report to you after the surgery?
• What if the mesh surgery doesn’t correct my problem?
• If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
• If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
• If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Why are Vaginal Mesh Implants used?

Vaginal Mesh Implants are used to strengthen vaginal tissue.  This tissue can become weakened, especially after childbirth, hernias, etc and the mesh implant can reinforce and re-strengthen this tissue.  

The vaginal mesh itself is porous to allow the body's own tissue to grow into the mesh. This is intended to create an even more reinforced structure.

Sometimes vaginal mesh implants are used when there is a vaginal prolapse.  A vaginal prolapse is a condition where the bladder, uterus and/or bowel distends into the vagina. 

A vaginal prolapse does not guarantee the use of a mesh implant.  Alternatively, biologic grafts can be used to re-strengthen vaginal tissues.  To determine whether a mesh implant or biologic graft was used you should consult your physician; however, generally biologic grafts were used if the surgery was performed through the the vaginal route.  If you had robotic surgery, then there is a higher liklihood that mesh was used.