Transvaginal Mesh

Transvaginal mesh was implanted through the vagina to repair pelvic organ prolapse. In April 2019 the FDA ordered the remaining makers to stop selling it after finding they hadn't shown it was safe and effective. People who already have the mesh can develop erosion, pain and scarring, and some need surgery to remove it. A transvaginal mesh lawyer looks at the product, the complications and the timeline.

What transvaginal mesh is

Transvaginal mesh was implanted through an incision in the vaginal wall to support organs that had dropped, a condition called pelvic organ prolapse. It was permanent and meant to reinforce the weakened vaginal wall1. This page covers that use only. Mesh slings for urinary incontinence and mesh placed through the abdomen for prolapse are different procedures, covered on the pelvic mesh page.

The FDA's 2019 order and what it covers

The FDA reclassified mesh for transvaginal prolapse repair as a Class III, high-risk device in 2016. On April 16, 2019, after reviewing the companies' premarket approval applications, it ordered all remaining makers of this mesh to stop selling and distributing it immediately. The products named were Boston Scientific's Uphold Lite and Xenform and Coloplast's Direct Fix Anterior. The FDA found the companies had not shown a reasonable assurance of safety and effectiveness, and the products were withdrawn1.

The FDA says it continues to believe the benefits of transvaginal prolapse mesh don't outweigh the risks2. No FDA-approved mesh for transvaginal prolapse repair is marketed in the United States1.

Key dates

1. 2016

   FDA reclassifies transvaginal prolapse mesh as Class III1.

2. Apr. 16, 2019

   FDA orders remaining manufacturers to stop selling it.

3. After the order

   Manufacturers withdraw the devices; FDA continues to monitor people who already have them.

The order covered prolapse mesh placed through the vagina. It did not cover mesh slings for incontinence or abdominal prolapse mesh.

Complications reported with transvaginal mesh

Erosion of mesh through the vaginal wall is the most commonly reported mesh-specific complication in prolapse surgery with mesh. The FDA has reported that abdominal prolapse surgery with mesh appears to have lower rates of mesh complications than transvaginal surgery2.

The FDA tells people who have transvaginal mesh to keep up with routine check-ups and to tell their provider about these symptoms1:

• Vaginal bleeding or discharge that doesn't go away
• Pain in the pelvis or groin
• Pain with sex

Other problems described in mesh cases include infection, scarring that tightens or shortens the vagina, urinary or bowel problems and damage to nearby organs. Whether any of these happened, and why, depends on the exam and imaging in each person's records.

Revision and removal

Exposed mesh is sometimes treated with vaginal cream or an office procedure to trim it. Some people need surgery in an operating room to remove part or all of the mesh2. Because the mesh is designed to become part of the surrounding tissue, complete removal may not be possible, and removal may not resolve every symptom. The excision report, which describes what the surgeon found and took out, is often the most important record in a transvaginal mesh claim.

Transvaginal mesh at a glance

What it treated

Pelvic organ prolapse.

How it was placed

Through the vagina.

U.S. status

No longer sold since the FDA's April 2019 order1.

Most common mesh problem

Erosion through the vaginal wall2.

Who may have a transvaginal mesh claim

• You had mesh placed through the vagina to repair prolapse
• An exam found exposure, erosion, shrinking or scarring tied to the mesh
• You needed trimming, excision or repeat surgery
• You have lasting pain, pain with sex or urinary or bowel problems documented by a doctor

The procedure date matters. Whether a new claim is possible depends on the product, the timing, the state and any earlier claim or release.

Who may be responsible

An investigation may look at the company that made and sold the specific product named in the implant record, and at what it knew and disclosed about the risks when your surgery happened. Questions about a surgeon's choices follow separate medical malpractice rules.

Filing deadlines for transvaginal mesh lawsuits

Deadlines vary by state and by when you learned of the injury and its possible cause. Examples:

• Arizona: generally two years for personal injury and wrongful death3.
• California: two years for injury to or death of a person caused by another's wrongful act or neglect4.
• New York: three years for personal injury5, with a separate rule that runs from discovery for injuries caused by the latent effects of exposure to a substance in the body6.
• Texas: two years for personal injury and wrongful death7, and most product liability claims must be brought within 15 years of the product's sale8.

Some mesh complications appear years after surgery, and discovery rules may affect when the clock starts. An earlier claim or release can also matter. Ask a transvaginal mesh attorney to review your dates early.

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Records that help a transvaginal mesh review

Records worth gathering

Implant surgery

• Operative report showing a vaginal approach
• Implant log naming the mesh product
• Prolapse diagnosis

Complications

• Gynecology or urogynecology exam notes
• Imaging
• Excision or revision operative report and pathology

History

• Any earlier claim forms or settlement papers
• Pelvic floor therapy and pain management records

What happens after you contact CBW Law

How a review works

1. Tell us what happened

   Share what you remember about the mesh, the problem and the treatment that followed. You do not need every record first.

2. We identify the device

   We work to confirm the maker, model and lot or serial number, and whether any recall or safety notice covers it.

3. We gather records

   With your permission, we request operative reports, imaging, device data and other records from your providers.

4. We explain what we see

   We tell you what the records show, what questions remain and what options may be open, including deadlines.

The 2019 order stopped future sales. It is not a finding that a particular person's mesh caused a particular injury.

Plain English

Medical, Health & Insurance

Terms you may see in a transvaginal mesh case.

Conditions

Pelvic organ prolapse

When pelvic organs drop and press against the vaginal wall.

Vaginal shortening

Narrowing or shortening of the vagina, sometimes from scar tissue.

Treatments

Partial excision

Surgery that removes only the exposed or problem section of mesh.

Complete excision

Surgery that tries to remove all of the mesh; not always possible.

Regulatory terms

Class III

The FDA's highest-risk device class, which requires premarket approval1.

Premarket approval

The FDA's review requiring reasonable assurance of safety and effectiveness.

Questions

Transvaginal mesh lawsuit questions

Short answers to the questions people ask first.

Was transvaginal mesh recalled?

In April 2019 the FDA ordered the remaining makers of mesh for transvaginal prolapse repair to stop selling it, and the products were withdrawn. People who already had mesh were told to continue routine care.

Does the 2019 order apply to my bladder sling?

No. The order covered prolapse mesh placed through the vagina. Slings for stress urinary incontinence were not included.

Should I have my transvaginal mesh removed?

The FDA has not advised removal for people without problems. Removal is a medical decision for you and your doctor.

What symptoms should I report?

The FDA lists persistent vaginal bleeding or discharge, pelvic or groin pain and pain with sex.

Can I still file a transvaginal mesh lawsuit?

It depends on your state, your dates and any earlier settlement or release. A transvaginal mesh lawyer can review your history.

Is a past settlement program still open?

Don't assume so. Settlement programs have their own deadlines and terms, and a transvaginal mesh attorney has to check what applies to you.

Can mesh be completely removed?

Not always. Mesh is designed to integrate with tissue, and removal can be partial.

Do I need a transvaginal mesh attorney if my mesh was trimmed in the office?

Any treatment for exposure is part of the record. A transvaginal mesh attorney can review it with the rest of your history.

What if I don't know which mesh I have?

The operative report and implant log usually say. We can help request them.

What does it cost to contact CBW Law?

Telling us your story costs nothing, and contacting us does not create an attorney-client relationship.

Tell Us Your Story

If transvaginal mesh caused erosion, pain or more surgery, a transvaginal mesh attorney can review what happened.

Tell us what happened. CBW Law will review your information and explain what we see. Submitting information does not establish an attorney-client relationship or guarantee representation.

Tell Us Your Story →Call (800) 476-2416

This page is general information about transvaginal mesh. It is not legal or medical advice and does not create an attorney-client relationship. The FDA's 2019 order and a complication or removal surgery do not, by themselves, establish that a particular product caused an injury or that anyone is legally responsible. Talk to your doctor before any decision about your mesh. Laws and deadlines differ by state, and no outcome can be promised.