TRANSVAGINAL MESH LITIGATION - ADDITIONAL INFORMATION AND FREQUENTLY ASKED QUESTIONS
What Is Transvaginal Mesh?
Transvaginal mesh ("TVM") is generally a knitted or woven polypropylene material that is surgically implanted into women typically after pregnancy for pelvic organ prolapsed ("POP") and stress urinary incontinence ("SUI"). According to reports, TVM doesn't work because it is not designed to accommodate the motion of the pelvis, and is ill suited to pelvic motions associated with digestion or sex. As a result, tissues and nerves become inflamed, and it is reported that there could be a fibrotic reaction to the mesh.
What Were The FDA Notices?
In October 2008, the FDA issued a public health warning on complications associated with TVM placement of surgical mesh for POP and SUI. The notification described the complications as "rare," and was not specific to any manufacturer or brand. On July 13, 2011, the FDA issued an update to the October 2009 public health warning stating that surgical mesh for TVM repair of POP as an area of "continuing serious concern." The update reclassified the complications as "not rare," and that "transvaginally placed mesh in POP repair does not conclusively improve clinical outcomes over traditional non-mesh repair." In addition, the FDA 7-13-11 update stated:
- Complications associated with TVM are not associated with traditional surgery
- Adverse affects continue despite removal of the mesh
- As much as 10% of the mesh may erode within 12 months of surgery
- 50% of women who have surgery to remove the TVM continue to have complications/side effects because the mesh is often impossible to completely remove as it was partially absorbed
- Complications of TVM for posterior repair (rectal prolapsed) outweigh the reward
- Surgery to implant TVM has a higher incidence of 2nd surgery than any other vaginal surgery
- Incontinence post TVM surgery is more frequent than with traditional methods
The update was not specific to any manufacturer or brand.
What Are Some Of The Symptoms Of Defective Transvaginal Mesh?
Symptoms of defective TVM that may indicate a need for further medical care and possible revision and/or corrective surgery include: severe pain sitting, walking, incontinence, loss of sexual sensation, pain with sexual intercourse, and others. The symptoms could be a sign of: infection, shrinkage, inflammation, damage to nerve endings, and mesh erosion.
Reports indicate that symptoms/complications related to defective TVM begin to manifest within 30-90 days after the surgery to implant TVM.
What Does It Mean To Have Defective Transvaginal Mesh?
Treatment for problems associated with defective TVM includes revision surgery to remove the mesh and/or corrective surgery to trim or resize the mesh. Often patients require multiple surgeries because the mesh becomes imbedded in the vaginal tissues, and revision/corrective surgery is described as difficult. Revision and/or corrective surgery continually results in more scar tissue and aggravates the symptoms. TVM consumers report that often it is difficult to find surgeons willing to do the revision and/or corrective surgery.
Who Are The Manufactures Of Transvaginal Mesh, And What Are The Names of The Tranvaginal Mesh Manufactured By Those Manufacturers?
Manufacturers of TVM that are currently involved in litigation include:
(1) American Medical Systems: (a) Apogee, (b) Perigee, (c) Mini-Arc Sling, (d) Monarc Subfascial Hammock, (e) Influence In-Fast, (f) In-Fast Ultra, (g) IntePro Y Sling, (h) Elevate with IntePro, (I) Intexen, (J) Bio-Arc, (K) Sparc.
(2) Boston Scientific: (a) Pinnacle, (b) Advantage, (c) Obtryx, (d) Lynx, (e) Prefyx, (f) Solyx, (g) Posterior Uphold.
(3) Bard: (a) Uretex, (b) Pelvisoft, (c) Avaulta, (d) Pelvilace, (e) Pelvicol, (f) Align, (g) Pelvitex.
(4) Johnson & Johnson (Ethicon): (a) Gynecare, (b) Gynemesh, (c) Prolene Mesh.
Other TVM manufacturers who are currently not involved in litigation include:
(5) Coloplast (bought Mentor's mesh brands): (a) ARIS TOT, (b) NovaSilk.
(6) Caldera Medical: (a) T-Sling, (b) Desara.
(7) Cook Medical: (a) Stratasis.
(8) Tyco Healthcare: (a) IVS.
How Do I Know What Kind of Transvaginal Mesh That I Have?
There are multiple ways to determine what kind of TVM that you have. First, you may contact the physician that performed your TVM surgery. For privacy reasons, the physician may ask that you inquire in person. Second, we can contact your physician for you. If you would like help contacting your physician to identify the kind of TVM that you have, then please contact SLChapman LLC. You may contact us by e-mail SLChapman LLC at info@lakinchapman.com, or by calling (800) 851-5523.
How Is Transvaginal Mesh Failure Testing And/Or Revision Surgery Being Paid For, And How SLChapman LLC Can Help?
If you have defective TVM, then you will be responsible for all costs for testing and/or revision surgery. However, you may have a strong legal position that warrants additional analysis. At SLChapman LLC, we understand that the damages you have suffered or will be caused to endure as a result of defective TVM far exceed the costs of replacement, and we will work to obtain the maximum award provided for under the law. If you are currently experiencing problems associated with defective TVM, have had revision surgery to remove defective TVM, or have had corrective surgery to correct defective TVM, then you can get help by contacting the experienced lawyers at SLChapman LLC for a free initial consultation. E-mail SLChapman LLC at info@lakinchapman.com, or call (800) 851-5523 today.
Are There Currently Lawsuits Pending Regarding Defective Transvaginal Mesh?
Yes, many lawsuits have been filed nationwide regarding defective TVM. If you are currently experiencing problems associated with defective TVM, have had revision surgery to remove defective TVM, or have had corrective surgery to correct defective TVM, then you can get help by contacting the experienced lawyers at SLChapman LLC for a free initial consultation. E-mail SLChapman LLC at info@lakinchapman.com, or call (800) 851-5523 today.
