Urogynecology Expert Witness Links Woman’s Continuing Pain to Defective Transvaginal Mesh

In this case, a urogynecologic surgery expert evaluates injuries to the plaintiff that were allegedly caused by an improperly designed and manufactured pelvic mesh implant. Plaintiff suffered from a vaginal bulge with falling out symptoms, pain and pelvic pressure and symptoms of stress urinary incontinence, along with menopausal symptoms. She was diagnosed with a bladder hernia into the vagina and a rectal hernia into the vagina. She underwent surgery, in which a biosynthetic support system using polypropylene mesh manufactured by defendants was implanted.

Within a year, plaintiff was treated for polypropylene erosion. She was observed several times with erosion of the mesh, and was also was treated for a tight sling. The sling was not at the midurethra, but had moved to the bladder neck. Granulation tissue was present in the area of erosion, and a second area of erosion of mesh was also found. Part of the mesh had to be surgically removed and an erosion was excised. She later was diagnosed with rectal prolapse, and a surgical resection was done.

Plaintiff currently suffers from pain in the back, stomach, pelvis, rectum and legs, as well as ongoing urinary incontinence.

Question(s) For Expert Witness

1.) Is the defendant’s mesh product defective? How so?

2.) How has this impacted the plaintiff?

Expert Witness Response

It is my professional opinion that the polypropylene mesh used in the defendant’s products is defective as described below.

• The weave of the mesh produces very small interstices which allow bacteria to enter and to hide from the host defenses designed to eliminate them. The bacteria can secrete an encasing slime (biofilm) which further serves to protect them from destruction by white blood cells and macrophages.

• Polypropylene is impure: There is no such thing as pure polypropylene (PP). Polypropylene contains about 15 additional compounds which are leached from the polypropylene and are toxic to tissue which enhances the inflammatory reaction and the intensity of fibrosis.

• Polypropylene mesh was shown to be not inert in 2003 with flaking and fissuring demonstrated by scanning electron microscopy which leads to degradation and release of toxic compounds. This enhances the inflammatory and fibrotic reactions.

• With loss of polypropylene due to degradation, the surface area is greatly increased thus providing greater areas for bacterial adherence and more elution of toxic compounds from the polypropylene and also the freed toxic polypropylene itself, all of which increases the inflammatory reaction and intensity of fibrosis.

• f. Heat used during manufacture begins the process of degradation.

• Predominant infection/inflammation was noted in 2007 in explanted samples of polypropylene.

• The large polypropylene surface area promotes wicking of fluids and bacteria and is a “bacterial super highway” that provides a safe haven for bacteria which attached themselves to the mesh during the insertion process.

I disagree with the defense expert as to plaintiff’s care and the causal relationship between the defendant’s mesh implanted in plaintiff and her injuries. To a reasonable degree of medical probability plaintiff has had many problems due to the defective products and the procedure for insertion.

In summary, to a reasonable degree of medical probability, the bladder irritability, the mesh erosions, the vaginal and back pain and the rectal prolapse are all the result of the insertion of the defendant’s mesh products. Since mesh remains in her body, future erosions or other complications will occur, necessitating additional surgeries well into the foreseeable future. Because of the fragility of plaintiff’s body, much of which has been brought about because of the implantation of the defendant’s product, and the resulting complications, the prospect of future major surgery is not one to be lightly considered.