Zimmer Biomet® has announced it is recalling its SpF PLUS-Mini® and SpF XL IIB® implantable spinal fusion stimulators due to higher than allowed levels of harmful chemicals that may be toxic and deadly to tissues and organs. The FDA has indicated that use of the affected products may cause serious adverse health consequences that include, but are not limited to, chronic infections, additional surgery(ies), hospitalization, paralysis, and even death in some cases.
Numerous "big-pharma" companies marketed various transvaginal mesh products to tens of thousands of women and their physicians claiming that it would be a "quick fix" for pelvic organ prolapse, stress incontinence, and other related medical issues. In theory, a simple piece of mesh would be implanted into the woman's body to support the pelvic organs. Now these same women who had hoped for an answer to health concerns are being adversely affected by serious complications and problems associated with the mesh. These complication are both painful, and very difficult to fix.
Numerous women throughout the United States have been the recipient of an implanted vaginal sling that was designed to repair pelvic organ prolapse and/or stress urinary incontinence. The slings and mesh products have been developed and marketed by a number of companies, including Johnson & Johnson. Reports of problems with the mesh and sling devices began pouring in shortly after these products became widely used. Complications may include infection, erosion of the mesh, continued urinary problems, pelvic pain, hardening of the mesh material, and injuries to nearby organs.