As a consumer society, America is reliant upon its medical, pharmaceutical, household, and transportation products. Unfortunately, with thousands of new products being released to the market every year, there comes hundreds of recalls. Many of these recalls, especially the drug and medical recalls, are life-threatening.
TransVaginal Mesh Warning
A warning was recently issued by the FDA against the use of TransVaginal Mesh. Possible severe side effects, such as vaginal mesh erosion (the painful splitting of vaginal skin or tissue), infection, pelvic organ prolapse, and urinary incontinence, have been linked to the use of this medical product.
The FDA advisory was issued after nearly a dozen different medical device manufacturers witnessed one or more of these affects. A clinical trial also showed a higher than acceptable percentage of women who experienced adverse affects with the vaginal mesh device within the first three months of implantation. According to one report, about "10% of women experienced erosion within a year after surgery." This figure included synthetic and biologic types of mesh.
The FDA received almost 3,000 adverse events reports (AERs) regarding the mesh in the past 3 years. The most common problems occurred when Transvaginal mesh was used for prolapse repair (a common surgery for women in their 50s and 60s). The most common adverse side effects of TransVaginal Mesh include:
- Erosion of the mesh from the soft tissues
- Pain (including during intercourse)
- Infections in the area of the mesh
- Urinary tract problems
- Damage to nearby organs
DePuy ASR Acetabular Hip Recall
DePuy, a subsidiary of Johnson & Johnson, issued a voluntary recall in August of 2010 of its ASR Acetabular and ASR Resurfacing hip replacement systems. These hip replacement systems, which were first introduced in 2003, experienced a 49% failure rate in most patients within 3 years of implantation. Lately, complaints against DePuy, and other metal-on-metal hip implants, have risen exponentially. The FDA received more Adverse Event Reports (AERs) in the last 6 months against metal hip implants than in the previous four years combined.
Nearly 90,000 DePuy hip replacement systems were distributed world-wide, 40,000 of which were used in the United States.
This is one of nearly 20 recalls associated with Johnson & Johnson in the past two years.