AlphaGEMS Contamination Lawsuits
Amniotic Therapies LLC Products Contaminated with Mycoplasma Hominis Bacteria
If you underwent medical treatment (including orthopedic surgery) that involved AlphaGEMS – an amniotic therapy product – and developed an infection of Mycoplasma hominis, now is the time to speak with an attorney from Spangenberg Shibley & Liber LLP about your legal rights and options.
AlphaGEMS, which refers to a variety of products from Amniotic Therapies LLC, was found by the FDA to contain a highly infectious bacteria: Mycoplasma hominis. M. hominis is a bacteria commonly found in the female genital tract. AlphaGEMS is a biologic drug made from the amnion derived from amniotic tissue recovered from caesarean section births.
When M. hominis is introduced through unnatural means, such as contaminated amniotic therapy products, it can lead to severe infection and devastating health complications. If you contracted an infection after amniotic therapy using AlphaGEMS, speak with an attorney immediately.
Understanding the Risks: Treatment, Contamination & Infection
Amniotic stem cell therapy can effectively treat a variety of conditions, including chronic tendinitis, chronic inflammatory disease, chronic tendinosis, and degenerative joint disease. Along with other uses, AlphaGEMS can create adhesion barriers near damaged nerves to promote tissue healing. Additionally, AlphaGEMS are commonly implemented in orthopedic surgery.
According to an FDA inspection and warning, Amniotic Therapies LLC marketed and sold products contaminated with dangerous M. hominis bacteria. The FDA also noted that Amniotic Therapies failed to comply with CGMP (current good manufacturing practices) when it processed and sold AlphaGEMS products. These failures include:
- Failing to implement procedures to prevent contamination of purportedly “sterile” products
- Failing to test products for cross-contamination, even though contamination was possible
- Failing to ensure products had the quality, purity, and strength Amniotic Therapies advertised
- Failing to maintain oversight of laboratory testing, sampling, product containers, materials, etc.
When to Speak with a Cleveland Alphagems Infection Attorney
Have you developed an infection after receiving treatment with amniotic therapy? Spangenberg Shibley & Liber LLP would like to hear from you.
We invite you to contact us by phone at (216) 600-0114 or by filling out our free consultation form.
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