New Jersey based C. R. Bard is a worldwide creator and distributor of medical products. Founded in 1907 by Charles R. Bard, the company specializes in creating surgical, vascular, oncology, and urology devices.
The Align Urethral Support System is one of Bard Medicals various products offered to treat stress urinary incontinence, or SUI, in female patients. Stress urinary incontinence is the most common urinary incontinence and affects the quality of life of many women it afflicts.
The Align Urethral Support System uses a mesh sling implanted surgically to support the patient’s urethra; this sling is supposed to be a permanent surgical solution for losing bladder control. Unfortunately, the mesh sling used in C.R. Bard’s Align (and all transvaginal mesh slings) has been discovered to increase the risk of injury when compared against other non-mesh treatment options.
According to adverse event reports submitted to the United States Food and Drug Administration, these injuries have all been reported in relation to transvaginal mesh surgery (including Bard’s Align Urethral Support System):
- Mesh Erosion (the expulsion of the mesh implant through the vaginal walls)
- Organ puncture (bowels, bladder, and vaginal wall)
- Pain (lower back pain, vaginal pain)
- Dyspareunia (extreme discomfort during sexual intercourse, sometimes pain to male partner’s penis as well)
- Emotional problems
- Neuromuscular problems
- Shrinkage or scarring of the vagina
- Chronic vaginal bleeding
- Abnormal discharge from vagina
- Reoccurrence of stress urinary incontinence or pelvic organ prolapse (return of the initial condition that Align was intended to permanently treat)
Transvaginal Mesh Timeline
- 2005 to 2008: FDA received over 1,000 reports from nine surgical mesh manufacturers about complications related to the device and its treatment of POP and SUI.
- 2008 to 2010: FDA received 2,874 more reports of adverse complications linked to transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the total adverse reports to over 3,800.
- 2010 Study: A study featured in the Obstetrics & Gynecology journal had to be terminated due to the extent of injuries to participants who received the transvaginal mesh patch. Of the women treated with the surgical mesh, 15 percent experienced erosions, and other complications included two cystotomies (bladder incision) and one blood transfusion.
- 2011 FDA Alert: Serious and painful complications are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. The FDA also found the risky surgical mesh treatment of POP to be no more effective than traditional treatment.
CR Bard (with Sofradim Production S.A.S. and/or Tissue Science Laboratories Limited) Products that are Subject of Litigation:
- Align Urethral Support System
- Align TO Urethral Support System
- Avaulta Anterior BioSynthetic Support System
- Avaulta Posterior BioSynthetic Support System
- Avaulta Plus Anterior BioSynthetic Support System
- Avaulta Plus Posterior BioSynthetic Support System
- Avaulta Solo Anterior Synthetic Support System
- Avaulta Solo Posterior Synthetic Support System
- InnerLace BioUrethral Support System
- Pelvicol Acellular Collagen Matrix
- PelviLace BioUrethral Support System
- PelviLace TO Trans-obturator BioUrethral Support System
- PelviSoft Acellular Collagen BioMesh
- Pelvitex Polypropylene Mesh
- Uretex SUP Pubourethral Sling
- Uretex TO Trans- obturator Urethral Support System
- Uretex TO2 Trans-obturator Urethral Support System
- Uretex TO3 Trans- obturator Urethral Support System