3 June 2015

Advantage Fit: Controversies, Lawsuits and Health Risks

advangtage fit boston scientific

Advantage Fit is a mid-urethral sling system from Boston Scientific that has been the center of a lot of controversy and concerns following reports of serious health complications.

Advantage Fit is just one example of a ‘transvaginal mesh’, an entire product category that has been hounded by issues and complications. Hundreds of thousands of women have been injured or traumatized by these products and have received settlements as a result. Read on and we’ll look at the role of Advantage Fit in all this and whether you may also be entitled to compensation.

What is Advantage Fit?
Advantage Fit and Advantage Sling System is a transvaginal mid-urethral sling system. Like other transvaginal products, this is a mesh that is intended to be implanted into the vagina to treat POP (pelvic organ prolapse) as well as SUI (stress urinary incontinence).

All these products work on similar principles, providing either a biological or a synthetic mesh structure to give extra support and stability to the inside of the vagina. This then can prevent sagging organs (prolapse) which might place pressure on the urethra or bladder.

In the case of Advantage Fit specifically, the mesh is made from a polypropylene mesh, de-tanged in its suburethral portion to help reduce irritation (theoretically). It is also supposed to resist deformation and have various features – such as a ‘blue centering tab’ to help with the initial insertion.

Complications and Issues
Boston Scientific was actually the first company to release a transvaginal mesh device, which was approved by the FDA in 1996. Unfortunately, that mesh needed to be recalled from the market owing to complications and health problems.
Since then, many other similar products have likewise seen reports of health issues and have been the focus of lawsuits and settlements.

Here, the main issues are those caused by ‘vaginal erosion’ which occurs when the meshes move inside the vagina and wear away the internal walls as well as the nearby organs. This can then lead to a number of serious complications, including:

  • Bleeding
  • Vaginal tightening/shortening
  • Infection
  • Permanent scarring
  • Constant pain
  • Discomfort during intercourse

These are all issues that exist with Advantage Fit and which Boston Scientific is highly familiar with. The company actually discusses many of the potential adverse effects on its website (though you have to download a PDF). Some quotes from the company include:

“Like all foreign bodies, the mesh may potentiate an existing infection.”

“In addition to the above listed potential complications, allergic reaction, fistula, abscess, detrusor instability, pelvic and vaginal pain, dyspareunia, vaginal bleeding, vaginal discharge, dehiscence of vaginal incision, bruising/hematoma, edema and erythema at the wound site, have been reported due to suburethral sling procedures.”

Despite acknowledging these problems, and despite the FDA stating that the complications are ‘not rare’ and that the products are ineffective, Boston Scientific continues to sell the Advantage line of meshes from its site.

If you have been negatively affected by Advantage or any other Boston Scientific devices, then there is a good chance you may be entitled to compensation. Get in touch today and we will happily give you a free consultation.

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