Medtronic Archives - Carey Danis & Lowe

Despite Current Safety Concerns, FDA Approves Newest Pelvic Mesh Product

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Boston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsBoston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsThe US FDA approved Caldera Medical’s latest version of Vertessa Lite mesh in June 2015, even though there is ongoing controversy about the safety of these type of devices.

Caldera Medical, a startup, makes the product to treat Pelvic Organ Prolapse (POP). The large pore mesh corrects the position of vagina after pelvic organs have bulged into the top of the vagina.

On the flip side of this approval is the fact that another mesh manufacturer, Medtronic, recently paid a huge settlement for more than 11,000 vaginal mesh victims.

The FDA has known since 2011 that dire problems result from transvaginal repair for Pelvic Organ Prolapse.

Indeed, they are considering reclassifying pelvic mesh from a moderate risk or class II device, to the more stringent class III device which necessitates a premarket approval (PMA) application.

The premarket approval application will require manufacturers to provide clinical data to show a reasonable assurance of safety and effectiveness for transvaginal mesh used in POP repair.

Unfortunately, with the recent approval of the updated mesh product, Caldera Medical hasn’t been subject to these more stringent testing procedures. The company is one of many named in more than 70,000 lawsuits regarding transvaginal mesh.

The FDA says that the most common problems with these mesh products are erosion through vaginal epithelium, infection, pain, urinary problems and recurrence of prolapse and/or incontinence.

Cary Danis & Lowe will fight pharmaceutical companies on your behalf.

Our attorneys represent women who have suffered emotionally and physically from defective transvaginal mesh. We continue to research cases and are available to discuss your case during a free case evaluation.

Please contact Carey Danis & Lowe by phone at 800.721.2519 or by completing a confidential personal injury claim form.

Drug and Medical Device Cases To Look for in Your Practice

By | Defective Medical Device litigation, Pharmaceutical litigation, Uncategorized

Published May 15, 2012 on InjuryBoard

It is hard to keep track of all of the information we get daily about various drugs and devices. Which ones are potential cases? Who can review them for me?

Here is a list of cases that we are reviewing, and can assist you on. It is not exhaustive.

Depuy Hip Replacements: These hips were installed in thousands of patients without adequate testing. It turns out that the metal components degrade and leave dangerous levels of metal in the blood stream. They also are often ill fitting. In almost every case the replacement needs to be redone.

Actos: This is a diabetes medication that was known to cause bladder cancer.

Zicam: This is a nasal inhaler for colds that causes loss of taste and smell.

Flouroquinolones (Cipro, Levaquin, Avelox): These drugs are known to cause tendon ruptures. The manufacturers have warned since 2009 that they should be used sparingly and only when necessary, yet some doctors continue to overprescribe the drugs. These are now brought by us as medical malpractice claims.

Medtronic Pacemaker Leads: The leads on some of these pacemakers are defective, and can cause death and even when discovered in time can be very difficult to replace.

SSRIs and Birth Defects: Some SSRI medications have been linked to birth defects, and may be actionable.