Articles Posted in Medical Device Defect

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In 2002, the U.S. Food and Drug Administration (FDA) approved the Conceptus Inc., a subsidiary of Bayer since 2013, manufactured Essure Permanent Birth Control System. The contraceptive is marketed as the “only permanent birth control you can get with a non-surgical procedure.” Furthermore, a focal marketing attribute of Essure is that the procedure is quick, most times only lasting approximately 10 minutes and can be executed without the need for any anesthesia. Also, the procedure is done with no need for incisions during the entirety of the process. The procedure consists of implanting a small flexible coil, that reaches 1.5 inches once implanted and expanded. The doctor implants the coil through the cervix and vagina ultimately positioning it at the entrance of each fallopian tube.

According to a clinical study, produced by the makers of the birth control system, Essure was allegedly shown to maintain an almost perfect percentage of effectiveness in preventing pregnancies. Although, many of the women that have used Essure would strongly disagree as well as complain about the various side effects they have suffered from having the procedure.

Since the product’s existence there have been around 10,000 documented complaints due to ineffectiveness and various side effects, even multiple deaths, related to Essure. The side effects, include but are not limited to, are:

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The Michigan based Stryker Corporation, a medical technology firm, has been the under the spotlight due to their medical device recalls. In 2012, Stryker was forced to recall the popular surgical implant or replacement medical products Rejuvenate and ABG II Modular-Neck Hip Stems due to their connection to patient problems and negative side effects.

Rejuvenate and ABG II Modular-Neck Hip Stems were unlike any of the current hip implant technology on the market. At that time the market was known for using a one-piece neck and stem construction, but the Rejuvenate and ABG II Modular-Neck Hip Stems were constructed using a system of multiple stem and neck mechanisms. The multiple components were instrumental in allowing for a more custom fit for implant or replacement patients. The products’ qualities including the system of multiple components, coupled with theoretical stability, longevity and larger range of motion, allowed Stryker Corp. to advertise the Rejuvenate and ABG II Modular-Neck Hip Stems as one of the top of the line performance surgical products, especially to younger patients in need of implant procedures.

Stryker also made their Rejuvenate and ABG II Modular-Neck Hip Stems with an alloy that allegedly was stronger than other alloys being used on that time’s current market. Stryker additionally claimed that their alloy blend “resembles that of bone.” The alloy blend consisted of titanium, iron, molybdenum and zirconium. Stryker maintained that this blend would deter metal corrosion and fretting, which is where small metal flakes break off and enter into the body. Unfortunately, Stryker was incorrect and the alloy blend based products caused serious negative side effects, predominantly the release of combinations of toxic metals into the body of the implant or replacement patient.

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BOSTON SCIENTIFIC TRANSVAGINAL MESH TRIALS

            Mesh trials against Boston Scientific for pelvic mesh products have been met with mixed results. To date twelve cases have gone to a jury against the manufacturer of the recalled Pinnacle system, the Uphold system, and the Obtryx sling.  The Plaintiffs’ have won eight of these cases and the Defendant has won four.

Most recently in Missouri, Boston Scientific prevailed in a case in Kansas City, Missouri. A jury found that the Solyx mesh product, and a C.R Bard mesh product named the Align, were not defectively designed. This trial marked the first time that a mesh trial was conducted against the manufacturers of two different mesh products.

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Transvaginal Mesh Update

As summer ends there is optimism regarding upcoming transvaginal mesh settlements. Recently firms have settled with C.R. Bard, and Coloplast for sums that exceed the previous settlements with American Medical Systems, (AMS).

Recently C.R. Bard settled approximately 3,000 cases for 200 million dollars. This number exceeds the previous per case average set by the American Medical Systems settlement from May of 2014. C.R. Bard manufactured Avaulta mesh for pelvic organ prolapse, and several other products for stress urinary incontinence, such as the Align, and the Ajust. The Naumes Law Group is optimistic that settlements for women who have been injured by products manufactured by Boston Scientific and Ethicon will occur in the near future.

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On February 5-6, 2015, Judge Joseph Goodwin held status conferences in the Boston Scientific, C.R. Bard, and Johnson & Johnson multidistrict litigation mesh cases.  Judge Goodwin had previously urged C.R. Bard to settle its vaginal mesh (TVM) cases.

Judge Goodwin has previously told Bard: “I can’t imagine a corporation facing potentially billions of dollars in verdicts wouldn’t find it advisable to try to achieve a settlement for a much lesser sum.”

Judge Goodwin required all Defendants to bring in house counsel to the conference in attempt to bring resolution to these cases.  While American Medical Systems has already settled its cases for at least 1.3 billion dollars, women across the country are patiently waiting for Bard, Boston Scientific, and Johnson & Johnson to make serious settlement offers.

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The majority of vaginal mesh cases filed in the United States are consolidated in the Southern District of West Virginia in front of the Honorable Joseph Goodwin. The majority of these cases are filed against Boston Scientific, Johnson & Johnson, C.R. Bard, and American Medical Systems. The Naumes Law Group is accepting clients who have been harmed by mesh implanted for pelvic organ prolapse (POP Kits), and stress urinary incontinence (Slings).

Many victims have recently been asking the same two questions related to vaginal mesh implants and the litigation.

The first question is “my doctor told me that my mesh isn’t the mesh that’s on TV.”   Let a Naumes Law Group attorney investigate your claim at no cost to you. We can obtain the implant log and sticker page from your doctor and determine if it is the type of vaginal mesh that is the subject of this litigation.

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Although it sounds unsightly, it is true. Pelvic Organ Prolapse (POP) is a medical condition that occurs when your organ drops out of place in your belly and exerts pressure against the vagina. Some of the organs involved in case of prolapse include are bladder, urethra, uterus, vagina, small bowel, and rectum. It is more common in older women and can occur as result of weakened pelvic muscles due to childbirth, hysterectomy, and menopause.

Doctors now have a technique whereby a transvaginal mesh (TVM) implant is inserted through the vagina to permanently fix POP. While inserting a the mesh through the abdomen is possible, placement of the mesh through the vagina is easier and less invasive.

It does however have its own risks including the product (mesh) being defective, or faulty manufacture recommended surgical technique. The results of surgery gone wrong include serious infection and injury and scarring to vaginal tissue and nearby organs.

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In July of 2012 Stryker Orthopedics announced a recall of its Stryker Rejuvenate and Stryker ABG II hip implant products. The announcement came as a result of a gradual wearing away and corrosion of the company’s Stryker Rejuvenate and ABGII hip replacement products that caused tissue damage, metallosis, and necrosis. Fortunately enough the patients implanted with the defective medical devices will be compensated now that plaintiff attorneys and Styker have reached a settlement agreement.

The settlement agreement reached on November 3, 2014, and executed in New Jersey, provides compensation for nearly 3,000 injured patients. The settlements took nearly four months to negotiate, and was overseen by New Jersey Superior Court Judge Brian R. Martinotti of Bergen County.

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