Articles Posted in Medical Devices

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Mesh warnings from the U.S. Food and Drug Administration (FDA) are nothing new, but last week the FDA announced that surgical mesh to treat pelvic organ prolapse (POP) will be reclassified as a Class III (or high risk) medical device. Part of the FDA press release also indicated that manufacturers will need to receive premarket approval (PMA) for their safety and effectiveness in order to keep selling their product.

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Yesterday, a Philadelphia jury ruled Johnson & Johnson (J&J) must pay an injured woman $5.5 million in compensatory damages for its negligence over the defectively designed Prolift pelvic mesh. Today, the jury also awarded her $7 million in punitive damages – a sum intended to punish Johnson & Johnson for having marketed an unsafe product.

This was the second product liability trial involving Prolift mesh, one of the most widely used pelvic meshes produced. The first Prolift trial of Linda Gross in 2013 resulted in a $11.1 million ruling for Ms. Gross but did not find the mesh was defective in its design. That verdict is still under appeal.

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More than 100 plaintiffs have reached a settlement with American Medical Systems Inc, a subsidiary of Endo International PLC which has agreed to pay $830 million as a result of personal injury lawsuits stemming from the health complications allegedly caused by trans-vaginal mesh devices. The company is presently trying to resolve approximately 20,000 ongoing lawsuits that claim the trans-vaginal mesh devices have caused chronic pain, incontinence and other problems such as surgical complications when attempting to remove them. Vaginal mesh devices are a treatment recommended by doctors to thousands of women who were implanted with theses defective devices after suffering from conditions known as “pelvic organ prolapse” and “stress urinary incontinence” which are caused by child birth, hysterectomy and menopause.

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08192014The U.S. Food and Drug Administration (FDA) announced a class I recall of over 100 lot numbers of CareFusion 203 ventilators after a power connection failure was observed in over 250 incidents. Reports list EnVe and ReVel models losing power and shutting off caused by a misalignment of pins where the external power connector meets the input port of the ventilator.

According to the recall notice, the misalignment could cause damage to the pins on the connector and potentially cause a short circuit, which could then prevent the internal battery from recharging and result in an unexpected loss of power. In turn, serious injury or death could result.

Medical professionals, including hospitals and equipment suppliers, were sent a product recall notice earlier this year identifying the lot numbers affected by the recall, which were distributed between December 10, 2010 and August 6, 2014. Device owners should have received a replacement power adapter accessory kits to fix the problem.

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scales-of-justice-balance-transvaginal-mesh-case-300x300A Dallas jury has awarded in excess of $73 million to Martha Salazar for her lawsuit against Boston Scientific for her transvaginal mesh implant. The Dallas jury heard testimonies from Martha Salazar and representatives for Boston Scientific before reaching their decision in favor of Salazar.

Salazar alleged that her operation, which took place on January 17, 2011, was performed by Dr. Jorge Lopez to solve incontinence and instead caused worse medical problems. Medical problems caused by Salazar’s implant include dyspareunia, pain and irreversible nerve damage to femoral and obturator nerve. Some damage caused her to walk with a limp, has gone through numerous surgeries to repair the damage and faces many more.

Among Salazar’s claims are that she was inadequately warned of the dangers of the procedure, as well as belief that Boston Scientific did not properly test the product used in her surgery on humans. She claimed that Boston Scientific withheld information regarding clinical trials, including the lack of study regarding the obturator approach during implant.

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08192014The Food and Drug Administration (FDA) has announced a recall of all units of Expression 1.5cc gel used in intranasal splint procedures. The gel, manufactured by Enhancement Medical, may have been manufactured without proper monitoring of the concentration of hyaluronic acid. Improper concentrations of active ingredients can cause adverse reactions in patients.

An initial recall of certain lots of Expression gel was issued in August 2013 after Enhancement Medical received 68 complaints of patients experiencing the following adverse effects after use.

  • swelling.
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07092014On May 23, the Vascular Solutions company issued a voluntary nationwide recall of 40 lots of their Langston® V2 Dual Lumen Catheters. The company received two reports of incidents where the inner catheter separated from the hub during use, potentially entering the patient’s circulatory system. But in each report, the catheter was retrieved without injury.

The lots recalled were manufactured between January 2014 and April 2014 and included model numbers 5540 and 5550. Vascular Solutions estimates that a total of 8,580 of the recalled catheters were sold between March to May 2014 and approximately 3,847 were unused in the field as of July 3.

The recall includes the following lot numbers:

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spine-CT-scanThe Brainlab, Spine & Trauma 3D 2.0 Navigation Software manufactured by Brainlab AG is being recalled due to faults with programming.

Product recalls have taken place for well over a century, but most involve physical products. This latest revelation is part of a new generation of recalls – those affecting software.

The Brainlab AG application allows healthcare workers to create 3D maps of the inside of a human body, reducing the need for surgical examinations. During surgeries, the software allows doctors to precisely monitor the position and orientation of instruments, making operations less invasive, improving patient recovery time.

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transvaginal-mesh-lawsuit-verdict-johnson-johnson-300x271Johnson & Johnson, a health-care company based in New Jersey, has been ordered to pay $1.2 million to Linda Batiste after a Texas jury ruled that its TVT-O mesh sling had a faulty design.

Produced by Johnson & Johnson’s Ethicon unit, the TVT-O vaginal mesh insert eroded in 64-year-old plaintiff, causing pelvic pain from infection and nerve damage. J&J faces over 12,000 mesh lawsuits – most of which are being heard by a federal judge in West Virginia.

Previously, advocacy group Corporate Action Network had petitioned Attorney General Eric Holder to look into allegations that J&J had tampered with evidence. They accused the company of destroying records that indicated research volunteers were injured during the testing of the product.

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johnson-johnson-destroy-records-300x200Johnson and Johnson, one of the largest names in healthcare, is currently the defendant in a class action lawsuit from women who claim they were injured by the company’s product. Corporate Action Network, an advocacy group that investigates corporate activities, has asked the federal government to investigate what they claim is evidence tampering by the corporation.

Pelvic mesh implants are used to support internal organs that have started to sag in women. The condition is common among older women, and those who have given birth to children. The implants have been the cause of tens of thousands of injuries, according plaintiffs in the case.

“Evidence we’ve presented at trial showed they knew these implants would cause complications and they just didn’t care. Many women are now disabled and they can’t leave their beds, they’re in so much pain. Women have killed themselves because the pain eclipses childbirth pain, it’s that bad,” Jane Akre, founder of an online group for victims, said.

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