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Category: Defective Medical Devices

Morcellator: Johnson & Johnson Recalls Device

08/7/2014
Announcement
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Morcellator is a surgical instrument sold under the name of Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract, and which are used for division and removal of large masses of tissues during laparoscopic surgery.  Morcellators are also used in minimally invasive surgery to perform hysterectomies and in the removal of uterine […]

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FDA Issues Draft Guidance on 510(k)

08/4/2014
Articles
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The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued guidances are non-binding and only “represent the Food and Drug Administration’s current thinking […]

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Study Supports FDA Warning About Power Morcellator

07/29/2014
Articles
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The power morcellator, a surgical device used to mince large masses of tissue inside the body so the material can be extracted through small incisions, has been the center of debate since the Food and Drug Administration discouraged its use in April. A study by doctors at Columbia University, published […]

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FDA Warns Against Power Morcellation

07/11/2014
Articles
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Most women will develop uterine fibroids at some point in their lives.  Fibroids are common, and affect half or more women during their reproductive years.  Most women with fibroids are unaware they have them, but other women can experience symptoms such as anemia, backaches, bleeding between periods, constipation, frequent urination, […]

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Settlement Over Deceptive Implant Marketing

07/10/2014
Articles
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Johnson & Johnson (“J&J”) has reached a four million dollar settlement with the state of Oregon to resolve allegations that J&J improperly marketed its DePuy ASR metal-on-metal hip implants.  J&J has recalled 93,000 ASR hip implants, which had a 12% failure rate in five years. David Hart, Oregon’s Assistant Attorney General […]

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