Tag Archives: power morcellators

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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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64 More Plavix Patients File Suit Over Bleeding Side Effects

Another Plavix lawsuit has been filed on behalf of 64 Plavix patients who allege bleeding side effects. Plavix (clopidogrel) is a blood thinner prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, such as the heart attacks and strokes it is ...

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Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. ...

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DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).

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Scientist Calls for Federal Regulations for Fracking Pollution

Hydraulic fracturing (fracking) drilling should be governed by federal regulations because its pollution has no awareness of state boundaries.

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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Cancer Groups Issue Statement for Regulation of E-cigarettes

Cancer Groups Issue Statement Calling for Research and Regulation of E-cigarettes

The American Society of Clinical Oncology & the American Association for Cancer Research are calling on the government to regulate e-cigarettes.

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Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Rep. Mike Fitzpatrick Calls for Congressional Medical Device Hearing

Rep. Mike Fitzpatrick Calls for Medical Device Hearing

Representative Mike Fitzpatrick, who has been calling for stricter medical device regulations, has asked the Committee on Energy and Commerce to hold a medical device hearing in order to update laws. This is not the first time Fitzpatrick has taken … Continue reading

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Lawmakers Propose Bill in Effort to Better Detect Medical Device Issues

Bill Proposed to Better Detect Medical Device Issues

New legislation seeks to identify medical device problems as early as possible. Under the Medical Device Guardians Act of 2016, introduced by U.S. Reps. Louise Slaughter, D-N.Y. and Michael Fitzpatrick, R-Pa., physicians would be required to report medical device injuries … Continue reading

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Safety Concerns over Power Morcellators Due to Cancer-Spreading Risks

Power Morcellators Cause Concern on Cancer-Spreading Risks

Power morcellator have been under public scrutiny in the past few years in light of its cancer-spreading risks. These concerns were brought to light by Dr. Amy Reed, who underwent a procedure using a power morcellator, only to discover that … Continue reading

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Power Morcellators can Spread Hidden Uterine Cancers

Power Morcellators can Spread Hidden Uterine Cancers

Power morcellators are surgical devices used to mince up tissue during a minimally invasive surgery, such as a laparoscopic hysterectomy. By cutting up the tissue into smaller pieces, surgeons can remove it more easily through small incisions. However, power morcellators … Continue reading

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Government Accountability Office Asked to Investigate FDA’s Handling of Surgical Tool’s Risks

FDA Omits Serious Side Effects From Levaquin Label

Twelve members of Congress have asked the Government Accountability Office (GAO) to investigate why a device used in gynecologic surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration (FDA). The power morcellator … Continue reading

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