Category Archives: Breast Implants

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR

Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.

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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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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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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

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Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...

Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims

The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial ...

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Fracking Should be Kept 600m From Aquifers, Study Says

New research on the safety of hydraulic fracturing (fracking) suggests new wells should not be dug within 600 meters of a water aquifer because underground fractures can extend about that far from a dug well. According to a report from UK’s The Guardian newspaper, researchers and geologists at Durham University have ...

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British Women Warned on Silicone Breast Implants After Cancer Death

Women in the United Kingdom (U.K.) are being warned to check in with their doctors if they have received a French-manufactured silicone breast implant known as the Poly Implants Prothèses, or PIP. The silicone breast implants have been linked to … Continue reading

Posted in Breast Implants, Defective Medical Devices |

FDA Panel Calls for Further Study of Silicone Breast Implants

Safety studies of silicone gel breast implants will continue, and despite concerns about their safety, the controversial devices will be permitted to stay on the market, the U.S. Food & Drug Administration (FDA) announced yesterday. The announcement came after an … Continue reading

Posted in Breast Implants, Defective Medical Devices |

Public Citizen Opposes FDA on Silicone Breast Implants

The group Public Citizen is blasting the U.S. Food & Drug Administration (FDA) for giving < "">silicone breast implants its seal of approval last week, citing the devices’ association with a variety of complications, including a rare type of lymphoma. … Continue reading

Posted in Breast Implants, Defective Medical Devices |

FDA Says Silicone Breast Implant Recipients Must be Monitored for Complications

In an update on the safety of < "">silicone gel breast implants, the U.S. Food & Drug Administration (FDA) is warning that the devices come with certain risks. It is likely, the agency said, that eventually women who receive silicone … Continue reading

Posted in Breast Implants, Defective Medical Devices |

Study Sees Link between Breast Implants, Rare Immune System Cancer

A new study has confirmed a link between < "">breast implants and anaplastic large cell lymphoma or ALCL. However, a panel that reviewed the research found that it does not yet prove that breast implants cause ALCL, or suggest what … Continue reading

Posted in Breast Implants, Defective Medical Devices |

Questionable Breast Implant Lymphoma Info Removed from Groups’ Websites

Two plastic surgery groups have removed information that downplayed the risks of a rare type of < "">lymphoma linked to breast implants, following a discussion with the U.S. Food & Drug Administration (FDA). The group Public Citizen had complained to … Continue reading

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Breast Implants Gave Me Lymphoma, Breast Cancer Survivor Says

A Florida woman believes the < "">breast implants she received in the wake of a mastectomy caused her to develop another form of cancer. Sherry Kellogg, a 48-year-old breast cancer survivor from North Palm Beach was diagnosed with anaplastic large … Continue reading

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Breast Implant Cancer Risk May be Downplayed by Plastic Surgeons, Group Says

The link between < "">breast implants and a rare form of lymphoma may be being downplayed by some plastic surgeons, according to a leading consumer advocacy group. According to a letter from Public Citizen to the head of the U.S. … Continue reading

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Lymphoma Latest Breast Implant Worry

< "">Breast implants, especially the silicone variety, have long been the subject of safety concerns. Now there’s a new one – a type of lymphoma called anaplastic large cell lymphoma (ALCL). According to the U.S. Food & Drug Administration (FDA), … Continue reading

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