Bayer ends U.S. sales of Essure permanent birth control implant
Posted in Drug & Medical Devices on July 24, 2018
[caption id="attachment_13675" align="alignright" width="300"] Image: Bayer Healthcare Pharmaceuticals, Inc.[/caption] Pharmaceutical giant Bayer recently announced it would no longer sell its controversial Essure® contraceptive device in the United States. The decision follows years of concerning reports of dangerous complications and injuries. (more…)
5 Things You Need to Know About Hernia Mesh
Posted in Drug & Medical Devices on October 7, 2016
Physiomesh®, a surgical mesh commonly used in laparoscopic procedures to repair hernias, was recently withdrawn from the market. The products may be off the market, but anyone who underwent surgery prior to the withdrawal could still be at risk of suffering serious complications and injuries. Here are five things you need to know about the hernia...
Pelvic Organ Prolapse: What You Need to Know
Posted in Drug & Medical Devices on May 20, 2016
What to know if you’ve suffered pelvic organ prolapse Pelvic organ prolapse occurs when an organ, such as the bladder, drops from its normal position and pushes against the wall of other organs and tissue. Though it is an important medical issue to address, the device commonly used to treat this condition poses serious...
Hidden cancer risks for Hysterectomy and Fibroid Removal
Posted in Drug & Medical Devices on July 10, 2015
Uterine cancer is the fourth most common cancer in women in the United States and the most commonly diagnosed gynecologic cancer. Prior to a hysterectomy or fibroid removal (myomectomy), the FDA estimates that approximately 1 in 350 women have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. Stages of Endometrial...
J&J Pulls Hysterectomy Tool Due to Cancer Risk
Posted in Drug & Medical Devices on August 1, 2014
Johnson & Johnson has asked all hospitals to return a surgical device that can spread cancer in women being treated for uterine growths called fibroids. The company has instituted a voluntary “worldwide market withdrawal” of the surgical tool known as a laparoscopic power morcellator. During laparoscopic hysterectomies and myomectomies, surgeons use a power morcellator...
$100M NuvaRing Settlement
Posted in Drug & Medical Devices on February 10, 2014
There may finally be a resolution for the thousands of NuvaRing ® users who filed product-liability claims against Merck & Co., alleging the contraceptive device caused blood clots that caused heart attacks, or led to death in some cases. Last week, the pharmaceutical giant announced it would pay $100 million to resolve nearly 4,000 cases,...
Surgeon Performed Unnecessary Operations, Took Kickbacks
Posted in Drug & Medical Devices, Medical Malpractice on November 4, 2013
Nearly 30 patients in California have sued neurosurgeon Dr. Aria Sabit for medical malpractice; alleging he subjected them to needless spinal surgeries using implants supplied by a company from which he profited. Dr. Sabit has already settled six of the cases out of court for undisclosed amounts. In the latest suit, an elderly patient...
Medical Apps – Who’s Responsible?
Posted in Drug & Medical Devices on September 26, 2013
FDA looking at mobile medical applications From programming your DVR to dealing with a car accident, these days there seems to be an “app” for everything. Now, according to the U.S. Food and Drug Administration, when a mobile device runs certain medical applications, it will be subject to FDA oversight. The FDA has...
FDA to Track Medical Devices
Posted in Drug & Medical Devices on September 24, 2013
The Food and Drug Administration (FDA) has issued a new rule requiring that most medical devices distributed in the United States carry a unique code. The code, also known as a unique device identifier (UDI), will include information about each specific device, including: model number, lot or batch number, serial number, the date the...
Johnson & Johnson Considers $3 Billion Settlement
Posted in Drug & Medical Devices on August 21, 2013
Healthcare giant Johnson & Johnson is reportedly contemplating a massive settlement agreement with patients injured by their DuPuy unit’s ASR Hip Implant. Bloomberg News reports that “five people familiar with the matter” revealed that J&J may be willing to pay more than $300,000 per case, pushing the total settlement amount over $3 billion if...