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manufacturers 48 articles

Medical device makers to pay more for product safety reviews

The Food and Drug Administration (FDA) is doubling its fees to medical device makers who want their products reviewed in order to market them in the United States. The increase will allow the federal agency to hire 200 new full-time employees to carry out more detailed reviews and allow more time for device manufacturers to address concerns about safety issues. The fee increase, which will first have to be approved by Congress, comes just months after the agency’s accelerated approval process for moderate-risk medical devices was criticized for allowing medical devices to be marketed without adequate testing, putting the public’s ... Read More

Medical device makers to pay more for product approvals

Medical device makers who want to have their products reviewed by the Food and Drug Administration (FDA) in order to be sold in the United States will have to pay twice as much as they have in years past. The agency says it is increasing its rates in order to pay for an additional 200 full-time employees to manage the approval process for moderate risk medical devices. The vast majority of moderate risk medical devices are currently approved through an expedited process that grants approval to medical devices if there is a similar product already on the market. While this ... Read More

Hip implant lawsuits mount in Canada and US

Class action lawsuits against the makers of hip replacement systems are mounting in Canada as well as the United States. Different hip implant manufacturers are named in the lawsuits, and some of the plaintiffs allege that their hip replacement surgery made them feel worse, not better. At least four class action lawsuits have been filed against various artificial hip manufacturers in Canada and several others have been filed in the United States, all alleging the hip implants are defective and require revision surgery to remove and replace the devices. Most lawsuits are focused on a newer version of implants that ... Read More

Transvaginal mesh makers ordered to conduct safety studies

The Food and Drug Administration (FDA) has ordered manufacturers of surgical mesh used to treat pelvic floor disorders to conduct three years of trials to determine just how dangerous their devices are and whether they provide any benefit over older methods of treatment. The order comes just months after the FDA began a safety review on the mesh after discovering a five-fold jump in deaths, injuries and malfunctions associated with the devices. Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used ... Read More

Woman sues transvaginal mesh makers for $1.5 million

Manufacturers of surgical mesh used to repair pelvic floor disorders are being sued for $1.5 million by a Louisiana woman who claims the medical device is defective. The lawsuit was filed in Federal Court in New Orleans against Johnson & Johnson Inc. and Ethicon Inc. The woman’s lawsuit claims that Gynecare Prolift Pelvic Floor System, the Gynecare TVT System, the Gynecare TVT Obturator System, the Gynecare TVT Secure System, the Gynecare Prolift Anterior, Posterior, and/or Total Pelvic Floor System, and the Gynecare Prolift + M Pelvic Floor Repair System are defective transvaginal mesh products. Transvaginal mesh is a type of ... Read More

Artificial hip makers pay less to surgeons after settling lawsuit

A 2007 lawsuit charging manufacturers of artificial hips with providing kickbacks to orthopedic surgeons for using their products, has resulted in fewer payments to surgeons the year following the lawsuit, according to a report released today by the Archives of Internal Medicine. Researchers reviewed data from Biomet Inc., Johnson & Johnson’s DePuy unit, Smith & Nephew Plc, Stryler Corp, and Zimmer Holdings Inc. for the years 2007 and 2008. They found that a total of 939 orthopedic surgeons received $198 million from the medical device companies in 2007. A year later, 568 payments were made worth $119 million, plus $109 ... Read More

Lawyers investigating claims of injuries from transvaginal mesh

Attorneys for Beasley Allen Law Firm are currently investigating cases of injury caused by surgical mesh used to repair pelvic floor disorders. Transvaginal mesh is a device used to repair conditions such as stress urinary incontinence and pelvic organ prolapse. The mesh has come under the spotlight recently after an alarming number of complaints to the Food and Drug Administration (FDA) adverse event reporting program, MedWatch. Transvaginal mesh is made of porous absorbable or non-absorbable synthetic material or absorbable biologic material. In the repair of pelvic floor disorders, the mesh is permanently implanted to reinforce the weakened vaginal wall or ... Read More

New baby crib safety guidelines now in effect

A new generation of safer cribs will now be the only cribs available for sale at retail stores across the country. Anyone who manufactures or sells baby cribs is required to meet new and improved crib safety standards approved by the U.S. Consumer Product Safety Commission (CPSC) late last year. The CSPC is an independent agency of the U.S. government created in 1972 through the Consumer Product Safety Act to “protect unreasonable risks of injuries associated with consumer products.” The guidelines were established by the CPSC following numerous crib recalls due to injuries and deaths, mostly due to entrapment hazards ... Read More