Popular hair thinning medication, Propecia, interferes with male hormones and causes male sexual dysfunction, according to new research. Propecia (finasteride) is manufactured by Merck & Co.

Although seen by many as a solution to what can be the devastating loss of hair in many, especially young men, noted the Brisbane Times, research has found that Propecia interferes with male hormones, such as testosterone derivatives. This interference has led to a host of adverse side effects that are both worrisome and long-lasting, even permanent. Continue »

Medical device maker, Smith & Nephew, just issued a safety alert for its components in its Birmingham hip implant line, following emergent data on the their failure rate.

The safety alert, does not, pointed out Becker’s Spine Review, include a device recall; however, the device’s failure rate does exceed the U.K.’s National Institute for Health and Clinical Excellence’s benchmark of one percent. Smith & Nephew’s Birmingham Hip Modular Head implants are part of a collection of the manufacturer’s devices that led the way for the metal-on-metal hip implant field in 1997.

In its notice, Smith & Nephew updated indications for its Birmingham Hip Modular Head implants following data from U.K. and Australian registries which revealed a 1.29 percent (U.K.) and 1.12 (Australian Orthopaedic Association’s National Joint Replacement Registry) percent failure rate, said Becker’s Spine Review. The updated indications restrict the device to its Synergy stems and during revision surgeries, in which cases the failure rate drops to 1.07 percent, which is considered acceptable, according to a report issued by MassDevice.com, said Becker’s Spine Review.

Smith & Nephew spokesman, Joe Metzger, told Mass.Device.com, “…we have notified customers and regulatory bodies of a change to the indications for use for the Birmingham Hip Modular Head used during total hip replacement and revision. The potential risks that may result from use of the device have not changed.”

“They may include pain and limited mobility, potentially leading to revision surgery. Females of child=bearing age are at greater risk with metal-on-metal implants. Severely overweight individuals have been observed to be at greater risk of revision surgery,” Metzger also noted. “This modification does not apply to the U.S. market where the Birmingham Hip Modular Head is not approved for use as part of a primary hip replacement procedure,” Metzger told MassDevice.com.

The alert, which did not go as far as to recall the device, is still a blow to industry, which has been mired in controversy, lawsuits, recalls, and growing injury reports and involves a number of device makers, including Johnson & Johnson’s DePuy Orthopaedics’ unit, Biomet, Zimmer, and Wright Medical.

NewsInferno explained that introduction of the Birmingham hip replacement line prompted other device makers to bring metal-on-metal hip devices to market. This summer, MassDevice.com reported that Smith & Nephew rival, Wright Medical Inc., challenged the company’s 2006 application for U.S. Food & Drug Administration (FDA) approval of the Birmingham. The claims included that the study used in Smith & Nephew’s application was insufficient in the areas of safety and efficacy. The FDA did grant two pre-market approvals for the Birmingham in May and October 2006; the latter approval involved additional sizes.

Metal-on-Metal hip implant devices have been blamed for shedding dangerous amounts of metal debris in patients, leading to premature implant failure, adverse local tissue reactions, metallosis, pseudotumor formation, and a host of other long-term health problems.

Arguments are being heard in a proposed Biomet metal-on-metal hip implant multidistrict litigation (MDL). NewsInferno recently wrote that a lawsuit filed in a Nevada federal courtroom claimed the Biomet M2a-Magnum metal-on-metal hip system is both defective and has a high early failure rate; these issues led to serious and debilitating injuries from, yet another, patient implanted with these devices.

The question remains: Will the Biomet M2a-Magnum hip implant device lawsuits will be consolidated in one court? An answer is expected this week following a hearing before the U.S. Judicial Panel on Multidistrict Litigation (JPML) on September 20, 2012, said The Legal Examiner. To date, some 40 Biomet lawsuits have been filed in federal courts nationwide, with plaintiffs alleging that the device leads to metal poisoning—metallosis—and early loosening, which, in turn, necessitate complex and painful revision surgeries. Continue »

A metal-on-metal hip implant warning was just issued in Australia, adding to the controversy surrounding the medical devices.

The Australian Government’s Department of Health and Ageing’ Therapeutic Goods Administration (TGA) recommends that patients implanted with a metal-on-metal hip replacement device speak to their surgeons on an ongoing basis and receive regular ultrasound, MRI, and blood testing, said Top News. “There’s a growing body of evidence that when the ball and socket components wear against each other they can release trace amounts of chromium and cobalt,” said the TGA. Continue »

The U.S. Food & Drug Administration (FDA) just announced that Parkinson’s disease medication, Mirapex (pramipexole), may pose increased risks for heart failure. The agency notified health care professionals following release of recent study results.

A Parkinson’s disease drug, Mirapex is also approved to treat the symptoms of moderate to severe primary restless legs syndrome. Mirapex is in the class of drugs called dopamine agonists and works by acting in place of dopamine. Dopamine is produced by specific areas of the brain that control movement; Parkinson’s disease causes progressive loss of dopamine production in the brain. Continue »

Claims made by Skechers over the company’s Shape Up toning shoes are being questioned. Using celebrity endorsers, such as Kim Kardashian, Brooke Burke, and Joe Montana, Skechers Shape-Ups were heavily touted as a way in which to promote weight loss and muscle tone.

The trademark rounded Skechers’ Shape-Up sole promotes an unstable gait that can lead to injuries, including falls and fall-related injuries, which can allegedly cause hip fractures; rolled and twisted ankles; broken bones, stress fractures, and joint dislocation; and back strain. Continue »

Seven are suing device maker, Stryker, over its recalled Rejuvenate hip implant. Stryker recalled the Rejuvenate and AGB modular-neck hip stems and ceased global distribution of the products this July.

An additional seven plaintiffs have filed lawsuits in Superior Court in Hackensack, New Jersey, alleging that Stryker was negligent in selling them a defective hip replacement device, said NorthJersey.com. The seven additional plaintiffs are from Arizona, Florida, and Minnesota. Continue »

A Skechers toning shoe settlement was granted tentative approval by a federal judge.

Skechers USA Inc. touted the benefits of its Shape-Ups and other toning shoes, using celebrity endorsements that included Hall of Famer quarterback, Joe Montana, and reality star Kim Kardashian. The football star claimed the products enabled him to improve his strength and posture; Kardashian claimed the toning shoes enabled her to drop her personal trainer. Continue »

The judge involved in the multidistrict litigation (MDL) over controversial blood thinner, Pradaxa, has promised to expedite Pradaxa bleeding lawsuits. Pradaxa has allegedly been associated with life-threatening, uncontrolled bleeding.

The MDL now includes 78 cases, said The Madison Record. As NewsInferno recently explained, lawsuits alleging that Boehringer Ingelheim Pharmaceuticals, the maker of Pradaxa, neglected to sufficiently warn users of the blood thinner’s links to deadly bleeding ,were consolidated in an MDL in U.S. District Court, Southern District of Illinois. This means that every Pradaxa bleeding lawsuit filed in federal district courts will now, and in the future, be transferred to the Southern District of Illinois. The cases will be presided over by U.S. District Judge David R. Herndon. The case is entitled IN RE: Pradaxa (Dabigatran Etexilate) Products Liability Litigation. Continue »

Sex abuse advocates, working with victims of the ongoing Orthodox Jewish sex abuse scandal, have canceled a meeting with the Brooklyn district attorney.

Advocates canceled the meeting with Brooklyn DA Charles Hynes, saying he ignored their request for reforms, wrote The New York Daily News. A number of key Jewish advocates expressed anger that the DA will still not release the names of alleged molesters in the tight-knit Brooklyn community. The DA, according to the advocates also refused to work with yeshivas on education programs and to take any action against thoseknown to harass victims, such as rabbis and community officials, The Daily News pointed out. Continue »