Makers of transvaginal mesh products have been ordered by U.S. regulators to conduct studies. Today, the devices are the focus of many hundreds of lawsuits involving dozens of manufacturers. According to Bloomberg, manufacturers of such devices are facing more than 600 lawsuits over alleged transvaginal mesh complications.

Johnson & Johnson, C.R. Bard, Endo Pharmaceuticals Holding Inc., and Boston Scientific Corporation, among others, have just been ordered by the U.S. Food and Drug Administration (FDA) to study links between their vaginal mesh implant products and organ damage, infection, and painful sex rates, said Bloomberg News. Device makers—33 in all—received FDA letters this week, asking them to compile three years of data on implant safety and efficacy, William Maisel, deputy director of science for the FDA’s device-approval center, told Bloomberg News. Continue »

Canadian hip implant lawsuits are on the rise, with patients alleging that their devices break down and leave them in pain. No less than four class action lawsuits are underway against different hip implant device makers.

Some of the lawsuits involve patients whose symptoms worsened after undergoing joint replacement surgery, said CBC News. In one case, not only did symptoms become worse, the corrective surgery left at least one patient with reduced quality of life. CBC News talked to Rob Desborough of Pictou, Nova Scotia, who said that one day, while gardening, his implant fell apart and the revision surgery—to remove and replace the defective device—was “difficult.” Continue »

Some Ohio fracking injection wells have been closed after earthquakes were linked to hydraulic fracturing activities. Ohio is the latest state in a growing number of locations that have seen potential links between increased seismic activity and fracking activities.

According to a number of news outlets, there have been 11 earthquakes near a Youngstown injection well used for the disposal of fracking wasterwater the since March; this weekend’s 4-point quake prompted an immediate shutdown the well, said The Wall Street Journal. Development of such injection wells is on the rise in Ohio, as they are needed to manage the increasing amounts of fracking wastewater being transported to the state from nearby Pennsylania. (Injection wells are different than drilling wells that involve actually fracking for natural gas). Continue »

Stent procedures have been linked to high readmission rates with about one out of every six patients readmitted to the hospital within one month of their original procedure.

Stents are tiny wire-mesh tubes used during heart surgery that prop arteries open after angioplasty, in which blockages are cleared. Some stents are manufactured with a drug coating meant to keep blood vessels from re-clogging. Continue »

A new hip and knee implant study is raising questions about newer model devices that might not perform any better than older generation designs that cost less. As a matter-of-fact, the older, cheaper models might actually last longer. A big consideration given that when a hip or knee implant fails or needs replacing, surgery is required.

The New York Times said that the newly published study reviewed information from Australia’s orthopedic registry and looked at implants that were introduced to the market 2003 – 2007. Metal-on-metal implants are constructed with both a metal ball and metal cup, said The Times, and were intended to be longer lasting than their predecessors. Unfortunately, the newer generation implants are expected to fail earlier, with replacements needed much sooner than the older implants, which generally last for about 15 years, The Times pointed out. Continue »

Following a year of recalls, Johnson & Johnson has implemented yet another. This time, Johnson & Johnson is recalling a massive 12 million bottles of Motrin. It seems the defective Motrin dissolves too slowly.

Johnson & Johnson’s McNeil Consumer Healthcare unit wrote in a statement on its website that product testing indicated that some Motrin caplets might not dissolve as soon as they are supposed to when the mediation nears its expiration date, said Bloomberg Businessweek. Customers do not have to return the painkillers; however, there may be what McNeil described as “a delay in relief” after taking Motrin, spokeswoman Bonnie Jacobs told Businessweek. Continue »

Lawsuits are mounting over Proscar and Propecia, and claims have been filed federally and at the state level. Plaintiffs allege that the drugs are dangerous and that drug maker Merck, knew or should have been aware, but neglected to warn, of side effects that include erectile dysfunction, infertility, depression, and suicide.

Proscar and Propecia, which are known generically as finasteride belong to a class of drugs called 5-alpha reductase inhibitors, or 5-ARIs. Proscar is used to treat enlarged prostate, while Propecia is used to treat male pattern baldness. Continue »

Heart drug, Multaq, is subject to new restrictions, according to federal health officials. New safety warnings are being mandated following a study by drug maker, Sanofi, that linked Multaq (dronedarone) to serious cardiac events as well as a review of clinical trial data by the U.S. Food & Drug Administration (FDA) that revealed a link between Multaq and increased heart attack, stroke, and death in some patients.

Multaq is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.

The new boxed warning stresses study results that revealed that Multaq doubled risks for cardiac complications in patients with permanent AF, said The Associated Press (AP). Permanent AF is a condition in which the heart’s chambers pump out of rhythm. The new label also emphasizes that Multaq is only approved for short-term AF and AFL, a related condition, said the AP.

The FDA announced that it completed a safety review of Multaq that revealed an increased risk of serious cardiovascular events, including death, when used by patients in permanent AF; the FDA’s review was based on data from the PALLAS and ATHENA clinical trials. The revised Sanofi label, which was written collaboratively by the FDA and Sanofi and has been revised with the following changes and recommendations:

• Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
• Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
• Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF).
• Patients prescribed Multaq should receive appropriate antithrombotic therapy.

The FDA initiated its Multaq safety review in January, updating the drug’s label to include “liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Multaq.” In July, the FDA expanding this warning to include heart side effects, following PALLAS study results that revealed that patients taking Multaq for permanent AF were at a two-fold risk of death and increased risks for heart attack and stroke.. PALLAS was ceased over the summer after Multaq patients experienced higher-than-anticipated adverse cardiac events.

Yesterday’s FDA Drug Safety Communication indicated that 25 Multaq patients died during PALLAS, as opposed to 13 in the placebo group. Of those, 14 Multaq patients experienced sudden death or death from arrhythmia, versus 4 in the placebo group. In the Multaq group, 23 patients suffered stroke and 43 were hospitalized with heart failure, versus 10 and 24, respectively, from the placebo group. The FDA also reviewed ATHENA data, which was used to grant Multaq’s approval for temporary AF. The Safety Communication indicated that Multaq patients did not suffer increased cardiovascular death, stroke, or heart failure risks and, because of this, the FDA maintains that Multaq provides a benefit for patients with non-permanent AF.

In the midst of probes, shareholder lawsuits, and broad criticism concerning its Infuse bone growth product, Medtronic is making headlines again. This time, three senators are asking for information on Medtronic’s Infuse product.

Senators Charles Grassley (Republican-Iowa), Herb Kohl (Democrat-Wisconsin), and Richard Blumenthal (Democrat-Connecticut) asked, in a letter described by The Star Tribune as having an “investigational tone,” for very specific information on how Medtronic monitors its products once they are released and for information on Infuse. Continue »

A Class I recall, the U.S. Food & Drug Administration’s (FDA) most serious designation, has been issued for St. Jude Medical Inc.’s Riata leads. The recall involves the performance of Riata® and Riata® ST Silicone Defibrillation Leads. The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction.

Last year, St. Jude sent a letter to physicians explaining that the devices’ cables with newer coating experienced less problems and have almost replaced older versions (the phase-out is expected to be completed by year end); At the time the letter was sent, an FDA spokeswoman said that the issue did not warrant a recall. Continue »