Articles Posted in Medical Device Recalls

Women looking for a simple alternative to traditional methods of sterilization have turned to the Essure Permanent Birth Control System, which is marketed and sold by Bayer. The contraceptive device was originally developed by Conceptus Inc. and approved in 2002. Bayer purchased Conceptus and the rights to the Essure System in 2013 and is now under fire for numerous complications that women using the system have suffered. These complications are so severe that the FDA has implemented a black box warning for the devices— which requires patients to sign a waiver stating that they have been notified of the risks associated with the devices prior to use.

How the Essure System Works

The Essure Permanent Birth Control System is a non-hormonal birth control method that prevents pregnancy through sterilization. Two flexible coils are inserted into the fallopian and over time, scar tissue develops around the coils and causes permanent infertility by creating a barrier that prevents eggs from reaching the uterus. The simple outpatient procedure has made the system an attractive alternative to tubal litigation and the devices can be inserted without any need for anesthesia.

3M Bair Hugger manufactures and sells a forced air warming blankets that are used during implant surgeries nationwide. The blanket helps patients who are under anesthesia regulate their body temperature while it prevents hypothermia. Using a surgical hose, the system forces hot air into the disposable blanket draped over the patient’s larger body areas during surgery. The warming blanket has been used by many surgeons during millions of surgical procedures each year as a way to reduce the chance of hypothermia, when the patient loses body heat at a rate faster than it can be produced.

While designed to reduce the potential risks of developing an infection, the device might actually cause an infection by blowing highly contaminated bacteria-laden air from the tainted floor area into the patient’s opened surgical site. The potential risk of developing an infection is especially severe for individuals undergoing artificial heart valve implant surgery or joint replacement surgeries including knee and hip replacements.

The Inventor Speaks Out

Many patients have developed serious life-threatening infections after hip and knee replacement surgeries from using temperature management systems developed and sold by 3M Bair Hugger. Many of these individuals have filed lawsuits against the manufacturer of the device claiming negligence of its potential risks and safety hazards.

These warming devices are used during surgical procedures as a way to regulate body temperature. Currently, more than 50,000 warming systems sold by the device manufacturer are used in nationwide hospitals and have warmed millions of patients since the products were first brought to the medical marketplace.

Many personal injury attorneys, including Rosenfeld Injury Lawyers LLC, have claimed that the forced air warming blankets have design defects that cause a disruption of laminar flow during surgeries in operating rooms nationwide. The defects allow bacteria and other dangerous contaminants to transfer from the floor and enter the patient’s surgical site. The defect increases the potential risks of knee and hip implant patients to develop a life-threatening joint infection after surgery.

Zimmer is the latest manufacturer of hip replacement devices to issue a recall of its products due to the risk of severe complications and health concerns. The M/L Taper Hip Prosthesis with Kinectiv Technology was designed to be a versatile option for use in minimally invasive surgical procedures.

Zimmer’s recall was the result of discovery that the products were linked to unhealthy levels of cobalt in the blood, resulting in metal toxicity and conditions such as metalosis. The recall was one of three Class One recalls mandated by the FDA affecting Zimmer, HeartWare and Maquet Holdings.

Metal Toxicity is a Common Concern for those Receiving Hip Replacements

Power morcellator manufacturers and practitioners performing hysterectomies and other uterine procedures with the devices have come under fire following the discovery of a strong link between power morcellation and the spread of cancerous tissue to the uterus. The son of a woman who died from uterine cancer not long after undergoing a procedure which implemented the use of a power morcellator is seeking damages from multiple parties he alleges failed to warning his mother of the risks associated with the elective procedure and that had she underwent a more traditional procedure, she would still be alive today.

The lawsuit was filed on April 10, 2015 and is being heard by the United States District Court for the District of South Carolina.

Storz Morcellator Cited as Responsible for Spread of Cancer

Portions of the Zimmer Persona total knee replacement system is being recalled by its manufacturer. In February 2015, Zimmer, a leading orthopedic company, notified customers of its Class 2 FDA recall. The knee replacement system by Zimmer was the primary driver in increased sales for the company in 2014.

The recall affects more than 11,500 patients worldwide. The move by Zimmer and the FDA is expected to produce a negative profit outcome for the company.

The orthopedic company’s Persona Trabecular Metal Tibia Plate is being recalled because of increasing “complaints of radiolucent lines and loosening.” Apparently, the unit’s design creates an ineffective “seat for the plate” that can produce poor patient outcomes because it can generate significant knee pain.

In February 2015, a recall was issued for the Johnson & Johnson DePuy Synthes orthopedic tool that inserts titanium elastic nails to secure broken bones. The recall affects 1500 inserters that have been distributed across the United States since it first became available in the medical marketplace.

The Class II issued warning indicates that the orthopedic tool is prone to significant mechanical failure that can occur during surgery. Failures include breakage of the tool’s crossbar or main shaft along with the inserter becoming jammed during use.

The DePuy Synthes inserters are a functional tool used in various surgeries to repair long bone fractures. The tool inserts nails in the lower extremities of children or small-stature adults and can also be used for upper extremity repairs in adult patients. Surgeons also use the device to repair tarsal and carpal bones and other small long bone fractures.

C.R Bard Inc. settled over 500 lawsuits this month for a sum of over $21 million— or $43,000 per case. The lawsuits claimed that Bard’s transvaginal mesh products caused bodily harm to the women implanted with them for the treatment of pelvic organ prolapse and stress urinary incontinence.

These cases only signal the beginning, however, as Bard faces over 12,400 lawsuits and is one of numerous manufacturers targeted in similar lawsuits. Other manufacturers of transvaginal mesh devices known to cause severe complications include Johnson & Johnson and Boston Scientific Corp.

A Sign of Things to Come for Other Vaginal Mesh Patients

The Food and Drug Administration has classified the recently recalled guidewires manufactured by Minneapolis-based Medtronic, Inc. as potentially fatal. These guidewires are used in heart procedures.

The recall of the ATTAIN HYBRID wires and Interventional Wires began in October. This is when Medtronic started the recall after having received complaints from four different patients. One of the patients sustained injury because of these faulty guidewires.

One of the most recent recalls of the Stryker line of products is the ShapeMatch Cutting Guides. In recent years, a whole host of products have been recalled from the Stryker line. These products range from hip implants to the most recent cutting guides that assist surgeons in operations.

The ShapeMatch Cutting Guides can be used once and are disposable guides that help surgeons mark a bone before a knee replacement operation.A surgeon can follow the guide to position the components involved in a total knee replacement. The surgeon uses this guide based on an individual assessment of images that are taken of the individual’s knee.

Distribution of the ShapeMatch Cutting Guides