Matthew was a physically active individual who suffered a minor tear in his right bicep tendon his while throwing a football. Following surgery to repair the tear, Matthew’s condition worsened. Matthew’s surgeon had implanted a pain pump device to deliver pain medication directly into the shoulder joint for up to 72 hours following surgery, following a method that was instructed to surgeons by pain pump manufacturers.

However, the constant drip of anesthetic into the shoulder joint was found to wear down the cartilage in the shoulder joint, resulting in a painful and debilitating condition known as chondrolysis. In November 2009, as more cases of chondrolysis in shoulder joints surfaced, the Food and Drug Administration (FDA) issued a warning to health care professionals that it had never approved such use of pain pumps in shoulder surgeries.

Jurors awarded Beale $1.275 million in economic damages and $3 million in non-economic damages. His wife, Krista Beale, was awarded $1.2 million in loss of consortium damages.

Source: The Medical News

SOURCE: Pain Pumps › Oregon appeals court denies I-Flow request for retrial

Pain pumps

PAGCL is a painful and debilitating condition that occurs when the cartilage in the shoulder joint wears away, causing the bones to rub together. There is no cure for PAGCL. Some patients my require shoulder replacement surgery.

There are three medical device manufacturers at the crux of the shoulder pain pump controversy – Stryker Corporation, I-Flow Corporation, and DJO Incorporated. Stryker is a multinational, publicly traded corporation that sells the McKinley Medical LLP pain pump products in the U.S., Canada and Mexico. In 2006, the company reported net sales of almost $5.5 billion.

I-Flow’s family of products focuses on Regional Anesthesia, Intravenous (IV) Infusion Therapy, and Oncology Infusion Services. It’s acute pain management product line includes the ON-Q PainBuster Post-Op Pain Relief Sustem, The Soaker Catheter, and the C-bloc Continuous Nerve Block System. I-Flow has exclusive rights in the U.S. to distribute the On-Q PainBuster. In 2007, company recorded assets exceeding $81 million.

DJO is a global provider of solutions for musculosketal and vascular health that specializes in rehabilitation and regeneration products for the non-operative orthopedic, spine and vascular markets. The company manufactures and/or distributes the DonJoy Pain Control Device. In 2007, the company reported net assets of more than $173 million.

Allegations against the manufacturers include negligence, strict liability, warranty, and failure to warn physicians and patients of the risk of chondrolysis with use of the shoulder pain pumps. Those who have been injured by shoulder pain pumps are advised to seek legal counsel, as they may have a case against the manufacturer.

SOURCE: Pain Pumps › Three pain pump manufacturers at crux of controversy

Mathew McKeown

But during a game in October 2006, McKeown’s left shoulder was injured while trying to recover a fumble. Doctors implanted the catheter of a On-Q PainBuster pain pump manufactured by I-Flow into his shoulder joint. For up to 72 hours, medication gradually dripped into his shoulder and slowly began eating away at the cartilage.

But McKeown was tough. He rehabbed quickly and bulked up to 300 pounds. He lead the team in weightlifting statistics, bench pressing a maximum of 460 pounds. His chances at making to the NFL one day seemed promising.

Even as he worked out, he ignored the burning pain in his shoulder, refusing to admit to anyone how badly it hurt. And then he injured his shoulder again. Once again, he was put on an I-Flow pain pump that dripped medication into his shoulder joint. A follow up MRI revealed a horrible mess. The promising athlete’s shoulder cartilage had been worn down so badly that repairing it was impossible. McKeown’s hopes for a professional football career were ruined.

McKeown is now suing I-Flow, the manufacturer of the pain pump, after he and his doctor learned that a 2006 study had revealed that by inserting the pain pump’s catheter in McKeown’s shoulder joint instead of the muscle tissue, the medicine essentially destroyed his shoulder. The Food and Drug Administration (FDA) had granted approval to have the pain pump’s catheters inserted into the muscle tissue, but denied manufacturers’ request to instruct surgeons to place the catheters in the shoulder joint. As a result, countless patients have suffered similar fates as McKeown.

Source:
Cincinnati.com

SOURCE: Pain Pumps › Athlete’s hopes of playing pro ball dashed by shoulder pain pump

The On-Q PainBuster pain pump offers an alternative to traditional intravenous and oral painkillers, which can leave patients feeling groggy. The pain pump uses a small balloon that holds a local anesthetic that is fed through a thin antimicrobial catheter that is inserted into the surgical site. The device injects the pain relief medication directly to the surgical site on a continuous basis for up to 72 hours following surgery. Following surgery, the patient goes home with the implanted device and after two or three days, the patient gently pushes out the catheter and discards the device.

Doctors who have used the pain pumps for hysterectomies and C-sections say the device helps women get up and about faster than using more traditional pain meds.

The I-Flow On Q PainBuster pain pumps have been a popular choice for orthopedic surgeons performing knee and shoulder surgeries. The pain pumps are designed and intended to be used with anesthetics that are administered continuously over time.

However, in shoulder surgeries in particular, the medication delivered directly to the surgery site has caused serious and permanent damage to the cartilage of the shoulder joint. This narrowing of the joint space is known as chondrolysis, a condition in which the complete or nearly complete loss of cartilage in the shoulder joint. Chondrolysis is an irreversible disabling and extremely painful condition.

A recent study published by The American Journal of Sports Medicine identified these intra-articular pain pumps as the likely cause of chondrolysis in shoulders.

There do not appear to be any reported problems with pain pump use following C-sections and hysterectomies at this time.

SOURCE: Pain Pumps › Pain pumps used following C-sections, hysterectomies