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Joint Replacement Device Recipients Face Risk of Potentially Fatal Syndrome

Written by CST Team | Category: Devices, News

Joint Replacement Device Recipients Face Risk of Potentially Fatal Syndrome

Bone cement is a material used in joint replacement procedures. The cement is used to adhere devices to the patient’s natural bone and prevent shifting or moving after placement. Bone cement is most commonly used in knee and hip replacement procedures and for years was considered a safe option for patients.

Unfortunately, some bone cements have failed to perform as expected, leading to complications and the need for follow-up procedures to correct the problem.

Despite claims to the contrary by manufacturers, the use of bone cement in joint replacement surgeries has led to serious medical complications, including fragmentation, device loosening, and a condition known as bone cement implantation syndrome.

What is Bone Cement Implantation Syndrome?

Bone cement implantation syndrome (BCIS) is a serious condition that causes cement, fat, and bone marrow to leak into a person’s bloodstream. BCIS can cause oxygen deficiency, low blood pressure, blood clots, pulmonary embolism, cardiac arrest, and a variety of other medical emergencies.

Researchers are not yet sure exactly what causes BCIS, but most believe it is linked to pressure that causes the cement to expand and heat up. That pressure also causes blood vessels to rupture, leading to marrow, fat, and cement leaking into the bloodstream. One study showed that an effort to reduce the pressure via a suction catheter reduced patients’ risk for developing BCIS.

Though BCIS can develop for anyone after undergoing a procedure using bone cement, the risk tends to be higher for patients who:

  • Are older
  • Have existing heart and lung function
  • Suffer from pulmonary hypertension
  • Have experienced multiple hip fractures
  • Suffer from osteoporosis
  • Are victims of bone cancer

The FDA identified a link between the use of bone cement and BCIS in 2002. Numerous patients suffered complications from BCIS in the decade and a half following the announcement and many of these cases were fatal. Still, manufacturers of bone cement continue to tout their products as safe and effective.

Alternatives to Bone Cement

It is possible to undergo a joint replacement procedure without bone cement.

Cement-less joint replacement, also called a press-fit prosthesis, uses specially textured devices that allow the bone to grow and adhere to it over time. Doctors typically discuss with patients in advance of surgery which option is best for them based on the patient’s physiology, the type of surgery being done, and the surgeon’s preference.

Bone cement does offer a few advantages for joint replacement recipients including:

  • Surgeons can affix prosthetic joint components to bones that have been affected by osteoporosis
  • Surgeons can utilize antibiotic material during the procedures to decrease the risk for infection
  • Bone cement is quick-drying and offers a level of confidence in the placement of the device within minutes

Unfortunately, for many patients, these advantages are outweighed by the complications associated with bone cement.

In addition to BCIS, patients must also be concerned that bone cement will break down, causing their device to loosen and require corrective surgery. Cement can also irritate the tissue surrounding the device. There are also instances in which patients are allergic to the cement – a problem that might not be identified until the device is in place.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

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