Dangerous Medical Device Recalled

Doctors at Hoag Hospital in Newport Beach removed a tumor from Laurie Kelly’s breast in June 2010. Six months later, it was discovered that during the tumor removal, the doctors had left Tungsten particles in her breasts.

Laurie Kelly’s surgery was the first of its kind at Hoag Hospital, the surgery involving both a lumpectomy and radiation treatment. With Xoft’s Axxent radiations system, doctors delivered electron radiation treatment before closing the incision. To protect healthy organs and tissues from the radiation, doctors implanted a shield, known as FlexiShield, into the body before performing the radiation treatment. The radiation treatment, known as Intraoperative Radiation Therapy (IORT), took less than 20 minutes unlike standard radiation treatments, which take six weeks.

Dr. Melvin Silverstein, the medical director of Hoag Breast Care Center, had informed Kelly that she was a candidate for the IORT. Kelly researched IORT, and received the impression that it was nearly finished undergoing a 10-year international clinical trial. Kelly did not realize, however, that the device the doctors would use on her was in fact made by the rival company of the company undergoing the clinical trial.

Trusting the doctors and the reputation of the treatment, Kelly agreed to go forward with the procedure.

When Kelly returned to the Hospital six months later for a standard follow-up mammogram, doctors informed her that there were tiny particles on the tissue of her left breast. They performed a biopsy on her breast and determined that the particles that had spread radially over 9 cm.

Renowned Mayo Clinic in Minnesota determined that the particles were tungsten particles that had shed from the Flexi Shield during the radiation treatment. The initial sample showed 207 micrograms of tungsten per gram of tissue. The second sample showed 67,264 micrograms of tungsten per gram of tissue.

Lab reports also showed that the Tungsten particles had migrated to other parts of her body. Passing through various pathways of her body, the particles eventually showed up in Kelly’s urine.

Although Xoft maintains that the particles would not harm women, some experts disagree. An Illinois-based lab asserts that long-term exposure to Tungsten may cause a hard-metal lung disease and lung cancer. Koren Mann, a Canadian Scientist, asserts that high doses of Tungsten may cause toxic effects to the immune system and may also damage DNA.

Fearing that the tungsten particles would lead to an obstruction in screening films used to detect a reoccurrence of cancer, Kelly underwent a mastectomy in April 2011. Later, in January 2012, she underwent reconstructive surgery.

After the reconstructive surgery, Kelly developed a staph infection. She has also experienced a variety of other health problems, including difficulty urinating and persistent fatigue. Believing that these problems are related to the Tungsten particles, Kelly has since filed a lawsuit against Hoag Hospital for the use of a pseudonym to convince her to agree to the surgery.

Hoag hospital defends that it had disclosed to its patients in writing that the radiation treatment was new and its safety had not been proven.

Since Xoft recalled the Axxent Flexi Shield in February 2011, tungsten particles have been found in the breasts of 29 former patients. Lawsuits have since been filed against Xoft.

The company has denied both negligence and liability. In defense to these lawsuits, Xoft has claimed that the injuries are the responsibility of either the hospitals performing the treatment or the patients themselves.

“Cases like [these] may cause the FDA to reevaluate their policies and procedures for authorizing treatment in an expedited manner,” said UCI Assistant Professor of Law, Shauhin Talesh.

The FDA cleared Xoft’s FlexiShield in 2009. FDA reviewers considered it substantially equivalent to other similar devices that have been cleared and did not express any concern that the shield was made from a different metal.

To better address the method of production clearance, the FDA is also currently negotiating with industry and Congress to raise its fees and funding. With increase in fees and funding, the FDA hopes to address problems currently impeding the fluidity of the production clearance, which include high turnovers, understaffing, and overworking employees.

This year, a bill has been introduced to adjust the eligibility requirement for production clearance. Under this bill, substantial equivalence to cleared devices will no longer suffice for the clearing of a new product.