2 million faulty needles recalled by FDA

Needles can push bits of silicone from injection ports into patients' bodies

WASHINGTON - Federal health officials announced the recall of 2 million medical needles Tuesday because of a risk they can push bits of silicone into patients' bodies.

The Food and Drug Administration said Japanese manufacturer Nipro Medical Corp. has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009.

The needles are used to access injection ports, which are devices implanted beneath the skin of patients who require frequent injections. The ports connect to a vein and allow easy delivery of chemotherapy, antibiotics and other injectable drugs.

Huber needles are designed to be non-coring, or to penetrate an injected material without retaining any of it.

However, a monthslong FDA investigation found that the needles can dislodge bits of silicone from the ports, potentially pushing them into the patient's bloodstream. The problem can also damage the ports themselves, resulting in problems delivering drug therapy.

60 to 72 percent had design flaw
An inspection at Nipro's manufacturing plant in Japan found that 60 to 72 percent of the company's needles had the design problem, according to the FDA.

"The agency's laboratory work helped determine the coring problem, and we will continue to work with manufacturers to address coring issues as quickly and thoroughly as possible," said Dr. Jeffrey Shuren, FDA's director of medical devices.

Huber needles have been approved in the U.S. since 1984, according to the FDA.

FDA officials told reporters Tuesday they are working with 19 other manufacturers to determine if their needles have the same problem. The agency estimates 6 million Huber needles are sold in the U.S. each year.

According to FDA regulatory specialist Mary Brooks, there have been no reports of silicone shards in patients, though it may be difficult for doctors to identify the problem.

Tuesday's announcement was the second mass recall from Nipro Medical in less than a week. On Thursday the company recalled 15 lots of GlucoPro Insulin Syringes because of a defect that can cause the needles to detach.

FDA advised hospitals and doctors to stop using the Huber needles and return them to Los Angeles-based Exel International, which distributed the products in the U.S. The company can be reached at 1-800-940-3935.

A spokesman for Exel said the company hopes to wrap up the recall within 30 days.

The FDA made several recommendations to physicians when using other Huber needles, including: watching for signs of tissue or nerve damage in patients, which could be a sign of damage to an injection port. The agency also suggested throwing out the first syringe injected into a port, in an effort to discard any bits of silicone.

Acupuncture Effective in Easing Breast Cancer Treatment Symptoms

Aside from skin cancer, breast cancer is the most common cancer among American women, and the second leading cause of death in women. The American Cancer Society estimates that the chance of a woman getting breast cancer at some point during her life is slightly less than 1 in 8, and the chance of dying from breast cancer is about 1 in 35. However, as a result of early detection and vast improvements in treatment over the past two decades, breast cancer death rates have been decreasing. Today in America, there are more than 2.5 million survivors.

Although each person’s treatment will be slightly different, it most often involves some combination of surgery, radiation therapy and chemotherapy, followed by five years of hormone therapy and drugs like tamoxifen, which counters the effects of hormones. These treatments often cause uncomfortable and sometimes debilitating side effects, including decreased sexual desire and in younger women, early menopause—hot flashes, night sweats and mood swings. Venlafaxine, an antidepressant drug also known as Effexor, has been the treatment of choice for women undergoing breast cancer treatments, but it comes with its own set of side effects: dry mouth, decreased appetite, nausea and constipation. However, researchers say there is another option for these patients; one that works as well as drugs, without the side effects—acupuncture.

Previous studies have shown that acupuncture can reduce hot flashes in healthy postmenopausal women. So, researchers decided to find out if it could also benefit premenopausal women being treated for breast cancer. “We need something that’s accessible that doesn’t add adverse effects,” said Dr. Eleanor Walker, division director of breast services in the department of radiation oncology at Henry Ford Hospital in Detroit. For the study, 50 women with breast cancer were randomly chosen to receive either 12 weeks of acupuncture (twice a week for four weeks then once a week) or daily Effexor. They were followed for a year.

Initially, both groups experienced a similar reduction (about 50 percent) in hot flashes, depression and other menopausal symptoms as well as improvement in mental health. But two weeks after treatment stopped, hot flashes increased in the antidepressant group but remained minimal in the acupuncture group. It wasn’t until three months after the last treatment that hot flashes began to return for those receiving acupuncture. Additionally, about 25 percent of women receiving acupuncture reported better sex drive and many reported increased energy and clearer thinking. Adverse effects, including nausea, headache, difficulty sleeping and dizziness were reported by the antidepressant users, whereas no adverse effects were reported with acupuncture. “Acupuncture offers patients a safe, effective and durable treatment option for hot flashes, something that affects the majority of breast cancer survivors,” Walker said. “Compared to drug therapy, acupuncture has benefits, as opposed to more side effects.”

Janet Konefal, a licensed acupuncturist and assistant dean of complementary and integrative medicine at the University of Miami Miller School of Medicine, theorized that acupuncture operates as a balancing tool. “It is a regulator for the systems of the body. It doesn’t add or take anything—it simply increases activity or decreases activity depending upon the points used,” she explained. “In this situation, it helped regulate the endocrine system, thus helping to balance the activity of hormones, neurotransmitters, and other biochemical reactions that regulate the body.”

But other experts say it’s too early to take the findings too seriously. “It’s provocative but the problem is it’s a small number of patients and, having participated in research trials in vasomotor (hot flashes, night sweats, etc.) symptoms in women, it’s a field that has a large placebo effect,” said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge. “It needs to have a bigger trial.”

The World Health Organization (WHO) recommends acupuncture as an effective treatment for over 40 medical problems, including allergies, respiratory conditions, gastrointestinal disorders, gynecological problems, nervous conditions, and disorders of the eyes, nose and throat, and childhood illnesses, among others. Acupuncture has also been used in the treatment of alcoholism and substance abuse.

The study results are published online in the Journal of Oncology.