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FDA weighs cancer risk of fibroid removal devices

By WTOP Staff

MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) — Federal health advisers say there is little to no evidence that a popular technique for removing fibroids can be performed without the risk of spreading undetected cancers to other parts of the body.

The panel of Food and Drug Administration experts also said Friday that women who do undergo the procedure should sign a written consent form stating they understand the serious risks of laparoscopic power morcellation, in which electronic tools are used to grind tissue and remove it through a small incision in the abdomen.

Surgeons developed the technique as an alternative to traditional surgery, which requires a larger incision that often results in more bleeding and longer hospital stays. But the FDA convened a two-day meeting this week after concluding that the risk of accidentally spreading undetected cancer to other organs may be far more common than previously thought.

The agency asked its panel of obstetrics and gynecology experts to weigh in on potential methods for minimizing the risk, including using plastic specimen bags to catch bits of shredded tissue. Some surgeons already use that technique, but panelists said it is based on “intuition.”

“There’s no evidence that the bags or any containment devices prevent the outcome we are trying to prevent,” said Dr. Craig Shriver of the Walter Reed Medical Center.

The panel also discussed the difficulties of screening women for a rare form of uterine cancer, called leiomyosarcoma, ahead of the procedure. Imaging techniques are often unable to distinguish between the cancers and normal fibroids. And while there are some common risk factors — based on women’s age, race and family history — panelists said they are not reliable.

“It doesn’t sound like anyone has confidence that those will be able to predict the vast majority of leiomyosarcomas,” said Dr. Michael Diamond, of Georgia Regents University.

The FDA takes the opinions of its panelists into consideration when it makes regulatory decisions on medical devices and other treatments. The agency has not set a timeline for taking action on power morcellators.

Doctors have long acknowledged the risk of accidentally spreading undetected cancer with such electronic shredding tools. But in April the FDA said doctors should halt use of the devices for fibroid treatments after agency scientists calculated that the risk of cancer spread was greater than previously thought. The agency estimated as many as 1 in 350 women may have undetected uterine cancer that can be ruptured by the technique. Previous estimates put the rate closer to 1 in 7,000

Earlier in the day cancer patients and family members of deceased patients urged the FDA to ban the use of electronic surgical tools for fibroid removal.

“Would you permit your wife or sister to undergo a procedure that has a one in 351 chance of spreading cancer throughout the body?” Colleen Daley asked the FDA panel. Daley’s sister, Patricia Marie Daley, died in 2011 of leiomyosarcoma that spread to her lungs after undergoing treatment via power morcellation.

The FDA approved the first electronic morcellators in 1995 and about two dozen have been approved in U.S. since then. The devices were cleared through an abbreviated review process because they were deemed similar to manual surgical devices long on the market.

Fibroids are non-cancerous growths in the uterus that can cause severe pain, heavy bleeding, and bladder and bowel dysfunction, mostly among women in their late 30s and 40s. It’s unclear what causes the tumor-like growths — which can grow as large as cantaloupes — but they account for an estimated 240,000 of the 600,000 annual hysterectomies in the U.S. At least 50,000 U.S. women undergo hysterectomy using the power morcellation technique.

Hysterectomy is a key treatment because it is the only way to ensure that fibroids do not return. Myomectomy, surgery that removes fibroids while leaving the uterus intact, is recommended for women who still want to become pregnant.

Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Don’t Settle for Student Loans to Pay for Online Education

By WTOP Staff
Online college programs are becoming a more popular choice for prospective students, with one study finding that more than 6 million students enrolled in at least one online course in fall 2015. The popularity of these courses can be attributed in part to their flexibility with working adults' schedules, students' ability to progress more quickly through online programs and, oftentimes, cheaper tuition. [See 10 low-cost online bachelor's programs for out-of-state students.]Online degrees can be beneficial to many college students, but some studies have shown online learners complete their programs at lower rates than students at traditional brick-and-mortar campuses. Individuals with student loans but no degree comprise two-thirds of defaulted borrowers. Though these numbers are not encouraging, just like for traditional programs, there are ways to reduce how much you'll need to borrow for an online program to ensure you won't become one of these statistics. Don't just settle on borrowing student loans to cover the whole cost of your program and living expenses. Instead, start thinking about how to cut costs and cover your balance in different ways, such as the following. -- Grants and scholarships: Even though you are taking an online course, you can still apply and receive grants and scholarships. But your first step should be to complete the Free Application for Federal Student Aid, commonly referred to as the FAFSA, which will allow you to receive a Pell Grant if your expected family contribution is low enough. The EFC criteria and award amounts are adjusted annually, but the 2017-2018 academic year awards range from $606 to $5,920, which could significantly lower the amount you borrow annually. Your next step is to apply for scholarships. You can start by checking online scholarship search engines, such as the Salt Scholarship Search, College Board's BigFuture and Peterson's. But don't forget to take advantage of local organizations and your school's financial aid office. Both may offer scholarships that you can't find with a national scholarship search. [Review these 10 sites to kick off your scholarship search.]For instance, organizations like the Elks Club, Knights of Columbus or the Rotary Club typically offer scholarships annually to local students. Just because you're going to school online doesn't mean you're ineligible. Visit your local library for scholarship listings, and ask around town. You might be surprised how many local organizations offer scholarships. While these scholarships typically aren't large, every little bit counts. Each dollar you receive in a scholarship is a dollar you don't have to borrow and pay interest on. -- Work-study: Another option for online students may be work-study awards. Not all students enrolled in online programs are eligible, but students at some schools -- including, for example, SUNY Empire State College and Liberty University -- are. Work-study awards are not given upfront like scholarships and grants. In most cases, they are an offer to earn up to the awarded amount if you secure an eligible work-study job. While there is a misconception that all work-study jobs must be on campus, students can work for off-campus, nonprofit or public employers as long as the work is in the public's interest. You may be able to work for a for-profit employer if the job is relevant to your course of study. No matter who the outside employer is, it will need to have an established agreement with your college for you to receive work-study funds. Remember, to be eligible for federal financial aid, you must be enrolled and pursuing a degree or certificate. If you're not working toward a credential, Pell Grants and work-study won't be option, but you may still be able to take advantage of private scholarships -- just be sure to read the eligibility criteria carefully. [Explore what to know about financial aid in online programs.]-- Pay as you go: One of the great benefits to enrolling online is the flexible schedule, which can allow you to complete your college coursework around your responsibilities. But prospective students often overlook using their part- or full-time job earnings as an option for paying for college. Almost 80 percent of college students in 2015 worked at least part time while attending classes, according to the National Center for Education Statistics. By budgeting and thinking strategically about your college costs, you can likely reduce your dependence on student loans by paying a portion out of pocket. Many -- but not all -- online programs are less expensive than traditional programs and often have shorter payment periods. Six, eight or 10 weeks are common course durations. Because of the frequency of payments in an online setting, you may be well-placed to pay as you go and possibly avoid borrowing altogether. Attending college online and avoiding student loans may be challenging, but if you are willing to put in the effort, you can limit the amount you need to borrow. More from U.S. News Q&A: Understanding Student Loan Discharge Eligibility Student Loan Refinancing Isn't Right for All Borrowers
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