7/31/2019 Week 29 Health

1/1

HealthDay Reporter

While thousands of Americansave benefited from hip replacements

ver the years, problems with metal-n-metal implants can lead to trou-les requiring surgery to replaceefective devices, experts say.

Specifically, experts say, tiny frag-ents of metal can shear off from

hese joints, causing chronic pain ornfection and raising levels of metalsn the bloodstream. Experts estimatehat more than 500,000 Americansave received a metal-on-metal hip

oint, mostly between 2003 and 2010.Worry over the failure rate of the

mplants, and the speed at which theyere initially approved for the U.S.arket, has led to a special two-day

ession, beginning Wednesday, by ex-erts at the U.S. Food and Drug Ad-inistration."Data from recent studies and from

DA's own review show some pa-ients experiencing complications, in-luding the need for additionalurgeries, which could be attributedo metal-on-metal hip implant de-ices," said FDA spokeswomanichelle Bolek.Since 1999, almost 17,000 prob-

ems with these devices have been re-orted to the FDA. Of these, morehan 12,000 were reported last yearlone.According to the agency, the prob-

lems with metal-on-metal implantsare about the same as those seen withpolyethylene and ceramic implants,except for the specific risks caused bythe metal itself.

But others say that when it comesto complications, metal-on-metal im-plants are in a class of their own.Writing earlier this month in the NewEngland Journal of Medicine, Dr.Joshua Rising of the Pew CharitableTrusts, and colleagues said that"there is now compelling evidencethat these implants fail at a higherrate than hip prostheses made ofother materials; indeed, one type of

metal-on-metal hip has a failure rateof nearly 50 percent at 6 years."

Responding to these concerns, theFDA panel is considering the risksand benefits of metal-on-metal im-plants and what might be needed tomonitor the health of patients whohave them.

Of the estimated 400,000 hip re-placements done in the United Stateseach year, 27 percent involve metal-on-metal devices, according to theFDA.

Critics, including an independentpanel of experts at the Institute ofMedicine, have noted that metal-on-metal implants may have been ap-

proved too quickly under the FDA's"fast-track" program for medical de-

vices.Responding to concerns, in May

2011 the FDA ordered manufacturersto carry out "post-market" studies,tracking the safety of metal-on-metalhip implants in recipients. But in theNEJM article, Rising and colleaguesnoted that most of these studies haveyet to begin and their first results willtake years to arrive.

The FDA's Bolek made it clear thatthe advisory panel meeting is not aregulatory meeting and is not in-tended to look at the process thatbrought the devices to the market, orto deal with any planned or currentpost-marketing studies.

Metal-on-metal devices have al-ready been recalled twice. In 2008, adevice from manufacturer Zimmer,the Durom Acetabular Component,was recalled because instructionswere not clear.

And in 2010, a device from DePuyOrthopaedics Inc. was recalled be-cause more patients than expectedhad to have new surgeries, accordingto the FDA.

Earlier this month, a device calledthe R3 Acetabular System fromSmith & Nephew was taken off themarket because the company said itwas "not satisfied with the clinical re-sults of this component."

In Europe these concerns have ledto calls to ban metal-on-metal hip re-placement devices. Writing in Marchin the journal The Lancet, British re-searchers concluded that "metal-on-metal stemmed articulations givepoor implant survival compared withother options and should not be im-planted." Metal-on-metal implantshad a five-year failure rate of morethan 6 percent, three times higherthat seen with ceramic or plastic

joints.Banning metal-on-metal joints

isn't an option being considered bythe FDA panel at this time.

"During the panel meeting, FDAwill discuss failure rates and modesfor these devices, as well as any localand systemic complications that couldresult from metal debris and metalion levels in the bloodstream from thedevice," Bolek said.

The panel will also discuss metalion testing and soft tissue imaging,tools that can potentially be used inthe clinical management of patientswho have these devices, Bolek said.

"We will also review specific riskfactors for specific patient popula-tions and considerations for post-im-plant follow-up," she added.

Mindy Tinsley is a spokeswomanfor metal implant maker DePuy Or-thopaedics Inc., which is owned byJohnson & Johnson. She said that"DePuy believes that no single bear-ing surface meets the needs of all pa-tients, and metal-on-metal implantsprovide the potential benefit of

greater function and a lower risk ofdislocation for some patients."

Tinsley also said that all metal-on-metal implants are not alike and they

should not be grouped together ifproblems arise.

One orthopedic expert agreed. Dr.Joshua Jacobs, first vice president ofthe American Academy of Or-thopaedic Surgeons, said that "metal-on-metal devices are not all the same.

You have to go down to the individualproduct to fully understand the re-sult. When you lump metal-on-metaltogether, you miss a lot of importantdifferences."

According to Jacobs, who is chair-man of the department of orthopaedicsurgery at Rush University MedicalCenter in Chicago, the advantages ofmetal-on-metal implants are that

there is typically less wear on thejoint, leading to less loosening andless bone loss over time.

In addition, he said, metal allowsfor a thinner, larger socket and head,which makes it less likely the hip willdislocate after surgery, which is acommon failure of other types of hipreplacement.

Still, given the problems with thesedevices, Jacobs agrees that patientsneed to be monitored.

"We are trying to learn the optimalway of monitoring patients withmetal-on-metal implants, so we canunderstand when it is appropriate tointervene," he said. "Right now we are

amassing clinical data to understandthat better."

More information:For more on hip replacement, visit

the American Academy of Or-thopaedic Surgeons.

SOURCES: Michelle Bolek,spokeswoman, U.S. Food and Drug

Administration; Mindy Tinsley,spokeswoman, DePuy OrthopaedicsInc., Warsaw, Ind.; Joshua Jacobs,M.D., professor and chairman, De-partment of Orthopaedic Surgery,Rush University Medical Center,Chicago, and first vice president,

American Academy of OrthopaedicSurgeons; New England Journal of

Medicine, June 20, 2012Last Updated: June 27, 2012Copyright 2012 HealthDay. All

rights reserved.

YOUR GOOD HEALTH

2 Rubin Dr., Rushville Open Mon.-Sat.

Currently accepting new Medical and Dental patients.

Accepting all insurances, including Medicaid &Medicare. Sliding fee discounts available to

qualifying patients with no, or limited, insurance.

Expanded Hours for your convenience:Mon-Thurs 7:30am-7pm; Fri 7:30am-5pm; Sat. 8am-12pmCall 585-554-4400 to schedule an appointment.

Dr. Kim Healy

134 Lake Street Penn Yan, NY 14527

315-536-3700

Serving All Ages of Individuals & Families Since 1987Specializing In Healing Work For:

Abuse & Trauma Life Transitions Grief & LossUnique Sand Tray Therapy Experience Available

to All ClientsBy Appointment Only

215 Main St., Suites 3 & 5 Edith Kerby Mann, L.C.S.W.Penn Yan Counselor(315) 536-7329 Sand Tray Therapist

Seneca Lake Terrace3670 PreEmption Rd., Geneva

315-789-4162We offer beautifully designed privateapartments in a neighborhood setting.

24 hour security Deliciously prepared restaurant style meals served

All housekeeping, laundry and linen provided Dynamic activities program

Beauty Salon, Ice Cream Parlor, Chapel Outdoor Gardens and enclosed patios

Caregivers availableCome see why so many have chosen

Seneca LakeTerrace

Visit us on the Internet atwww.senecalaketerrace.com

PENN YAN

COMMUNITYHEALTH

Yates FamilyPlanning is now

SAME location, SAME providers,

MORE services!

ACCEPTING

NEW PATIENTS Still offering complete family

planning and reproductive services

Now offering FULL medicalservices as well

Accepting Medicaid, Child HealthPlus and most other insurances

Generous sliding fee scalefor those without insurance.

Full dental services COMING SOON!

160 Main Street

Penn Yan(315) 536-2752

2-day meeting will assess how patients with the devices should be monitored

Wednesday, July 18, 2012 Chronicle-Express.com The Chronicle-ExpressB9