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FDA warns about robotic devices for mastectomy and other cancer surgeries

The US Food and Drug Administration has issued a warning to patients and doctors considering the use of robotic surgery for mastectomy and other cancer-relat...

Posted: Mar 1, 2019 3:21 PM

The US Food and Drug Administration has issued a warning to patients and doctors considering the use of robotic surgery for mastectomy and other cancer-related surgeries, saying that robotic surgeries are not approved for the treatment or prevention of cancer.

"We are warning patients and providers that the use of robotically-assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency," Dr. Terri Cornelison, assistant director for the health of women in the FDA's Center for Devices and Radiological Health, said in a news release. "The survival benefits to patients when compared to traditional surgery have not been established."

Robotically assisted surgical devices allow surgeons to perform procedures through small cuts in a patient's body. The surgeon can then visualize the surgical site in three-dimensional high definition and control surgical instruments attached to mechanical arms via computer and software technology. Because it is minimally invasive, this approach may in turn reduce pain, blood loss, scarring, infection and recovery time after surgery, compared with traditional surgical procedures.

Robotic surgery has been widely adopted by surgeons for non-cancer-related surgeries, with their popularity crossing into the cancer surgery world, according to the report. The FDA has evaluated and approved robotically assisted surgical devices for use in certain types of procedures but not for mastectomy, saying that their safety and effectiveness have not been established.

The limited data available on the use of robotically assisted surgical devices in cancer surgery is not encouraging. One study published in the New England Journal of Medicine found that minimally invasive surgery, including robotic surgery, appeared to be associated with a lower rate of long-term survival compared with traditional abdominal surgery. Yet other researchers have reported no difference in long-term survival when these types of surgical procedures are compared.

While the FDA continues to review safety and efficacy data as it becomes available, it urges patients to discuss the risks, benefits and alternatives of all available treatment options with health-care providers. The agency also suggests that patients ask surgeons about their training, experience and outcomes with robotic surgeries.

As for physicians, the FDA urges them to take training for the specific robotically assisted surgical devices procedures they perform and openly discuss their level of experience and clinical outcomes with their patients.

Indiana Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 51079

Reported Deaths: 2756
CountyConfirmedDeaths
Marion12019693
Lake5588248
Elkhart353959
Allen2939134
St. Joseph210669
Hamilton1691101
Cass16449
Hendricks1454100
Johnson1340118
Porter82638
Tippecanoe7709
Vanderburgh7276
Clark69544
Madison67464
LaPorte61628
Howard59858
Bartholomew59745
Kosciusko5754
Marshall5449
Noble51328
LaGrange4849
Boone48244
Jackson4783
Delaware47152
Hancock46736
Shelby45425
Floyd40644
Morgan34231
Monroe34028
Grant31826
Dubois3046
Henry30018
Montgomery29720
Clinton2903
White27410
Dearborn25823
Decatur25632
Lawrence25225
Vigo2528
Warrick25029
Harrison21722
Greene19432
Miami1932
Jennings17912
Putnam1738
DeKalb1694
Scott1649
Wayne1546
Daviess15017
Perry14710
Orange13723
Steuben1362
Jasper1352
Ripley1307
Franklin1278
Gibson1202
Wabash1162
Carroll1142
Fayette1067
Whitley1066
Starke1043
Newton10010
Huntington942
Jefferson862
Wells821
Randolph794
Fulton731
Knox710
Jay700
Washington681
Pulaski661
Clay645
Rush613
Posey570
Spencer541
Owen521
Benton510
Sullivan501
Adams491
Brown431
Blackford402
Fountain352
Crawford330
Switzerland320
Tipton321
Parke270
Martin260
Ohio230
Vermillion200
Warren151
Union140
Pike110
Unassigned0193

Ohio Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 64214

Reported Deaths: 3036
CountyConfirmedDeaths
Franklin11724445
Cuyahoga8979393
Hamilton6781207
Lucas2952305
Marion274539
Montgomery244035
Summit2327209
Pickaway222241
Mahoning1928239
Butler182147
Columbiana137860
Stark1214114
Lorain112069
Trumbull104578
Warren97725
Clark80010
Delaware69815
Fairfield66717
Tuscarawas60410
Lake58923
Medina58232
Belmont56922
Licking56812
Miami50631
Portage49259
Wood48851
Clermont4737
Ashtabula44744
Geauga42543
Wayne37253
Richland3715
Allen35641
Greene3439
Mercer29910
Erie27122
Holmes2595
Darke25626
Huron2402
Madison2169
Ottawa17324
Sandusky16015
Washington14620
Ross1443
Coshocton1423
Athens1391
Crawford1385
Putnam13715
Hardin12312
Morrow1201
Auglaize1094
Jefferson1092
Muskingum1001
Union931
Preble901
Monroe8917
Hancock861
Lawrence830
Guernsey823
Clinton811
Hocking809
Williams762
Shelby744
Logan711
Ashland672
Carroll673
Fulton670
Scioto670
Wyandot635
Brown611
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Defiance533
Knox531
Champaign511
Highland501
Van Wert471
Perry441
Seneca412
Henry330
Paulding300
Jackson280
Pike280
Adams261
Vinton232
Gallia201
Noble140
Harrison131
Meigs130
Morgan110
Unassigned00
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