Study Suggests Women Have Higher Risk of Hip Implant Failure

A February 2013 study in JAMA shows that women have a higher risk of implant failure than men following total hip replacement. In a commentary, NRC President Diana Zuckerman stresses that long-term comparative effectiveness data would enable patients and their physicians to choose the hip devices and surgical techniques that are most likely to be successful for a longer period. Continue reading

New Review Shows FDA is Missing Crucial Safety Information on Breast Implants

January 5, 2011. A closer examination of the data regarding the FDA-approved breast implants made by Mentor and Allergan, however, indicates numerous errors and missing information in the FDA’s most recent research summary (published online in June 2011), as well as in the information the agency provided to their Advisory Panel that met to discuss breast implants in August 2011. Continue reading

Consumer group questions review of breast implants

Consumer safety advocates are questioning the Food and Drug Administration about incomplete and seemingly erroneous data used to support the safety of silicone breast implants in an agency review last year. The FDA concluded last summer that silicone-gel implants are basically safe as long as women understand they come with complications. Continue reading

FDA revokes Avastin approval for breast cancer. Decision leaves some devastated. Drug will remain available to treat other cancers.

Washington Post. November 19, 2011. “The science is clear: Breast cancer patients are more likely to be harmed than helped by Avastin,” said Diana Zuckerman, president of the National Research Center for Women & Families. “The risks of the drug are very substantial and can be fatal, killing patients long before they would otherwise die from the disease. FDA made a scientific decision, and it was absolutely the right decision.” Continue reading

Left to Their Own Devices

The Economist. September 10, 2011. Scandals, recalls, stingy customers, anxious regulators—any one of these would traumatise a chief executive. America’s industry for medical devices is suffering from all of them. Omar Ishrak, the new boss of Medtronic, the world’s biggest medical-technology company, recently described the problem succinctly to analysts: “There is a lot of work ahead of us.” Continue reading

FDA: Breast Implant Safety Studies Will Continue

Web MD. August 31, 2011. After two days of testimony on what the FDA should do about troubled long-term safety studies of silicone-gel breast implants, agency officials said the studies would continue. Public health research director of the National Research Center for Women & Families, Dana Casciotti, said the 27 page questionaires that are currently being used in the studies are too long and ineffective. In order for the studies to be successful, the questionaires need to be shortened. Continue reading

FDA eyes registry for breast implants problems

Reuters. August 31, 2011. U.S. health regulators said they would consider setting up a registry that tracks safety problems with breast implants, after too many patients dropped out of company-funded studies. NRC president Diana Zuckerman brings up the fact that Allergan has three times more patients participating than the other manufacturer of silicone breast implants Mentor, and that they needed to be held responsible. Continue reading

Report Could Sway FDA Device Review Process

Reuters. July 26, 2011. President of the National Research Center for Women & Families Diana Zuckerman is critical of the FDA for not moving sooner to make changes to the device approval process. She says “the whole process is illogical” and “in some kind of ideal world the FDA would have come out with these proposals and implemented them.” Continue reading

FDA backs decision to return silicone breast implants to market, despite frequent problems

Associated Press. June 22, 2011. President of the National Research Center for Women & Families, Diana Zuckerman, explains that missing data in the largest, most important studies on silicone gel breast implants weaken the quality of the studies and, therefore, the conclusions provide inadequate, useless information for consumers, health professionals, and the public. Continue reading

Most women with silicone breast implants need more surgery

MSNBC. June 22, 2011. Diana Zuckerman, president of the National Research Center for Women & Families, says the studies the FDA used to say silicone implants are safe are incomplete. In addition, Zuckerman claims women need to understand that when they get breast implants they may need removal or replacements for the rest of their lives. Continue reading

FDA seems to take light approach to Allergan and Lap-Band

LA Times. February 22, 2011. Dr. Diana Zuckerman, president of the National Research Center for Women & Families, criticizes the FDA’s recent approval of the lap-band surgery for the less obese; there is not sufficient evidence to ensure the safety of this procedure and the time to ask for better research is before you say yes. Continue reading

Medical Device Recalls and the FDA Approval Process

February 14, 2011. Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. Continue reading

New Study Shows that Most Medical Devices Recalled for Life-Threatening Problems Were Not Tested on Patients

EMBARGOED FOR RELEASE: 4 P.M. (EST), MONDAY, FEBRUARY 14, 2011. A new study released today finds that most medical devices recalled during the last five years for “serious health problems or death” were originally cleared (approved) by the Food and Drug Administration (FDA) using a less stringent process that does not require testing in patients. The study, released on-line prior to publication in the Archives of Internal Medicine, was co-authored by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. Continue reading