For 15 years, Dr. Jeffrey E. Shuren was the federal official charged with ensuring the safety of a vast array of medical devices including artificial knees, breast implants and Covid tests.
When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.
But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.
One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.
Theranos records for 2015 and 2016 show a $1.6 million payment to Arnold & Porter for legal services.
Breast implants tied to cancer
In the spring of 2019, the drug and device maker Allergan was under scrutiny at the F.D.A.: Women were developing a rare form of lymphoma linked to the company’s textured breast implants, which had been recalled by more than 30 countries.
In May, Dr. Shuren and another F.D.A. official announced that the implants would not be recalled. In July, Dr. Shuren and the other official reversed course and said that they would urge a recall, citing additional reports of injuries and deaths related to the lymphoma.
Debates over warnings for LASIK
Paula Cofer has waited 15 years for the F.D.A. to strengthen the warnings given to LASIK vision correction surgery patients. About 700,000 people get the procedure each year; the agency regulates the lasers used in the surgery.
Ms. Cofer had suffered vision problems after undergoing LASIK herself. She served as the patient representative on an F.D.A. panel that held a hearing in 2008 about the procedure’s risks, which include dry eye, distorted vision and, in some cases, pain.
In 2016, the F.D.A.-sponsored study of LASIK found that 45 percent of people who had no visual symptoms before the procedure reported new issues afterward, particularly seeing halos or star bursts. Nearly 4 percent of people reported “very” or “extremely” bothersome symptoms after six months, including double vision.
Years passed until the summer of 2022, when Dr. Shuren announced that the F.D.A. was proposing to require eye surgeons to warn patients about the risks of LASIK surgery.
Ms. Cofer said she had felt devastated watching the agency stand by as LASIK patients were harmed. She called for Dr. Shuren to resign years ago.
“Their job is to protect the public health,” she said. “They’re doing the opposite. Anybody who doesn’t see that is not looking.”
