FDA Says It’s Too Soon To Ban Breast Implants Linked To Rare Cancer

March 28, 2019

Surgeon and his assistant performing cosmetic surgery in hospital operating room. Surgeon in mask wearing loupes during medical procedure. Breast augmentation, enlargement, enhancement

Government medical advisers are saying it’s too soon to ban a type of breast implant that has been linked to a rare form of cancer. The Food and Drug Administration recently said they need more information to understand how certain breast implants are causing cancer before they can make any restrictions on the products.

Breast implants have been subject to safety concerns for decades. But recent science shows these implants could potentially cause a rare form of lymphoma that grows in the scar tissue surrounding the breast.

The FDA hasn’t yet recommended any immediate restrictions on breast implants after a day of reviewing the latest research on the risks associated with the implants. However, the panel has thus far identified 450 cases of the rare cancer worldwide including 12 related deaths.

Nearly all 450 cases involve a type of textured breast implant, which is designed to minimize scar tissue and keep the implant from slipping. But the majority of the 19 FDA panelists say it’s too soon to remove the implants from the market.

“I think a knee jerk reaction of just pulling something without knowing what the replacement [product] will be might get us into more trouble,” said Karla Ballman, a biostatistician at New York’s Weill Cornell School of Medicine.

The risk of breast cancer is two times higher for individuals with one affected first-degree relative such as a parent, sibling, or child. This risk usually increases once the patient goes into menopause, which happens on average around age 51.

Compared to the 23,800 adults diagnosed with cancerous tumors of the brain or spinal cord every year, estimates of the frequency of this specific type of breast lymphoma range between one in every 3,000 people to one in every 30,000. The cancer grows slowly, but research shows it can be successfully treated by removing the breast implants.

But the issue isn’t just related to textured breast implants. The FDA has also received reports of breast lymphoma in those with smooth implants, which account for most of the U.S. market.

One panelist said a ban on textured breast implants would be an “extraordinary overreaction,” but their opinion wasn’t shared by the rest of the panel.

Consumer representatives on the panel stressed the risk to patients who get implants for reconstructive purposes after breast cancer surgery. If breast implants pose a cancer risk in those without a history of cancer, they could pose a greater risk for those with a history.

Approximately 400,000 people receive breast implants every year and 100,000 breast cancer patients receive them after surgery.

“I think that’s so much of a risk that they need to be taken off the market,” said FDA panelist Roberta Brummert.

The FDA plans to make recommendations on further studying and defining the risks and long-term chronic conditions of breast implants. This isn’t the first time government officials have intervened when it comes to cancer risks. The Surgeon General has warned that radon exposure is the second leading cause of lung cancer in the United States today. With this warning, officials hope to encourage homeowners to monitor the radon levels in their homes to prevent cancer before it starts. The FDA’s future recommendations could do a similar job of helping women avoid breast cancer by warning them of the effects of certain implants.

Patients who have received breast implants have made claims of muscle pain, chronic fatigue, rheumatoid arthritis, and other chronic ailments that could be associated with the implants.

Patients and health advocates are also calling for new warnings and restrictions on the use of breast implants so those who choose to undergo the surgery understand the risk.

“We need to know what we’re signing up for,” said Holly Davis, 60, of South Carolina. “It can’t be a surprise down the road.”

Davis reports that she experienced chronic pain, hair loss, rashes, and memory loss, after receiving silicone gel-filled implants in 2002 after undergoing a double mastectomy. After having her implants removed in 2017, her symptoms have resolved.

“Don’t ignore us,” said Davis. “We are real.”

Share This Post

Error, no group ID set! Check your syntax!

Leave a Reply

Your email address will not be published. Required fields are marked *