The Never-Ending Breast Implant Scandal: FDA Updates New Review

Doctors have been performing “breast enlargement surgery” since the 1950s. One of the earliest implants involved a foam sponge covered by polyethylene. It lost favor pretty quickly because it could lead to contraction and infection. Not long after, some plastic surgeons began injecting liquid silicone directly into women’s breasts. These procedures became the first breast implant scandal. The FDA has recently issued new warnings. They came too late for some women. On February 6, 2025 the agency updated its review of “breast implant illness” (BII).

FDA’s Report on Breast Implant Illness

Here is what the February 6, 2025 report offers about BII:

“These symptoms include, but are not limited to, fatigue, problems with memory or concentration (“brain fog”), joint and muscle pain, hair loss, weight changes, anxiety, and depression. The appearance of such symptoms has been reported with all types of breast implants regardless of filling, shape or surface characteristic, and the symptoms appear anywhere from right after implantation to years later.

“Although some patients report improvement or resolution of symptoms following removal of the implants, the cause of the symptoms and the degree to which they may be related to the implants are unclear at the current time.”

A reader describes the above situation:

Q. In 2009, Allergan was running a long-term study on silicone breast implants. I had always wanted a more feminine body like the girls in the magazines, so I joined and got implants. They never followed up with me, other than send me annual surveys to fill out.

Within a year, I ended up with mystery illnesses, including full-body itchy rashes and sores that didn’t heal, memory loss, major weight loss, constant diarrhea, abdominal pain and blurry vision. None of the many doctors I saw could tell me what was causing this.

The implants were removed in 2020. My symptoms have improved, but I am still not completely healthy. It makes me sad and angry that doctors I trusted did not inform me about the risks.

A. The safety of breast implants has been controversial for decades. The FDA recently issued an update on “breast implant illness.” Although the diagnosis is not official, the agency notes that many women experience fatigue, brain fog, hair loss, joint or muscle pain, rash, weight changes, anxiety and depression associated with implants.

About 40 percent of the reports note that the implant was removed, with many patients experiencing some improvement of symptoms after that. Some, however, “noted either no improvement or worsening of symptoms.”

What Happens When Implants Leak?

A reader recently shared this story:

“I had silicone breast implants for 23 years before the left side ruptured and spilled 100 grams of silicone into my body. I was not told that they would ever need to be replaced.

“I had many symptoms. My body hurt to sit in the car. I had so little energy.

“I felt better after explant and reimplantation with saline seven years ago, but now the symptoms are returning, and both breasts are painful. I now read that even saline implants can be problematic because the shell is made of silicone.

“I wish I had never gotten them to begin with. I plan on going natural. Then maybe I can enjoy this last chapter of life as a healthy, sexy 65-year-old!”

The FDA has a name for your condition: “breast implant illness.” The agency notes that:

“Over the past several years, the FDA has received new information pertaining to risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and systemic symptoms commonly referred to as breast implant illness (BII) that some patients attribute to their implants, which can include fatigue, “brain fog,” muscle or joint pain and rash.” (FDA’s Final Guidance for Labeling Recommendations for Breast Implants, Sept. 28, 2020).

Sadly, the FDA doesn’t actually come out and declare these symptoms are caused by breast implants. Instead, the agency says some patients “attribute” their symptoms to implants.  It took the agency more than 50 years to issue meaningful warnings about breast implants.

“Cleopatra’s Needle”

Dow Corning created “medical-grade” silicone in 1960. A refined product called Dow Corning 360 was sold under the brand name Dermagen. It was intended for burn patients.

But some physicians injected this liquid silicone directly into women’s breasts (Canadian Journal of Plastic Surgery, Fall, 2009):

“In the entertainment business, these silicone injections were referred to as ‘Cleopatra’s Needle’. It has been estimated that in Las Vegas in the 1960s, two physicians, alone, used silicone to inject the breasts of over 10,000 women over a 10-year period.”

The consequences of injecting liquid silicone into the breast were disastrous. Women reported painful and disfigured breasts caused by “…inflammation, foreign body reaction, and granuloma formation…” (Journal of Cutaneous and Aesthetic Surgery, July-Sept. 2012).  Granulomas show up as painful lumps, bumps or plaques.

The FDA Never Approved Liquid Silicone Injections:

Although the FDA never approved the use of liquid silicone injections for cosmetic purposes, tens of thousands of patients received such injections. The agency issued press releases in 1992 advising doctors not to inject silicone.

But the New York Times (Feb. 2, 1992) noted that:

“Despite warnings from the Food and Drug Administration that the practice is illegal, scores of doctors are continuing to inject silicone directly into the bodies of women, most often to puff up parts of the face or to smooth wrinkles, agency officials say.

“Sometimes the results were catastrophic. Some women’s faces became lumpy and ulcerated, and their features became distorted. In other cases, sores erupted on breast tissue, and breasts had to be removed. Sticky silicone lumps that have migrated can cause inflammation and are sometimes impossible to remove because they adhere like glue to body tissues.”

The Ongoing Breast Implant Scandal:

Although the FDA never officially approved liquid silicone injections, it did allow silicone gel implants. The first breast “augmentation mammoplasty” was done in 1962. Throughout the 1970s and 1980s there were a number of silicone gel implants created. Because of shell rupture and silicone leakage, manufacturers created a variety of “improvements.”

The covering of the silicone-gel sac was modified numerous times over the decades. There were third, fourth and fifth generation models. Some had thicker coverings that weren’t supposed to leak. Other implants had shells that enclosed both saline and silicone.

It took until 1988 for the FDA to require evidence that silicone gel implants were safe and effective. Four years later the agency determined that there wasn’t adequate information to determine that silicone-gel breast implants were safe and effective. Ooops!

The Breast Implant Scandal Continues:

Every year in the US about 400,000 women receive breast implants. It remains a very popular cosmetic surgery. But there is a dark side to these procedures. The breast implant scandal has not disappeared.

Over the course of the last few decades, tens of thousands of women have complained that their breast implants were making them sick. There’s even a name for this condition: “breast implant illness.” Many women reported debilitating fatigue. Others complained of joint pain, cognitive impairment, weakness, muscle pain and other autoimmune reactions. Many doctors and implant manufacturers discounted the complaints.

You might think that after the liquid silicone scandal during the 1990s the FDA would have been much more vigilant. It took until a few years ago for the FDA to reevaluate silicone and saline breast implants.

In March of 2019, the FDA held a conference to consider the safety of breast implants. Although doctors and manufacturers had dismissed complaints about complications, the agency decided to reexamine the data.

A Reader Makes the Breast Implant Scandal Personal:

“My daughter’s best friend had mysterious symptoms that were very difficult to diagnose. She was pale and suffered chronic migraines, nausea and occasional vision loss (probably from the migraines).

“She lost so much hair she needed to wear wigs, had trouble keeping food down and had joint and bone weakness. In addition, she had cognitive problems, as she was forgetting things and getting lost in mid-conversation.

“Eventually, her doctors decided that the problem was her 20-year-old breast implants, which were filled with saline. She had them removed, and the surgeons discovered that the seams of the implants had leaked silicone into her system. Moreover, the saline was nasty and contaminated with mold. Once the implants were removed, she immediately began to improve.

“Many doctors don’t like to admit that this is a thing, but it is. Meanwhile insurance will often refuse to pay because breast implants are considered ‘cosmetic.’”

The Breast Implant Scandal and the FDA:

The FDA issued labeling recommendations for breast implants (Sept. 28, 2020). The agency acknowledges that it has received new information about adverse reactions.

The FDA now recommends that women be informed of symptoms related to “breast implant illness” (BII). The agency also warns about cancer because there have been cases of lymphoma associated with breast implants.

In its document, “Risks and Complications of Breast Implants,” the FDA notes the following additional problems with breast implants:

• Implant complications, such as breast pain and changes in nipple and breast sensation
• Additional surgeries, with or without removal of the device (also see Implant Removal Options)
• Capsular contracture, scar tissue (capsule) that forms around the implant and squeezes the implant
• Rupture and deflation
• Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma (cancer of the immune system)
• Connective tissue disease, breast cancer, and reproductive problems
• Systemic symptoms
• Breastfeeding
• Effects on children

The FDA goes into more detail about lymphoma:

“In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. An individual’s risk of developing BIA-ALCL is considered to be low; however, this cancer is serious and can lead to death, especially if not treated promptly. In most patients, it is treated successfully with surgery to remove the implant and surrounding scar tissue, but some patients may require chemotherapy and radiation therapy.”

We wrote about the association between breast implants and cancer over seven years ago at this link:

Are Breast Implants Linked to Rare Cancer?
Dutch scientists have uncovered a link between breast implants and a rare cancer, anaplastic large-cell lymphoma of the breast. This deserves further scrutiny.

What took the FDA so long to publicize this connection?

The 50+ Year Breast Implant Scandal:

Remember when the first breast implant was performed? It was 1962. It took the FDA until September 28, 2020, to acknowledge that there were significant risks associated with silicone and saline breast implants. That’s more than 58 years.

If that is not a breast implant scandal, we don’t know what is. Sadly, it seems to have gone unnoticed. That’s because the coronavirus pandemic has captured health headlines for months. We hope that the new FDA labeling recommendations will force the manufacturers of breast implants and the doctors who perform these procedures to be more transparent about their products and procedures.

One last disappointment from the FDA:

“…BII is not recognized as a formal medical diagnosis and there are no specific tests or recognized criteria to define or characterize it.”

Please share your thoughts in the comment section below.