37931307 - plastic surgeon woman holding different size silicon breast implants in surgery room interior

The recent FDA confirmation of the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare version of non-Hodgkins lymph cancer, is the latest volley from the arsenal of manufacturer-health provider-regulatory agency collusion. Unwitting females around the world continue to sign up for breast enlargement and reconstruction in record numbers despite the checkered history of the procedure. 

Here’s what we know

As of February of this year, the FDA database for BIA-ALCL includes 359 cases including 9 deaths, joining 46 cases in Australia, with 3 confirmed deaths. Spotty and variable reporting practices and the absence of worldwide implant sales data make global statistics unreliable, so it’s safe to assume the problem occurs more frequently than disclosed. The risk of cancer and death occur with all versions of implants, whether saline or silicone, smooth or textured.

Most cases have been reported for silicone implants, which may reflect the fact that silicone implants are far and away preferred over saline. In 2015, U.S. surgeons performed 255,060 silicone implant surgeries versus only 36,140 for saline implants. Textured implants are implicated more often than the smooth variety, and a low-grade bacterial infection associated with the implant is present in all cancer cases. The most common BIA-ALCL finding is seroma, a fluid collection that develops on average, ten years after the implant is placed. Swelling, hardness, tenderness and/or redness near the implant are other telltale signs. If the implant and surrounding tissue are removed early enough in the course of cancer, no further treatment is necessary.

In cases that spread through the lymph system, and to other organs, radiation and/or chemotherapy would be advised. The FDA does not recommend any change in the routine medical care and follow-up of women with breast implants, nor does it recommend implant removal in the absence of symptoms or physical changes. For silicone implants, screening for rupture is recommended beginning three years after surgery and every two years thereafter.

FDA “news” of the implant-cancer link isn’t news at all.

In fact, worrisome information surfaced twenty-one years ago. BIA-ALCL was first reported in 1996, red flagged by the FDA as worthy of further study in 2011, recognized by the World Health Organization as a distinct entity in 2016, and finally, in 2017, granted an FDA warning. The “news” is just the latest installment in the undistinguished legacy of breast implantation.

The story of modern breast implants began in 1961 when Texas doctor Frank Gerow squeezed a plastic transfusion bag full of blood and commented that it felt quite like a female breast. In short order, with the support of Dow Corning, that aha moment led to a test silicone implant surgery on Esmerelda, a dog who chewed open her stitches, forcing the removal of the implants two weeks after they were placed. With a total animal experience of one, and absolutely no long-term follow-up, the operation was declared a success and Dr. Gerow announced:

The procedure was as “harmless as water.”

Next, he and a colleague convinced a woman to undergo the operation, in return for which they performed a cosmetic procedure she really wanted: having her prominent ears pinned back. The team continued performing silicone breast implants, through which they learned the other complications include infection, swelling from clotted blood, and capsular contracture, the immune system’s reaction to the presence of a foreign body, walling it off with fibrous scar tissue which deforms, hardens and shrinks the implant and the host breast. If these reactions sound familiar, that’s because they remain common surgical risks to this day.

1977 – FDA deems implants a Class 2 medical device

Breast implant surgery continued, unregulated until 1976, when the FDA deemed implants a class 2 medical device, placing them in the same, relatively harmless category as surgical drapes, powered wheelchairs, and air purifiers. Thereafter, with widening use, a steady stream of reports of adverse health effects and emerging safety concerns appeared in the medical literature and in the courts.

1988 – FDA reassigns implants to Class 3 medical device

Finally, in 1988, twelve years after the initial FDA classification and twenty-six years after the first human surgery for silicone implants, indisputable data convinced FDA to reassign them to medical device class 3, the highest risk category, which includes implantable pacemakers and external cardiac defibrillators. By definition, class 3 devices support life, or substantially prevent the impairment of human health, or pose a potential, unreasonable risk of illness or injury. Breast implants clearly meet the latter condition.

Class 3 status mandates that manufacturers submit safety and effectiveness data for the device, but, despite an FDA panel concluding this was never done, they voted unanimously to allow the implants to continue to be marketed. Almost four years after that, at the end of 1991, the FDA concluded that silicone implant manufacturers still had not provided safety and efficacy data, yet again, unanimously voted to allow marketing of the implants.

Woman awarded 7.3 million dollar lawsuit

It gets worse. One month after the 1991 FDA ruling allowing a high-risk medical device with no scientific safety and effectiveness data to be implanted in women, Mariann Hopkins, age 48, was awarded 7.3 million dollars in her lawsuit against Dow Corning. After surviving breast cancer and double mastectomies, she developed mixed connective tissue disease, an autoimmune disorder the jury related to repeated ruptured implants seeding silicone throughout her body. Confidential Dow Corning communications released at trial showed that at the same time the company reassured the public about implant safety, its scientists had no long term data to actually support the claims. The Hopkins lawsuit was one of many, and in January 1992, one month after her jury award, the FDA announced a voluntary moratorium on silicone implants, followed in another month, February 1992, by a ban which took them off the market pending further review.

The virtually banned silicone implant (front) and the saline substitute.

In April of 1992, the FDA declared that no manufacturer of silicone implants had submitted enough information to warrant approval based on demonstrated safety and effectiveness, and advised they should only be used for breast reconstruction or replacement of existing implants. With 19,000 implant-related lawsuits pending, Dow Corning filed for bankruptcy in 1995. In 2000, the FDA approved saline implants for reconstruction at any age, and for augmentation at age 18 and up. In 2006, fourteen years after they were removed from the market, silicone implants were re-approved for augmentation in women ages 22 and older, and for reconstruction at all ages. Five years later, in 2011, the FDA issued a Safety Communication indicating that based on a review of the scientific literature, BIA-ALCL is a small but real cancer risk to implant users. Since then, three more silicone implant devices have been FDA approved.

History repeats itself

Shoddy regulatory oversight of female health is not new. U.S. physicians prescribed DES to pregnant women starting in 1938, a full nine years before it was granted FDA approval to prevent miscarriage. Despite a rigorous scientific study published in 1953 showing DES to be ineffective, and a 1971 report of rare vaginal cancer in girls whose moms had taken DES, the FDA did not ban it. DES continued to be prescribed until the 1980s, finally having its FDA approval withdrawn in 2000. In 2011, the same year the FDA conceded there is a lymph cancer risk associated with breast implants, it acknowledged the DES tragedy but refused to apologize for it.

Then there’s Premarin, produced from horse urine, a form of menopausal hormone replacement therapy first marketed in 1941, in use for thirty-one years before its manufacturer submitted effectiveness data to the FDA. In 1997, the widely used drug became a blockbuster, reaching 1 billion dollars in sales. Flash forward to 2001, when the Women’s Health Initiative reported it carries an increased risk of breast cancer, stroke, heart attack and blood clots in the legs and lungs, confirming what many other studies had already previously reported. Premarin continues to be prescribed.

Contrast these examples with the unique case of Thalidomide, a drug sold in Europe, Canada, and the Middle East, said to be safe for treating morning sickness during pregnancy. When the application for its approval arrived at the FDA in 1960, it landed on the desk of Dr. Frances Oldham Kelsey, who expressed dissatisfaction with the quality of safety evidence presented. This led to a war of wills between Dr. Kelsey and the manufacturer, but she stood her ground demanding scientific rigor, and in so doing saved American women from the heartache of giving birth to babies with a characteristic birth defect, foreshortened, flipper-like limbs.

Which brings us full circle to breast implants. Since 2011, the first time the FDA officially recognized the association between lymph cancer and breast implants, 1.7 million implant surgeries have been performed in the U.S. Of the nearly 300,000 breast implant operations performed in 2016, one-third were for reconstruction and two-thirds were for breast enlargement. The trend for this wildly popular procedure is to perform it at younger and younger ages because, while not officially approved for young teens, it is legal. In 2014, eight thousand teenagers had breast augmentation, and it has become a commonly requested high school graduation gift. There are no long-term studies on the implantation risks in still-developing breasts but, with BIA-ALCL occurring on average ten years after implant placement, teens can expect this preventable cancer to occur when they are in their twenties.

Females should think long and hard about educating themselves fully before deciding to sign up for breast implant surgery. The short and long-term considerations should include, but not be limited to:

  • the risk of surgery and anesthesia
  • pain
  • change in the shape, consistency, and movement of the breast(s)
  • tenderness and lumpiness around the implant
  • unsatisfactory sexual response related to decreased sensitivity, numbness, and deformity
  • inadequate milk supply for breastfeeding
  • potential transfer of silicone, platinum and other toxic implant ingredients to breastfed offspring
  • implant recipients 3 – 4 times more likely to commit suicide, 2X more likely to die of brain cancer, 3X more likely to die of lung cancer, overall 21% increased cancer risk
  • ruptured implants associated with chronic, debilitating, potentially fatal autoimmune disorders
  • brain fog, trouble concentrating, memory loss
  • implants’ limited shelf life ensures more surgery will follow (50% rupture by 10 years, 90% rupture by 15-20 years)
  • mammograms less reliable for detecting cancer can rupture the implant
  • implant removal surgery is difficult, risky, can cause further breast deformity
  • valved saline implants associated with serious bacterial and fungal infections

Breast implantation is a multibillion-dollar windfall for participating manufacturers and doctors; for women, it’s a potential, scientifically proven nightmare. Interestingly, the FDA has not approved a silicone testicular implant due to inadequate testing.

Related Posts