Silicone Breast Implants to Carry Cancer Warning in France

Troy Brown, RN

March 24, 2015

Breast implants in France will now carry a warning after France's National Cancer Institute found a "clear link" between silicone implants and anaplastic large cell lymphoma (ALCL), according to a news release from the Ministry of Social Affairs, Health and Women's Rights (ANSM), France. France is considering a general ban on the implants.

Eighteen women have been identified with breast implant–associated ALCL in France since 2011, but France's National Cancer Institute says women do not need to have the implants removed, because the cancer is so rare.

Common Procedure, Rare Cancer

Approximately 80% of breast implants are performed for cosmetic reasons, and 20% are done for reconstructive purposes. An estimated 400,000 women in France currently have breast implants. In the United States, breast augmentation is the most frequently performed cosmetic surgery, with 286,254 procedures performed in 2014, according to data from the American Society of Plastic Surgeons.

ALCL is a rare and aggressive type of non-Hodgkin's lymphoma that is typically of the T-cell type, according to the US National Cancer Institute. It may be found in the lymph nodes, skin, bones, soft tissues, lungs, or liver. Breast implant–associated ALCL is rarer still.

Breast implant–associated ALCL is only found in the breast, but it is not breast cancer. The prognosis is usually good.

According to the National Cancer Institute, ALCL is diagnosed in about 1 in 500,000 women a year in the United States — and ALCL in the breast is diagnosed in only 3 in 100 million women a year in the United States.

"Currently, there is not a definitive correlation between breast implants and the development of breast implant–related [ALCL]. The first index case was reported in 1997, yet it is important to note that breast implants have been used since 1962, with current numbers showing there are over 10 million women in the world with breast implants. In the world's literature, there are less than 140 cases reported," Michael C. Edwards, MD, FACS, a plastic surgeon from Anson, Edwards and Higgins Plastic Surgery Associates, Las Vegas, Nevada, told Medscape Medical News.

"It is extremely rare; a cosmetic implant patient is twice as likely to be struck by an asteroid as to develop implant–associated ALCL. This does not imply that it is not considered very important. Quite the contrary, a concerted effort is under way to learn more about this rare condition to include the potential causes, screening, and diagnostic evaluation and recommended treatment," he said.

Breast Implants Have Checkered Past

France strengthened its monitoring of breast implants after French breast implant maker Poly Implant Prothese (PIP) was found guilty of using industrial-grade silicone in its implants in 2010. Abnormally high numbers of the faulty implants ruptured, and the French government encouraged women to have them removed. Jean-Claude Mas, 74, company founder and chief executive, was sentenced to 4 years in jail. The company closed in 2010, and France banned the PIP implants.

The European Commission established a task force to exchange data on ALCL and to facilitate cooperation between the 28 member states.

In January 2011, the US Food and Drug Administration (FDA) announced that patients with saline- or silicone gel–filled implants may have a very small but significant risk of developing ALCL adjacent to the implant. At that time, the FDA advised clinicians to consider the possibility of ALCL in patients with breast implants who developed late-onset persistent peri-implant seroma. The FDA also instructed clinicians to report to the FDA confirmed cases of the disease in women with breast implants.

New ALCL Cases Triggered Investigation

Marisol Touraine, minister of social affairs, health and women's rights in France, was informed that nine cases of ALCL were identified in 1 year, bringing the total number of cases identified in France since 2011 to 18, according to an ANSM news release.

Touraine then met with experts, including those from France's National Cancer Institute, and on March 4, 2015, the expert group made its recommendations. The recommendations were published and disseminated to appropriate healthcare professionals.

The ANSM established an ad hoc group of experts to further investigate the role of breast implants in the development of ALCL. In addition, the High Authority for Health was asked to develop recommendations regarding the indications and contraindications for breast implants, restrictions on their use, and possible alternatives to their use.

Minister Touraine filed an amendment to the Health System Modernization Act to improve the monitoring and traceability of breast implants by requiring manufacturers to provide a summary of product characteristics to ANSM and to keep records in health facilities.

Role of Textured Breast Implants Unclear

Breast implants have a surface that is either textured or smooth. Textured breast implants are believed to help the implant remain in place and to reduce the occurrence of capsular contracture. The FDA notes that some scientists believe textured implants increase the risk for ALCL, but this has not been proven.

"Of the 18 cases reported in France since 2011, in the majority of cases of ALCL, there are so-called 'textured' implants, but they also constitute the majority of prostheses currently located in France," the information sheet from the ANSM and the National Cancer Institute, France, explains. "Formally [we] cannot exonerate the smooth structure of prostheses."

Annual Follow-up Recommended

"[Women] with breast implants or those considering aesthetic breast surgery...can take comfort that implant–associated ALCL is very rare. [They] should see a board-certified plastic surgeon for...care and follow-up on an annual basis or if there are ever concerns about [their] breasts," Dr Edwards, who is also president of the American Society for Aesthetic Plastic Surgery, Clark County Medical Society, Nevada, said.

For now, Minister Touraine recommends that monitoring of women with breast implants should be the same as that for all women:

  • Women should have a clinical breast examination by their doctor or midwife every year from age 25.

  • From age 50, women should have a mammogram every 2 years, and those with an aggravated risk for cancer should receive specific monitoring.

  • Women with breast implants who develop effusion, enlargement, pain, inflammation, mass, ulceration, or impaired general condition should consult their physician.

  • Experts do not recommend that women with breast implants ask for their removal.

"In the extremely rare case where a diagnosis of ALCL is made, the treatment is removal of the capsule as completely as possible and even reconstructing with a smooth implant," Dr Edwards added.

FDA Not Likely to Require Similar Warning

Dr Edwards said he does not expect the FDA to require similar warnings with breast implants in the United States. "The FDA currently asserts that because the risk of ALCL appears to be very small, 'the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled,' " he said.

"It is very important to note that the incidence and occurrence of this very rare condition will continue to be studied with data collated by board-certified plastic surgeons both in the United States and from around the world. The American Society for Aesthetic Plastic Surgery and the Aesthetic Surgery Research Foundation take this seriously, as with any aspect relating to patient safety. Current research is being funded by the Aesthetic Surgery Research Foundation to identify markers that may help with diagnosis, risk stratification, and possible treatment. Member plastic surgeons are made aware of what to look for in the evaluation, diagnosis, and treatment of the rare condition," Dr Edwards explained.

To report adverse events related to breast implants, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA- 0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Dr Edwards has disclosed no relevant financial relationships.

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