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by Dr. Gregory T. Lynam

Implant Recall News

Breast implants are modern medical devices that are constantly
evolving and changing over time. Stay informed of the latest
news and developments in implant safety and care.

What are the latest investigative sources saying about textured breast implants?

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants:

“…Today, the agency is providing an updated number of medical device reports (MDRs), also known as adverse event reports. After a thorough data analysis, we are reporting that, as of September 2018, the agency has received a total of 660 total medical device reports regarding BIA-ALCL cases since 2010. Of the 660 MDRs, our in-depth analysis suggests that there are 457 unique cases of BIA-ALCL, including 9 patient deaths.

We understand that the information presented shows an increase of 246 new MDRs since last year. Given the agency’s continued efforts to communicate with stakeholders about BIA-ALCL risks and our work to encourage patients and providers to file MDRs with the agency, these types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA. The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis…”

From The Independent:

“A type of cancer linked to breast implants has been diagnosed in more women, according to a statement from the Food and Drug Administration (FDA)… Nine women have died from the rare cancer that affects the immune system, a known risk from breast implants that was first reported by the FDA in 2011.

While the slow-growing lymphoma is not breast cancer, it is found around breast implants. Health officials also explained the lymphoma is more likely to occur in women who have implants with a textured coating rather than a smooth coating. Textured implants, which have a rougher outer layer meant to adhere to tissue surrounding them, are typically used in cases where the patient and surgeon do not want the implant to move around within the breast pocket.

https://www.independent.co.uk/news/world/americas/breast-implants-cancer-risk-fda-lymphoma-lift-texture-chemotherapy-radiation-a8768231.html

Penn State article:

In a Penn State news article dated 10/18/2018 and entitled Rare Cancer Linked with Breast Implants may be Underreported, Misunderstood, reporter Katie Bohn writes, “ A rare cancer in patients with breast implants may be on the rise, but not all patients and physicians may be aware of the risks associated with the procedure, according to a group of Penn State College of Medicine researchers…We’re seeing that this cancer is likely very underreported, and as more information on this type of cancer comes to light, the number of cases is likely to increase in the coming years,” said Dino Ravnic, assistant professor of surgery, Penn State College of Medicine. “We’re still exploring the exact causes, but according to current knowledge, this cancer only really started to appear after textured implants came on the market in the 1990s…” The full article can be read here: https://news.psu.edu/story/488829/2017/10/18/research/rare-cancer-linked-breast-implants-may-be-underreported

NBC News Investigation: Textured Breast Implants

According to NBC News, “When Michelle Forney’s breast started swelling and itching, doctors told her she had mastitis, a common infection, and treated her with antibiotics. When she discovered that she, in fact, had a rare form of lymphoma and that it was probably caused by her breast implant, she was both furious and frightened. Forney is just one of hundreds of breast-implant recipients who have developed a rare blood cancer called anaplastic large cell lymphoma (ALCL). The Food and Drug Administration has been investigating reports linking breast implants with the cancer, and now has more than 400 reports about patients who developed ALCL after having a breast implant, including nine who died…”

The full article and video can be found here:https://www.nbcnews.com/nightly-news/video/doctors-patients-raise-alarms-about-cancer-linked-to-breast-implants-1381021763837 and https://www.nbcnews.com/health/health-news/fda-affirms-breast-implants-can-cause-rare-form-cancer-n736551?icid=related

The Guardian:

“A type of breast implant used by millions of women around the world is under scrutiny after French surgeons were advised to stop using it because of a potential link with a rare kind of cancer.

Textured breast implants have been linked with anaplastic large cell lymphoma (ALCL), which forms in the scar capsule around the implant and normally begins with pain and swelling in the breast.

Women who have the implants and capsules removed can make a full recovery, but if left untreated the disease can spread throughout the body and become life-threatening…”

https://www.theguardian.com/society/2018/nov/26/rare-cancer-linked-breast-implant-used-by-millions-women-lymphoma

Fortune:

“France’s national health regulator refused to renew approval Tuesday for two types of Allergan textured breast implants. That means Allergan cannot sell its Microcell and Biocell textured breast implants in Europe.

The agency advises patients with the implants to undergo regular checks with their doctors for a blood cancer called anaplastic large cell lymphoma (ALCL), which occurs more often in women with textured breast implants. Plastic surgeons have identified more than 600 cases worldwide. ALCL is treatable.

The U.S. Food and Drugs Administration permits the sale of such implants despite knowing since 2011 about the increased risk. Last week the agency agreed to hold a meeting of medical advisors in 2019 to address concerns.

In November, the International Consortium of Investigative Journalists reported on the lack of transparency and rigor in government oversight of medical devices. U.S. figures alone revealed an average of 8,000 deaths a year linked to medical devices. The breast implant cases were one of those highlighted in the reporting.

The Guardian estimates that the medical technology market in Europe is worth around $125 billion a year, so regulators are up against a lot of economic heft.

Worried about your own implant? The ICIJ has built a database noting more than 70,000 recalls, safety alerts, and other device-related medical notices.

http://fortune.com/2018/12/19/europe-bans-allergan-breast-implants/.

ICIJ database: https://medicaldevices.icij.org/

European Recall in US News Regarding Textured Implants

USA Today reported, “Biopharmaceutical company Allergan is recalling rough-surface breast implants in Europe. The company said its breast implants are safe and it’s not recommending surgical removal, which can cause health problems. But it will no longer offer the “textured” version in Europe.

Smooth implants will be sold there.

The move comes after a French regulatory agency asked the company to take action after the textured produce lost its CE Mark health-and-safety certification. Some researchers have raised concerns about a cancer risk connected to certain textured implants…”

The full article can be found here: https://www.usatoday.com/story/money/2018/12/19/allergan-textured-breast-implant-recall/2360954002/

In Global Healthcare Knowledge Provider Journal, BMJ:

One of the world’s best-selling types of silicone breast implants, which have been linked to a rare form of atypical lymphoma (BIA-ALCL), have been removed from the market across Europe.The recall of Allergan textured implants came after the French national agency for the safety of medicines and health products (ANSM) said it was suspending the ConformiteEuropeene (CE) mark for Allergan’s Microcell and Biocell products. It means that, for now, the implants cannot be manufactured or sold in Europe and those held at clinics are being recalled.

https://www.bmj.com/content/363/bmj.k5401.full

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