Safety Updates 

1. March 2021, AZ SB1001 was signed into law.

Effective January 1, 2022, in Arizona, it requires a physician to provide a patient with a manufacturer patient information booklet and to obtain informed consent from the patient prior to surgery. This includes an informed consent checklist with information on BIA-ALCL, breast implant illness, National Breast Implant Registry (NBIR), how to report adverse effects to the FDA MedWatch Program, and more. Advocates are working on implementing this legislation in several other states.

“A physician who knowingly violates this section commits an act of unprofessional conduct and is subject to disciplinary action.” – AZ SB1001

2. August 2020, FDA update: ‘Medical Device Reports for Systemic Symptoms in Women with Breast Implants’

3. FDA has issued warning letters to all four breast implant manufacturers:

– March 2019  – FDA issues warning letters to two breast implant manufacturers [Mentor and Sientra] for failure to comply with post-approval study requirements

– May 2020 – FDA issued warning letters to two breast implant manufacturers (Allergan & Ideal).

“The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable. … Allergan’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s premarket approval order.” – FDA

4. October 2019, FDA released a statement on enhancing breast implant labeling recommendations including:

A black box warning, patient-decision checklist, product ingredient information including types and quantities of chemicals and heavy metals, silicone gel-filled breast implant rupture screening recommendations, and updated patient device card. A draft guidance was issued and was open to public comment until December 23, 2019.

5. Global Recall – Allergan BIOCELL Textured Breast Implants 

July 2019, FDA requested Allergan to recall its textured breast implants from the US market. Allergan responded with a global recall of silicone and saline textured breast implants and tissue expanders. This comes after more cases of BIA-ALCL have been reported. See FDA News Release July 2019, FDA News Release August 2019, FDA Medical Device Reports of BIA-ALCL, Allergan Recall, and NCHR. In September 2019, the FDA identified the Allergan recall as a Class I Recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

6. May 2019, FDA issued a new safety statement in response to the Medical Devices Advisory Committee Meeting on breast implant concerns held in March 2019.

[T]he current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed, referred to by some patients and health care professionals as breast implant illness.

We believe women considering a breast implant should be aware of these risks. As we describe below, we are taking steps to better characterize the condition and its risk factors, and are considering ways to help to ensure women have all of the information they need to make informed decisions about whether to obtain breast implants or to remove existing breast implants in an effort to reverse systemic symptoms. – FDA

7. April 2019, wave of regulatory actions as countries (France, Netherlands, Columbia, Canada) move to suspend textured breast implants. 

France is the first country to ban breast implants linked to heightened cancer risk of BIA-ALCL. France bans textured and polyurethane breast implants made by 6 manufacturers: textured Natrelle implants by Allergan; Monobloc textured implants by Arion; Silicone textured implants by SEBBIN; GFX, IMPLEO and COGEL implants by Nagor; MATRIX implants by Eurosilicone; and POLYtxt, Sublime Lime, Microthane and Diagon\Gel® 4Two implants by Polytech. Source: ICIJ 1.

Two days after France, the Netherlands announced plans to temporarily suspend textured and polyurethane breast implants. Sources: ICIJ 2.

Columbia temporarily suspends textured breast implants. Source: El Tiempo.

Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure (April 2019). Health Canada suspends Allergan’s licences for its Biocell breast implants after safety review concludes an increased risk of cancer (May 2019). Source: Health Canada.

8. FDA kept hidden 350,000 reports of breast implants problems 

March 2019, during the FDA public meeting on reviewing breast implant concerns, it was revealed that over 350,000 reports of problems with breast implants from the last decade have been hidden from the public in Alternative Summary Reporting (ASR); where manufactures combined up to thousands of breast implant reports of malfunctions, problems, and injuries into single summaries instead of as individual reports. See Reports of problems with breast implants hidden from public and FDA kept hundreds of thousands of breast implant incidents hidden from public.Click here to read more.

Madris Tomes, a former FDA data analyst and the founder of Device Events, testified at the FDA hearing (go to 6:37:36) as a Data and Patient Advocate and revealed the FDA’s faulty Summary Reporting. She states, “Adverse event data should never be withheld from the public. This hurts both patients and physicians, and ultimately harms the US Health Care System. We all pay when the Manufacturers cannot be held accountable and are protected by the FDA.”

The FDA has stopped using ASRs for most medical devices as of 2017 and is working on making the information available to the public.

9. March 2019, FDA officially added ‘Systemic Symptoms (Breast Implant Illness (BII))‘ to their Risks of Breast Implants.

10. March 2019, FDA issued warning letters to two breast implant manufacturers (Mentor and Sientra) for failure to comply with post-approval study requirements.

11. Allergan denied renewal of EU safety certificate and begins a “voluntary recall”

December 2018, Allergan textured breast implants (Biocell and Microcell) were denied renewal of their European 5-year safety certificate, known as CE mark, and was followed by a “voluntary recall” from the market. Source: FDA General and Plastic Surgery Devices Panel Meeting, Dr. Mark Clemens (4:42:00). In February 2019, citing the CE expiration, Saudi Arabia also issued a recall of Allergan textured breast implants. Source: Saudi Food & Drug Authority.